Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients
Latest Information Update: 16 Jan 2024
At a glance
- Drugs Sarconeos (Primary)
- Indications COVID-19 pneumonia; Respiratory insufficiency
- Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
- Acronyms COVA
- Sponsors Biophytis
- 04 Jan 2024 According to a Biophytis Media Release, company announced publication of phase 2/3 COVA results in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet.
- 04 Jan 2024 Results presented in a Biophytis Media Release.
- 26 May 2023 According to a Biophytis media release, the company expects response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023.
Most Recent Events
Trial Overview
Outcome
Purpose
This is a global, multicenter, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19.
Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19.
Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function from 310 COVID-19 patients (including the 50 patients from Part 1 of the study). Due to the evolution of the pandemia, the company decided
in April 2022 to stop enrolment at 237 enrolled patients, below the originally planned number of 310.
Comments
According to a Biophytis media release, the company has filed through its pharmaceutical partner Intsel Chimos, an application for Early Access Authorisation (EAA) in France with the French National Authority for Health (HAS) for the use of Sarconeos (BIO101)1 in the treatment of adult patients with a severe form of COVID-19, who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate. The company response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023.
According to a Biophytis media release, A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter. The company is moving forward with preparing regulatory filings to apply for conditional Marketing Authorization (cMA) in Europe and Emergency Use Authorization (EUA) in the USA,
According to a Biophytis media release, the company has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19. Depending on EMA's recommendations, the company could envision filing a conditional MA in the second half of 2023 or the first half of 2024.
According to a Biophytis media release, the company will be sharing these results in the coming months with regulatory agencies, health authorities and our partners in Europe, the United States and Brazil to determine under what conditions we could pursue the development of Sarconeos (BIO101) in COVID-19.
According to results presented at the 119th International Conference of the American Thoracic Society, trial ended early for stalled recruitment.
According to a Biophytis media release, company aims to file conditional marketing authorisation (Europe) and emergency use authorization (USA, Brazil) as soon as possible in 2023.
According to ClinicalTrials.gov record, This trial was Discontinued. Reason the study was stopped: Lack of eligible patients due to lower number of Covid-19 cases in all involved sites.
Primary Endpoints
the proportion of patients who died or required high-flow oxygen, mechanical ventilation or ECMO was analysed using Cochran-Mantel-Haenszel (CMH) test. [1]
For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.
description: • Proportion of participants with of subjects with negative events, of either of the following.
All-cause mortality
Respiratory failure, defined as any of the following:
Mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
time_frame: up to 28 days [2]
For end-of-part-1 interim analysis
For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:
Safety and tolerability to BIO101:
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:
End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.
description: For interim analysis intended to obtain indication of activity of BIO101.
Primary endpoint:
• Proportion of subjects with negative events, of either of the following:
All-cause mortality
Respiratory failure, defined as any of the following:
Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
time_frame: up to 28 days
For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.
description: For sample size re-assessment for part 2, time frame - up to 28 days:
• Proportion of participants with negative events, of either of the following:
All-cause mortality
Respiratory failure, defined as any of the following:
Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring high-flow oxygen
time_frame: up to 28 days
Safety and tolerability to BIO101
• SUSARs, SAEs, AESIs, AEs
• Vital signs
• Safety labs (including testicular biomarkers)
• ECGs
Other Endpoints
Interim analysis; indication of activity of BIO101: Oxygen saturation by pulse oximetry (SpO2) SpO2 / Fraction of inspired oxygen (FiO2) ratio
description: • SpO2/FiO2 time_frame: 28 days
Interim analysis; indication of activity of BIO101: Inflammatory markers
description: • Inflammatory markers including: IL 6 TNFα D-dimer time_frame: 28 days
Interim analysis; indication of activity of BIO101: Renin Angiotensin System biomarkers
description: • Renin Angiotensin System biomarkers: Angiotensin 2 Angiotensin-converting enzyme (ACE) levels time_frame: 28 days
Key secondary endpoint for final analysis: Proportion of participants with positive events
description: • official discharge from hospital care by the department due to improvement in participant condition (self-discharge by participant is not considered a positive event) time_frame: Up to 28 days
Additional secondary endpoints for final analysis: Respiratory function
description: Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2) SpO2/FiO2 Proportion of participants with CPAP/BiPAP events, defined as requiring CPAP/BiPAP/HFO2 in participants entering the study on low flow oxygen) time_frame: 28 days
Additional secondary endpoints for final analysis:proportion of patients who experienced negative events
description: Time to events, of either of the following: All-cause mortality Respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage); Requiring ECMO; • Proportion of participants with CPAP/BiPAP/HFO2 events, defined as requiring CPAP/BiPAP/HFO2 in participants entering the study on low flow oxygen) time_frame: 28 days
Additional secondary endpoint for final analysis: The National Early Warning Score 2 (NewS2)
description: National Early Warning Score 2 (NewS2): scores: 0-7 time_frame: 28 days
Additional secondary endpoint for final analysis: Population Pharmacokinetics study (pop-PK)
description: Cmax: Peak Plasma concentration time_frame: 1day
Additional secondary endpoint : Population Pharmacokinetics study (pop-PK)
description: tmax: Time to reach peak plasma concentration time_frame: 1 day
Additional secondary endpoint: Population Pharmacokinetics study (pop-PK)
