Regdanvimab - Celltrion
Alternative Names: CT P59; IN 006 - Celltrion/Inhalon Biopharma; IN-006; Regkirona; T-P59Latest Information Update: 22 Mar 2024
At a glance
- Originator Celltrion
- Developer Celltrion; Inhalon Biopharma
- Class Antivirals; Monoclonal antibodies
- Mechanism of Action Virus internalisation inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Registered COVID 2019 infections
Most Recent Events
- 20 Mar 2024 Pharmacokinetics and adverse events data from a phase I trial in COVID-2019 infections (In volunteers) released by Inhalon Biopharma
- 28 Aug 2023 No recent reports of development identified for phase-I development in COVID-2019-infections in United Kingdom (IV, Infusion)
- 27 Aug 2023 Inhalon Biopharma completes a phase-I trials in COVID-2019 infections (In volunteers) in United Kingdom (IV) (ISRCTN90678104)
Development Overview
Introduction
Regdanvimab (previously known as CT P59, IN 006) is a recombinant human monoclonal IgG1 antibody being developed by Celltrion, for the prevention and treatment of COVID-2019 infections. The drug binds to the receptor binding domain (RBD) of the spike protein of SARS-CoV-2. The antibody thereby inhibits the interaction between the SARS-CoV-2 RBD and the cellular receptor, the angiotensin-converting enzyme 2 (ACE2), preventing subsequent viral entry into human cells and viral replication. The drug also reduces the viral load of SARS-CoV-2 virus and inflammation in lung. The monoclonal antibody significantly neutralises the wild type and mutant variants of concern including the Alpha variant (B.1.1.7). The antibody was selected after screening a library of antibodies in the sera of a convalescent patient identified sequences of an antibody with high avidity to the receptor binding domain of the spike protein of SARS-CoV-2. Celltrion was selected as a preferred developer for the candidate by the Korea Centers for Disease Control (KCDC). Regdanvimab intravenous infusion is approved in the European union, Iceland, Liechtenstein, Norway and South Korea. Regdanvimab is approved under emergency use authorization in Brazil and Indonesia. It is provisionally approved in Australia for the treatment of mild-to-moderate and at increased risk of progressing to severe COVID-2019 infections. It is conditionally approved in Peru. Drug is under regulatory review in Canada, for the treatment of COVID-2019 infections. Clinical development is underway in Australia, the US and the UK, for the treatment of the infection and in the US and South Korea for the prevention of the infection.
A nebulised or inhaled, muco-trapping formulation of regdanvimab, designated as IN 006, is also being developed in collaboration with Inhalon by using Inhalon's muco-trapping antibody platform. The antibody platform was licensed from Johns Hopkins University and University of North Carolina at Chapel Hill. The antibody interreacts with mucin through Fc fragment to immobilise the proliferating virus in the respiratory tract, which in turn blocks the infections from further spreading locally and facilitates the rapid elimination of the pathogens from the lung through normal mucus clearance. Clinical development for the nebulised formulation is underway in the US.
A neutralising antibody cocktail with regdanvimab [see Adis Insight Drug profile 800065515] is also being developed by Celltrion for the treatment of COVID-2019 infections.
As at August 2023, no recent reports of development had been identified for phase-I development in COVID-2019-infections in United Kingdom (IV, Infusion).
Company Agreements
In July 2021, Inhalon Biopharma and Celltrion entered in an agreement to develop nebulised form of regdanivam for the treatment of COVID-2019 infections. According to the terms of the agreement, Inhalon Biopharma will utilise its muco-trapping antibody platform for the development of the drug. It will directly trap the virus in airway mucus which will prevent the local spread of the infection and eliminate the virus from the lungs through the body's natural ability to clear mucus. [1]
Key Development Milestones
Before December 2021, regdanvimab is approved conditionally in Peru [2] .
In November 2021, The European Commission (EC) granted marketing authorisation for regdanvimab. The EC granted marketing authorisation for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The decision from the EC follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the same month. The EC approval is based on the global phase III clinical trial [3] . In October 2021, Celltrion submitted the Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59) for the treatment for COVID-19 infections. The European Medicines Agency (EMA) accepted application for marketing authorisation for regdanvimab (CT-P59). The submission was supported by the positive data from the global phase III clinical trial. In March 2021, Celltrion announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for regdanvimab (CT P59) in COVID-2019 infections. The CHMP recommended that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm. Earlier in February 2021, the EMA announced that its CHMP started a rolling review of data for regdanvimab in COVID-2019 infections [4] [5] [6] [7] [8] [9] .
As of November 2021, regdanvimab is approved under emergency use authorization in Brazil and Indonesia [10] .
In September 2021, Celltrion reported that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), for the treatment for COVID-2019 infections for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition (the obese, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-2019. The Korean MFDS had granted a Conditional Marketing Authorisation (CMA) in February 2021 for the emergency use of regdanvimab (CT P59) for the treatment of COVID-2019 infections. The CMA allowed for emergency use of regdanvimab in adult patients aged 60 years and over, or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. The conditional marketing authorization was based on the data from global phase II/III trial[see below]. Celltrion reported in December 2020 that the company has submitted a conditional marketing authorisation application to the Korean MFDS for regdanvimab [11] [8] [12] [13] .
In May 2021, Celltrion completed rolling submission of regdanvimab to Health Canada for the treatment of COVID-2019 infection. The rolling submission process was recommended and accepted under the Minister of Health's interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (the ISAD IO) and transitioned to a new drug submission for COVID-19. In August 2021, Health Canada completed screening phase and granted priority review for the same [14] .
In December 2021, Therapeutic Goods Administration (TGA) of Australia granted provisional approval for the use of regdanvimab (regkirona) in adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The approval is based on the data from phase III study [see below] [2] . Earlier, in the same month, Therapeutic Goods Administration (TGA) granted provisional approval to Celltrion for the use of regdanvimab (REGKIRONA) for the treatment of COVID-19 [15] . In August 2021, Therapeutic Goods Administration (TGA) granted provisional determination to Celltrion for regdanvimab to be eligible to be considered by the TGA for treatment of mild-to-moderate COVID-19 infections in adults who are confirmed to be infected with SARS-CoV-2 [16] .
As at February 2021, Celltrion announced that it is under discussion with the US FDA for Emergency Use Authorisation (EUA) for regdanvimab for the treatment of COVID-2019 infections [8] .
In