description: AUC: Area under the plasma concentration versus time curve time_frame: 1 day
Additional secondary endpoint: Proportion of participants with events of all-cause mortality
description: Proportion of participants with events of all-cause mortality time_frame: Up to 28 days
Additional secondary endpoint: time to event: negative events
description: Time to events, of either of the following: All-cause mortality Respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO time_frame: Up to 28 days
Additional secondary endpoint: time to event: positive events
description: Time to event: official discharge from hospital care due to improvement time_frame: Up to 28 days [3]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID-19 pneumonia | treatment | severe |
| Respiratory insufficiency | prevention | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04472728 | Angiotensin II | Outcome Measure |
| Angiotensin-converting enzyme (ACE | Outcome Measure | |
| D-dimer | Outcome Measure | |
| gamma-glutamyltransferase 2 | Eligibility Criteria | |
| gamma-glutamyltransferase light chain 3 | Eligibility Criteria | |
| GGT | Eligibility Criteria | |
| GGTLC4P | Eligibility Criteria | |
| GGTLC5P | Eligibility Criteria | |
| Interleukin-6 (IL-6) | Outcome Measure | |
| Renin | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 465
Actual: 237
- Sex male & female
- Age Group ≥ 45 years (mean age 63 years); adult; elderly
Patient Inclusion Criteria
1. Age: 45 and older (in France: 55 and older) 2. A confirmed diagnosis of COVID-19 infection, within the last 28 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used. 3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration ≥3 days a. Patients can be included even if treated with: oxygen supplementation, High-flow oxygen (HFO2), BiPAP and CPAP 4. With evidence of pneumonia based on all of the following: 1. Clinical findings on a physical examination 2. Respiratory symptoms developed within the past 14 days 5. With evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff: 1. Tachypnea: ≥25 breaths per minute 2. Arterial oxygen saturation ≤92% 3. A special note should be made if there is suspicion of COVID-19- related myocarditis or pericarditis, as the presence of these is a stratification criterion 6. Without a significant deterioration in liver function tests: 1. ALT and AST ≤ 5x upper limit of normal (ULN) 2. Gamma-glutamyl transferase (GGT) ≤ 5x ULN 3. Total bilirubin ≤ 5×ULN 7. Willing to participate and able to sign an informed consent form (ICF) 8. Female subjects should be: at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile; OR 1. Have a negative urine pregnancy test at screening 2. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. Male subjects who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product; Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy. 10. Male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product; 11. For France only: Being affiliated with a European Social Security.
Patient Exclusion Criteria
1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) 2. Moribund condition (death likely in days) or not expected to survive for >7 days - due to other and non-COVID-19 related conditions 3. Patient on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO) 4. Patient within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or recombinant ACE-2 5. Patient not able to take medications by mouth (as capsules or as a powder, mixed in water). 6. Disallowed concomitant medication: a. Consumption of any herbal products containing 20-hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents) 7. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 8. In France: - Non-affiliation to compulsory French social security scheme (beneficiary or right-holder) - Being under tutelage or legal guardianship
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04472728 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2020-001498-63 | European Clinical Trials Database |
| BIO101CL05 | - |
| BIO101 | - |
Organisations
- Sponsors Biophytis
- Affiliations Biophytis; Intsel Chimos
Trial Dates
-
Initiation Dates
Actual : 26 Aug 2020
-
Primary Completion Dates
Planned : 01 Jun 2022
Actual : 06 Jun 2022
-
End Dates
Planned : 30 Sep 2022
Actual : 30 Sep 2022
Other Details
- Design double-blind; multicentre; prospective; randomised; sequential
- Phase of Trial Phase II/III
- Location Belgium; Brazil; Europe; France; Latin America; Puerto Rico; United Kingdom; USA
- Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| SarconeosPrimary Drug | Oral | Capsule |
BIO101
BIO101 350 mg bid
Drug: BIO101 (BIO101 capsules) Other Name: Sarconeos (BIO101)
Placebo
Placebo
Drug: Placebo (placebo capsules) Other Name: Sarconeos (placebo)
Results
Therapeutic efficacy
Phase II/III: Updated results from the phase II/III COVA trial demonstrated that primary Cochran-Mantel-Haenszel (CMH) test at day 28 showed a statistically significant difference favoring BIO 101 (BIO101: 15.8%, placebo: 26.0%), adjusted difference 11.4% (p=0.042), a relative risk (RR) reduction of early death or respiratory failure of 44% (greater than expected). A difference was also seen for time to respiratory failure or early death showing a nominally statistically significant difference over 28 days (Hazard ratio=0.49, stratified logrank p=0.022). Proportion of recovered patients showed a strong trend towards benefit of BIO 101 (adjusted difference 11.0%, p= 0.059) [1] . Earlier results demonstrated that the trial met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19 (n = 54). The pre-specified analysis of time to death over the complete follow-up period over 90 days showed that mortality rate with sarconeos was reduced compared to placebo in the intent to treat (ITT) population (p = 0.083) and in the per protocol (PP) population (p = 0.038) [2] . In the trial in 233 patients with COVID-19-related respiratory failure, results demonstrated that sarconeos (350 mg, twice daily) showed the reduction in the risk of respiratory failure or early death at 28 days by 39% compared to placebo (15.8% vs 26.0%, adjusted difference 11.8% in favor of treatment, p=0.07). The proportion of patients with respiratory failure (12.7% vs 21.5%) and early death (0.8% vs 2.8%)both was reduced by sarconeos. It also significantly (p=0.03) delayed the progression of respiratory failure or early death over 28 days maximum treatment period. Sarconeos (BIO101) reduced the risk of death at 28 days compared to placebo, in similar proportion to the observed reduction in the risk of respiratory failure or early death and delayed its occurrence within 90 days. These effects are nonetheless not statistically significant [4] .
Adverse events
Phase II/III: Updated results from the phase II/III COVA trial demonstrated that safety and tolerability of BIO101 was very good: less patients treated with BIO101 experienced adverse events (AEs) compared to placebo (57.0% vs 64.4%), due to higher incidence of respiratory events in the placebo group [1] . Earlier results showed a reduction in the risk of early death or respiratory failure at day 28 of 45% in the intent-to-treat (ITT) population and 53% in the per protocol (PP) population as well as a reduction in the risk of death at day 90 of 43% in the ITT population and 70% in the PP population [5] . In phase II/III COVA study, sarconeos (BIO101) showed a good safety profile, with a similar proportion of adverse events compared to placebo, particularly severe adverse events (25% vs 31%). In addition, more patients in the placebo group experienced respiratory adverse events than patients in the Sarconeos (BIO101) group (32.7% vs 22.7%, respectively), supporting the main efficacy results [4] .
Publications
-
Nair GB, Dioh W, Chabane M, Tourette C, Rabut S, Louze M, et al. Cova Results From a Double-blind, Placebo-controlled Phase 2/3 Study to Assess Efficacy and Safety of BIO101 in Hospitalized Severe COVID-19 Patients. ATS-2023 2023; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/8931 -
Biophytis. BIOPHYTIS ANNOUNCES POSITIVE FINAL RESULTS OF THE PHASE 2-3 COVA STUDY WITH SARCONEOS (BIO101) IN SEVERE COVID-19. Media-Rel 2023;.
Media Release -
Biophytis. Biophytis Announces Very Promising Top Line Results of its Phase 2-3 COVA Clinical Study in COVID-19-Related Respiratory Failure. Media-Rel 2022;.
Media Release -
Biophytis. BIOPHYTIS ANNOUNCES THE PUBLICATION OF THE RESULTS OF ITS COVA PHASE 2-3 STUDY IN ECLINICALMEDICINE, PART OF THE LANCET. Media-Rel 2024;.
Media Release -
Biophytis. Biophytis Presented Positive Results of Phase 2-3 COVA Study At The American Thoracic Society International Conference. Media-Rel 2023;.
Media Release -
Biophytis. BIOPHYTIS REPORTS THE POSITIVE POST-HOC ANALYSIS OF THE COVA PHASE 2-3 STUDY STRONGLY SUPPORTING THE THERAPEUTIC POTENTIAL OF SARCONEOS (BIO101) IN SEVERE FORMS OF COVID-19. Media-Rel 2022;.
Media Release
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Alpesh Nair, MD | University of California, Irvine | USA |
| Arnaud Desclaux, MD | Centre Hospitalier Universitaire Bordeaux | France |
| Capucine Morelot-Panzini, MD | Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière |
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|
| Capucine Morélot-Panzini, MD | Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital | France |
| Christopher Lipinski, MD | Abrazo Health | USA |
| Claudio Stadnik, MD | Santa Casa de Porto Alegre | Brazil |
| DeVit, MD | CHU Saint-Pierre | Belgium |
| Edouard Devaud, MD | Centre Hospitalier Rene Dubos | France |
| Fernando Neuenschwander, MD | Hospital Vera Cruz | Brazil |
| Gaetan Plantefeve, MD | Centre Hospitalier Argenteuil | France |
| Girish Nair, MD | Beaumont Health | USA |
|
Jean Martinot, MD
martinot.j@respisom.be
show details
|
CHU CLU Namur (Saint-Elisabeth) Place Louise Godin | Belgium |
| Jeffrey Gray, MD | United Health Services Hospitals | USA |
| Lee Maddox | WellSpan Health | USA |
| Ludhmila A Hajjar, MD | Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar | Brazil |
| Maria Patelli Lima, MD | Hospital e Maternidade Celso Pierro - PUCCAMP | Brazil |
|
Muriel Lins, MD
+3215892040 muriel.lins@Emmaus.be
show details
|
AZ-Sint Maarten | Belgium |
| Nara Moraes, MD | Hospital Municipal de Barueri Dr. Francisco Moran | Brazil |
| Otis Barnum, MD | Barnum Medical Research, Inc. 1029 Keyser Ave Suite H | USA |
| Ricardo Fernandez, MD | FDI Clinical Research - San Juan City Hospital | Puerto-Rico |
|
Shmuel Agus, MD
+16176424891
show details
sam.agus@biophytis.com |
Biophytis S.A. |
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|
| Stéphane De Wit, MD | CHU Saint-Pierre | Belgium |
| Suzanna Lobo, MD | Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto | Brazil |
| Thomas Guimard, MD | Centre Hospitalier Départemental de Vendée | France |
| Valerie Pourchet, MD | Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris | France |
|
Waly Dioh, PhD
+33144272339
show details
waly.dioh@biophytis.com |
Biophytis S.A. |
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|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Abrazo Health | Phoenix, Arizona | USA |
| Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar | São Paulo | Brazil |
| AZ-Sint Maarten | Mechelen | Belgium |
| Barnum Medical Research, Inc. 1029 Keyser Ave Suite H | Natchitoches, Louisiana | USA |
| Beaumont Health | Royal Oak, Michigan | USA |
|
Biophytis S.A.
+33(0)144 27 23 87
show details
B.5.6 E-mail mounia.chabane@biophytis.com |
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|
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|
| Centre Hospitalier Argenteuil | Argenteuil | France |
| Centre Hospitalier Départemental de Vendée | La Roche-sur-Yon | France |
| Centre Hospitalier Rene Dubos | Cergy-Pontoise | France |
| Centre Hospitalier Universitaire Bordeaux | Bordeaux | France |
| CHU CLU Namur (Saint-Elisabeth) Place Louise Godin | Namur | Belgium |
| CHU Saint-Pierre | Brussel | Belgium |
| CHU Saint-Pierre | Brussels | Belgium |
| Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière |
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|
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| FDI Clinical Research - San Juan City Hospital | San Juan | Puerto-Rico |
| Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto | São José Do Rio Preto, São Paulo | Brazil |
| Hospital e Maternidade Celso Pierro - PUCCAMP | Campinas, São Paulo | Brazil |
| Hospital Municipal de Barueri Dr. Francisco Moran | Barueri, São Paulo | Brazil |
| Hospital Vera Cruz | Belo Horizonte, Minas Gerais | Brazil |
| Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris | Paris | France |
| Santa Casa de Porto Alegre | Porto Alegre, Rio Grande Do Sul | Brazil |
| United Health Services Hospitals | Johnson City, New York | USA |
| Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital | Paris, Paris Cedex 13 | France |
| University of California, Irvine | Irvine, California | USA |
| WellSpan Health | York, Pennsylvania | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 04 Jan 2024 | Results | According to a Biophytis Media Release, company announced publication of phase 2/3 COVA results in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet. Updated 16 Jan 2024 |
| 04 Jan 2024 | Results | Results presented in a Biophytis Media Release. Updated 16 Jan 2024 |
| 26 May 2023 | Other trial event | According to a Biophytis media release, the company expects response by Q3 2023 at the latest, depending on the delays taken by the HAS, and the first patients could be treated as early as Q4 2023. Updated 02 Jun 2023 |
| 26 May 2023 | Other trial event | According to a Biophytis media release, the company has filed through its pharmaceutical partnerIntsel Chimos, an application for Early Access Authorisation (EAA) in France with the French National Authority for Health (HAS) for the use of Sarconeos (BIO101)1 in the treatment of adult patients with a severe form of COVID-19, who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate. Updated 02 Jun 2023 |
| 25 May 2023 | Results | Results presented in the Biophytis Media Release. Updated 30 May 2023 |
| 25 May 2023 | Other trial event | According to a Biophytis media release, the company is moving forward with preparing regulatory filings to apply for conditional Marketing Authorization (cMA) in Europe and Emergency Use Authorization (EUA) in the USA. Updated 30 May 2023 |
| 25 May 2023 | Results | According to a Biophytis media release, data from this trial were presented at the American Thoracic Society International Conference 2023. Updated 30 May 2023 |
| 24 May 2023 | Endpoint met | Primary endpoint has been met, (the proportion of patients who died or required high-flow oxygen, mechanical ventilation or ECMO was analysed using Cochran-Mantel-Haenszel (CMH) test.), as per Results presented at the 119th International Conference of the American Thoracic Society Updated 12 Jul 2023 |
| 24 May 2023 | Results | Results presented at the 119th International Conference of the American Thoracic Society Updated 12 Jul 2023 |
| 17 May 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 17 May 2023 |
| 09 May 2023 | Other trial event | According to a Biophytis media release, A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter. Updated 12 May 2023 |
| 09 May 2023 | Other trial event | According to a Biophytis media release, the company has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19. Depending on EMA's recommendations, the company could envision filing a conditional MA in the second half of 2023 or the first half of 2024. Updated 12 May 2023 |
| 27 Mar 2023 | Results | According to a Biophytis media release, data from this study presented at the 13th annual International Conference on Frailty and Sarcopenia Research (ICFSR). Updated 28 Mar 2023 |
| 09 Mar 2023 | Other trial event | According to a Biophytis media release, following the positive results from this trial, the company met with the French National Authority for Health (HAS) for a pre-submission meeting to review the eligibility requirements of the application. Updated 02 Jun 2023 |
| 09 Mar 2023 | Results | Positive results of this study presented at the 21ST ERS 2023 LUNG SCIENCE CONFERENCE-15 Mar 23. Updated 20 Apr 2023 |
| 09 Mar 2023 | Other trial event | According to a Biophytis media release, positive results of this study present at the European Respiratory Society 2023 21st Lung Science Conference, company will also present a poster that will be available on Biophytis website after the conference, data will be present to the scientific community. Updated 14 Mar 2023 |
| 27 Feb 2023 | Other trial event | According to Biophytis media release, company anticipates the filing of application formally with an objective of approval to start this program the Q2 of 2023. Updated 03 Mar 2023 |
| 27 Feb 2023 | Other trial event | According to Biophytis media release, company has initiated the process of early access application in France with the French National Authority. Updated 03 Mar 2023 |
| 23 Feb 2023 | Other trial event | According to a Biophytis media release, company announced, renewal of authorizations granted at Jun 2022 AGM. Updated 27 Feb 2023 |
| 23 Feb 2023 | Other trial event | According to a Biophytis media release, resolutions relating to capital increases were published in BALO on Wed, 22 Feb 2023. Updated 27 Feb 2023 |
| 23 Feb 2023 | Other trial event | According to a Biophytis media release, company announced, it is convening an Extraordinary and Ordinary Shareholders' Meeting for 30 Mar 2023. Updated 27 Feb 2023 |
| 02 Feb 2023 | Results | According to Biophytis media release, company announced final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on 7 Sep 2022. Updated 03 Mar 2023 |
| 02 Feb 2023 | Results | Positive final results published in the Biophytis Media Release. Updated 14 Feb 2023 |
| 02 Feb 2023 | Endpoint met | Primary endpoint (For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.) has been met, according to a Biophytis media release. Updated 14 Feb 2023 |
| 05 Jan 2023 | Other trial event | According to a Biophytis media release, latest results from this study will be discussed at 41st JP Morgan Healthcare Conference, and at the Invest Securities Biomed Event Updated 09 Jan 2023 |
| 21 Dec 2022 | Status change - discontinued | Status changed from active, no longer recruiting to discontinued. Updated 23 Dec 2022 |
| 01 Dec 2022 | Other trial event | According to a Biophytis media release, company invited all its shareholders to an online event where Key Opinion Leaders as well as Biophytis management will present an update of COVID-19 pandemic and the results of this study. Updated 05 Dec 2022 |
| 03 Nov 2022 | Results | Results published in the Media Release Updated 10 Mar 2023 |
| 03 Nov 2022 | Other trial event | According to a Biophytis media release, company plans to file conditional marketing authorisation (Europe) and emergency use authorization (USA, Brazil) as soon as possible in 2023. Updated 02 Mar 2023 |
| 03 Nov 2022 | Other trial event | According to Biophytis media release, company will present results in detail during upcoming scientific conferences in the first half of 2023 and in a peer-reviewed scientific journal. Updated 02 Mar 2023 |
| 03 Nov 2022 | Results | Full results and post-hoc analysis results of this study were presented in a Biophytis media release. Updated 02 Mar 2023 |
| 15 Sep 2022 | Other trial event | According to Biophytis media release, company presented first results of this trial to investors on 12 Sep in New York, on the occasion of the 24th Global Investment Conference organised by the HC Wainwright bank, which is being held from 12 to 14 Sep 2022 in New York. Updated 03 Mar 2023 |
| 07 Sep 2022 | Other trial event | According to a Biophytis media release, the company will be sharing these results in the coming months with regulatory agencies, health authorities and our partners in Europe, the United States and Brazil to determine under what conditions we could pursue the development of Sarconeos (BIO101) in COVID-19. Updated 08 Sep 2022 |
| 07 Sep 2022 | Other trial event | According to a Biophytis media release, results of further analysis will be communicated to the market and presented in details during a major international scientific conference in the next months. Updated 08 Sep 2022 |
| 07 Sep 2022 | Other trial event | According to a Biophytis media release, Dr Girish Balachandran Nair is the Principal Investigator of the this study in USA. Updated 08 Sep 2022 |
| 07 Sep 2022 | Interim results | Topline results published in the Biophytis Media Release. Updated 08 Sep 2022 |
| 27 Jul 2022 | Completion date | Planned End Date changed from 1 Sep 2022 to 30 Sep 2022. Updated 03 Aug 2022 |
| 04 Jul 2022 | Other trial event | According to a Biophytis media release, till now 237 patients enrollment from the France, Belgium, the United States and Brazil has been completed. Updated 08 Jul 2022 |
| 04 Jul 2022 | Results | According to a Biophytis media release, results from this study were presented 4th Annual Longevity Therapeutics Summit. Updated 08 Jul 2022 |
| 27 Jun 2022 | Other trial event | Last checked against European Clinical Trials Database record. Updated 27 Jun 2022 |
| 25 Jun 2022 | Other trial event | This trial has been completed in France (end date;2022-06-06)according to European Clinical Trials Database record. Updated 27 Jun 2022 |
| 21 May 2022 | Other trial event | This trial has been completed in Belgium according to European Clinical Trials Database record. Updated 23 May 2022 |
| 12 May 2022 | Other trial event | According to a Biophytis media release, results from this trial are expected in the third quarter of 2022. Updated 24 May 2022 |
| 07 Apr 2022 | Completion date | Planned End Date changed from 1 Dec 2021 to 1 Sep 2022. Updated 13 Apr 2022 |
| 07 Apr 2022 | Other trial event | Planned primary completion date changed from 1 Dec 2021 to 1 Jun 2022. Updated 13 Apr 2022 |
| 07 Apr 2022 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 13 Apr 2022 |
| 01 Apr 2022 | Other trial event | According to a Biophytis media release, due to the evolution of the pandemic, the company decided stop enrolment at 237 patients. Updated 08 Sep 2022 |
| 03 Feb 2022 | Other trial event | According to a Biophytis media release, based on this first approval and upcoming completion of the COVA study during H1 2022, Biophytis is willing to extend the EAP submission to other territories in the world Updated 08 Feb 2022 |
| 03 Feb 2022 | Other trial event | According to a Biophytis media release, ANVISA (Brazilian Health Authority) approved Biophytis' Expanded Access Program (EAP) for hospitalized patients with severe COVID-19 and mechanically ventilated in Intensive Care Unit.A maximum of 80 patients who are mechanically ventilated in Intensive Care Unit of Brazilian hospitals will be treated with Sarconeos (BIO101) for up to 28 daysto prevent further deterioration and mortality. Updated 08 Feb 2022 |
| 10 Nov 2021 | Completion date | Planned End Date changed from 1 Sep 2021 to 1 Dec 2021. Updated 15 Nov 2021 |
| 10 Nov 2021 | Other trial event | Planned primary completion date changed from 1 Jul 2021 to 1 Dec 2021. Updated 15 Nov 2021 |
| 15 Sep 2021 | Other trial event | According to a Biophytis media release, top line results of the study are expected in Q1 2022, depending on the evolution of the pandemic. Updated 21 Sep 2021 |
| 15 Sep 2021 | Other trial event | According to a Biophytis media release, DMC recommendation will be shared with all regulatory agencies to continue patient recruitment. 200 patients are randomized till date and 15 additional sites will be opened in USA, Brazil, France, UK and Belgium, where the COVA study is already approved. Updated 21 Sep 2021 |
| 15 Sep 2021 | Other trial event | According to a Biophytis media release, the independent Data Monitoring Committee recommended to continue Part 2 of the study without any modification after the interim efficacy data were found in the promising zone in the Interim Analysis 2 based on 155 COVID-19 patients. This recommendation completes previous safety evaluation performed by DMC last August. Updated 21 Sep 2021 |
| 16 Aug 2021 | Other trial event | According to a Biophytis media release, till date 191 patients have been randomized in 36 clinical centers opened in the USA, Brasil, France and Belgium. Updated 21 Aug 2021 |
| 30 Jun 2021 | Other trial event | According to a Biophytis media release, assuming positive data from this trial, company plans filing for Emergency Use Authorization with the FDA, and Conditional Marketing Authorization with EMA by the end of the year (Q4 2021) and if granted, commercialization could possibly start by the beginning of 2022. Updated 08 Jul 2021 |
| 30 Jun 2021 | Other trial event | According to a Biophytis Media release,176 patients have been recruited in total over the 310 required for the release of the full results. Full results from the study anticipated in Q4 2021. Updated 08 Jul 2021 |
| 30 Jun 2021 | Other trial event | According to a Biophytis Media release, data management and bio statistic activities are ongoing before submitting the results to the DMC (Data Monitoring Committee), second interim analysis are expected in Q3 2021. Updated 07 Jul 2021 |
| 12 May 2021 | Other trial event | According to a Biophytis media release, final study results are expected in Q3 2021, subject to any COVID-19-related delays and the impact of the pandemic Updated 15 May 2021 |
| 12 May 2021 | Other trial event | According to a Biophytis media release, recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants, with the aim of filing for Emergency Use Authorization with the US Food and Drug Administration (FDA) and Conditional Approval with the European Medicines Agency (EMA) in Q3 2021. Updated 15 May 2021 |
| 12 May 2021 | Other trial event | According to a Biophytis media release, the company announces that it has recruited the 155th participant for Part 2 of this study. This allows the independent Data Monitoring Committee (DMC) to conduct its second interim analysis, based on safety and efficacy data, for the continuation of the trial in case of favorable results. The Company is to report the recommendations of the DMC based on its review of the second interim analysis results by the end of Q2 2021. Updated 15 May 2021 |
| 22 Mar 2021 | Other trial event | According to a Biophytis media release, the study results (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19-related delays and the impact of the current pandemic. Updated 24 Mar 2021 |
| 22 Mar 2021 | Other trial event | According to a Biophytis media release, upon the second interim analysis, based on the safety and efficacy data from 155 patients, the DMC will re assess the total size of the cohort, estimated today at 310 patients, and the continuation of the trial. Updated 24 Mar 2021 |
| 22 Mar 2021 | Other trial event | According to a Biophytis media release, the independent Data Monitoring Committee (DMC) for the COVA study has delivered a favorable opinion on the safety of Sarconeos (BIO101) in patients infected with COVID-19, following the scheduled interim analysis of the 50 participants from Part 1 of the study, as well as the progression of patients enrollment, which has now reached 97 of the 155 planned for the second interim analysis. A total of 28 clinical centers are now opened and recruiting. Updated 24 Mar 2021 |
| 23 Feb 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 16 Feb 2021 | Other trial event | According to a Biophytis media release, results from the full study (Part 1 and Part 2) are expected in Q2 2021, subject to any delays in patient recruitment or retention, interruptions in sourcing or supply chain, regulatory authorizations and procedures, COVID-19-related delays, and the impact of the current pandemic. Updated 23 Feb 2021 |
| 16 Feb 2021 | Other trial event | According to a Biophytis media release, the company has received the regulatory authorization from the respective Regulatory Authorities in France and Belgium for part 2 study to begin patient recruitment at clinical centers. Similar regulatory authorization was obtained from Regulatory Authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and USA for most clinical centers. The trial is now recruiting for part 2 at France, Belgium, Brazil and USA. Updated 23 Feb 2021 |
| 03 Feb 2021 | Other trial event | According to a Biophytis media release, the interim analysis of Part 1 is expected in Q1 2021, subject to any COVID-19 related delays and the impact of the current pandemic on our operational capabilities. Updated 09 Feb 2021 |
| 03 Feb 2021 | Other trial event | According to a Biophytis media release, enrollment for Part 1 of the COVA Study has been completed with 50 patients recruited in 4 countries: Brazil, the USA, Belgium, and France. Following the Data Monitoring Committee (DMC) recommendation to begin the recruitment for Part 2, authorization is being obtained from regulatory authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and the USA for the start of Part 2. Updated 09 Feb 2021 |
| 03 Feb 2021 | Other trial event | According to a Biophytis media release, patient recruitment at most clinical centers in Brazil and the United States will begin for Part 2 of its COVA Study. Updated 09 Feb 2021 |
| 19 Jan 2021 | Protocol amendment | Eligibility criteria amended to include subjects from 45 years and above. Updated 27 Jan 2021 |
| 19 Jan 2021 | Other trial event | According to a Biophytis media release, results from the full study (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19 related delays and the impact of the current pandemic. Updated 21 Jan 2021 |
| 19 Jan 2021 | Other trial event | According to a Biophytis media release, the company received the recommendation by the DMC to start recruitment for Part 2 of this study. The DMC recommendation is based on its review of the safety data analysis from the first 20 patients enrolled in the study. Based on the DMC recommendation, BIOPHYTIS intends to start patient recruitment for Part 2 of this study in countries where applicable regulatory approvals, including Institutional Review Board/Ethics Committee approvals, are obtained. Updated 21 Jan 2021 |
| 11 Dec 2020 | Other trial event | According to a Biophytis media release, q total of 17 centers are now actively recruiting in Belgium, Brazil, France and the US among a targeted number of around thirty to be opened for the second part of the COVA study. Updated 18 Dec 2020 |
| 11 Dec 2020 | Other trial event | According to a Biophytis media release, In addition to the two first centers at the Pitie-Salpetriere University Hospital in Paris, Biophytis also received approval from the French National Agency for Medicines and Health Products Safety (ANSM) this month to open six new centers in France, among which Centre Hospitalier Rene Dubos and Centre Hospitalier d'Argenteuil in the Paris Region, bringing the total to eight centers planned to recruit COVID-19 patients in France. Updated 18 Dec 2020 |
| 11 Dec 2020 | Other trial event | According to a Biophytis media release, the first French patient has been dosed at La Pitie-Salpetriere University Hospital, Paris. Interim analysis and completion of full trial enrollment is expected in Q1 2021. Updated 18 Dec 2020 |
| 26 Oct 2020 | Other trial event | According to a Biophytis media release, the first patient in Brazil has been dosed at Hospital Maternidade Celso Pierro - PUCCAMP in Campinas, in this study. Updated 28 Oct 2020 |
| 13 Oct 2020 | Other trial event | According to a Biophytis media release, Dr Otis Barnum, MD, internist in Natchitoches, Louisiana is the Principal Investigator Coordinator of COVA in US. Updated 19 Oct 2020 |
| 13 Oct 2020 | Other trial event | According to a Biophytis media release, the trial has been making good progress with now seven centers open and ready to recruit COVID-19 patients in Belgium, France, Brazil and in the US. Updated 19 Oct 2020 |
| 13 Oct 2020 | Other trial event | According to a Biophytis media release, first US patient has been enrolled in this study at Natchitoches Regional Medical Center, Barnum Medical Research, in Louisiana (US). Updated 19 Oct 2020 |
| 01 Sep 2020 | Other trial event | According to a Biophytis media release, the first patient has been dosed at AZ Sint Maarten hospital in Mechelen, Belgium. The trial now has five centers ready for patients recruitment in Belgium, France and the US. Updated 04 Sep 2020 |
| 06 Aug 2020 | Other trial event | Planned number of patients changed from 310 to 465. Updated 06 Aug 2020 |
| 03 Aug 2020 | Other trial event | According to a Biophytis media release, Ludhmila Abrahaao Hajjar, MD, PhD, Professor at the Faculty of Medicine University of Sao Paulo, (InCor HCFMUSP, Sao Paulo, Brazil), is COVA's Principal Investigator and National Coordinator in Brazil. Updated 05 Aug 2020 |
| 03 Aug 2020 | Other trial event | According to a Biophytis media release, the company has received approval from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), to start its clinical development program COVA in Brazil. Updated 05 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the first part of the COVA study, which has already started in Belgium, the UK, and the USA, will provide the company with important preliminary data as the company works to confirm that Sarconeos (BIO101) can successfully prevent the deterioration of the respiratory function in Covid-19 patients. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the study is to start in France mostly with the La Pitie-Salpetriere Hospital, which is linked with Sorbonne Universitys medical school, a long-standing partner of Biophytis. The authorization comes at a crucial moment of COVID-19 upsurge in France and in Europe, re-emphazing the emergency of finding innovative treatments against the pandemics. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the second interim analysis will be conducted half way of the second part and will assess the final size of the cohort, estimated at this stage to 310 patients. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the first interim analysis will be conducted when the first 50 participants finish the study intervention period. Upon the green light to proceed, delivered by the DMC based on safety data, the Company can then continue recruiting into the second part. This analysis can also provide an initial proof of activity of Sarconeos (BIO101) on the study participants. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the COVA study is an adaptive study with 2 planned interim analyses that will be conducted by an independent data-monitoring committee (DMC). Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, this is a two-stage study that will be coordinated by Dr. Capucine Morelot-Panzini, Professor of Pulmonology at the Pitie-Salpetriere University Hospital in Paris and Principal Investigator of COVA in France. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, this phase 2/3, adaptive and seamless study is expected to start in the coming weeks in France. Updated 04 Aug 2020 |
| 27 Jul 2020 | Other trial event | According to a Biophytis media release, the company has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with its clinical development program: COVA. The program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19. Updated 04 Aug 2020 |
| 17 Jul 2020 | Other trial event | New source identified and integrated(ClinicalTrials.gov: US National Institutes of Health;NCT04472728). Updated 17 Jul 2020 |
| 13 Jul 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 04 Aug 2020 |
| 02 Jul 2020 | Other trial event | According to a Biophytis media release, the company has received 6.1 euros million private placement. The company plans to used this net proceeds for the progress of this study. Updated 07 Jul 2020 |
| 01 Jul 2020 | Other trial event | According to a Biophytis media release, the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application and received IND clearance to proceed this trial. Updated 01 Sep 2020 |
| 01 Jul 2020 | Other trial event | According to a Biophytis media release, company has already initiated the work to start this trial as soon as possible in the US, and in the European countries where approval has been received, and will update the market shortly on planned timelines. Updated 07 Jul 2020 |
| 11 Jun 2020 | Other trial event | According to a Biophytis media release, this trial is expected to start in the coming weeks in the UK, upon approval of the relevant ethics committees. Updated 12 Jun 2020 |
| 11 Jun 2020 | Other trial event | According to a Biophytis media release, the company has filed clinical trial applications with the FDA in the US. Updated 12 Jun 2020 |
| 11 Jun 2020 | Other trial event | According to a Biophytis media release, the company received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with this trial. Updated 12 Jun 2020 |
| 09 Jun 2020 | Other trial event | Planned number of patients changed from 545 to 310. Updated 09 Jun 2020 |
| 22 May 2020 | Other trial event | New source identified and integrated (European Clinical Trials Database: EudraCT2020-001498-63). Updated 22 May 2020 |
| 20 May 2020 | Other trial event | According to a Biophytis media release, the company expects to start this trial in the coming weeks in Belgium and plans to expand the trial at multiple sites in Europe and US pending potential approvals from the ANSM, MHRA and FDA. Updated 22 May 2020 |
| 20 May 2020 | Other trial event | According to a Biophytis media release, an interim analysis conducted by an independent Data Monitoring Committee (DMC) is expected in the 4th quarter of this year, subject to the evolution of the COVID-19 epidemic, will determine whether the study should progress into the second part and will allow recruitment of required sample size needed for detecting Sarconeos (BIO101) effects in part 2. Updated 22 May 2020 |
| 20 May 2020 | Other trial event | According to a Biophytis media release, Dr Muriel Lins (Pulmonologist at AZ Sint Maarten hospital in Mechelen) is the Principal Investigator of COVA in Belgium. Updated 22 May 2020 |
| 20 May 2020 | Other trial event | According to a Biophytis media release, the company has received approval from the Belgian regulatory agency, the Federal Agency for Medicines and Health Products (FAMHP), to proceed with this trial. Updated 22 May 2020 |
| 08 Apr 2020 | New trial record | New trial record Updated 08 Apr 2020 |
| 07 Apr 2020 | Other trial event | According to a Biophytis media release, it has secured a new line of financing that could reach 24 million euros, raised from Atlas, a specialized investment fund based in New York (United States) which will enable it to continue the clinical development of this trial Updated 15 Apr 2020 |
| 07 Apr 2020 | Other trial event | According to a Biophytis media release, the first randomized patient is expected to be recruited at the Pitie-Saletriere Hospital, which is linked with Sorbonne University's medical school, a long-standing partner of Biophytis. Updated 08 Apr 2020 |
| 07 Apr 2020 | Other trial event | According to a Biophytis media release, the company plan to start this trial in the coming weeks following approval from the French National Agency for the Safety of Medicines and should then extend to Belgium and the United States. Updated 08 Apr 2020 |
| 07 Apr 2020 | Other trial event | According to a Biophytis media release, the company has filed a clinical trial application with the French Regulatory Authority (ANSM). Updated 08 Apr 2020 |
Table of Contents
References
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Nair GB, Dioh W, Chabane M, Tourette C, Rabut S, Louze M, et al. Cova Results From a Double-blind, Placebo-controlled Phase 2/3 Study to Assess Efficacy and Safety of BIO101 in Hospitalized Severe COVID-19 Patients. ATS-2023 2023; abstr. N/A.
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Biophytis. BIOPHYTIS ANNOUNCES POSITIVE FINAL RESULTS OF THE PHASE 2-3 COVA STUDY WITH SARCONEOS (BIO101) IN SEVERE COVID-19. Media-Rel 2023;.
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Biophytis. Biophytis Announces Very Promising Top Line Results of its Phase 2-3 COVA Clinical Study in COVID-19-Related Respiratory Failure. Media-Rel 2022;.
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Biophytis. Biophytis Organises a Webcast with Key Opinion Leaders (KOL) On the Phase 2-3 Cova Study Results of Sarconeos (Bio101) In the Treatment of Pneumonia in Covid-19 Patients at Risk of Respiratory Failure. Media-Rel 2022;.
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Biophytis. Biophytis To Host a Combined General Shareholder's Meeting on March 30, 2023. Media-Rel 2023;.
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Biophytis. BIOPHYTIS ANNOUNCES THE POSITIVE FINAL RESULTS OF ITS COVA PHASE 2-3 STUDY WITH SARCONEOS (BIO101) IN SEVERE FORMS OF COVID-19. Media-Rel 2023;.
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Biophytis. Biophytis Enrolls First Patient in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.
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Biophytis. Biophytis Initiates the Regulatory Process for an Early Access Authorization in France from the French National Authority for Health (HAS) for the Treatment with Sarconeos (BIO101) of Severe Forms of COVID-19. Media-Rel 2023;.
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Biophytis. Biophytis Receives Approval from Brazilian Health Regulatory Agency to Start COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.
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Biophytis. Biophytis Receives Favorable Recommendation From Data Monitoring Committee (DMC) Based on Safety Analysis of Sarconeos (BIO101) to Continue Patient Recruitment in the COVA Study in COVID-19. Media-Rel 2021;.
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Biophytis. Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.
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Biophytis. BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos (BIO101) in COVID-19 allowing the 2nd Interim Analysis. Media-Rel 2021;.
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Biophytis. BIOPHYTIS ANNOUNCES THE PUBLICATION OF THE RESULTS OF ITS COVA PHASE 2-3 STUDY IN ECLINICALMEDICINE, PART OF THE LANCET. Media-Rel 2024;.
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Biophytis. Biophytis Leadership is Reinforced With New Chief Medical Officer Appointment. Media-Rel 2021;.
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Biophytis. Biophytis To Present Positive Results of Phase 2-3 COVA Study At ERS 2023 21st Lung Science Conference. Media-Rel 2023;.
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Biophytis. BIOPHYTIS ANNOUNCES ITS PARTICIPATION IN TWO MAJOR INVESTOR CONFERENCES IN JANUARY, IN THE UNITED STATES AND IN FRANCE: THE JP MORGAN HEALTHCARE CONFERENCE AND THE INVEST SECURITIES BIOMED EVENT. Media-Rel 2023;.
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Biophytis. Biophytis Announces DMC Second Interim Analysis Efficacy Results in the Promising Zone Allowing Continuation of Phase 2/3 COVA Study With Sarconeos (BIO101) in COVID-19. Media-Rel 2021;.
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Biophytis. BIOPHYTIS receives DMC recommendation for starting recruitment for Part 2 of its Phase 2-3 COVA study in COVID-19. Media-Rel 2021;.
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Biophytis. Biophytis Presented Positive Results of Phase 2-3 COVA Study At The American Thoracic Society International Conference. Media-Rel 2023;.
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Biophytis. BIOPHYTIS REPORTS THE POSITIVE POST-HOC ANALYSIS OF THE COVA PHASE 2-3 STUDY STRONGLY SUPPORTING THE THERAPEUTIC POTENTIAL OF SARCONEOS (BIO101) IN SEVERE FORMS OF COVID-19. Media-Rel 2022;.
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Biophytis. BIOPHYTIS PRESENTED SARCONEOS (BIO101) AS A POSSIBLE TREATMENT CANDIDATE FOR LONG COVID AFTER HOSPITALIZATION DURING THE 13TH ANNUAL INTERNATIONAL CONFERENCE ON FRAILTY AND SARCOPENIA RESEARCH (ICFSR). Media-Rel 2023;.
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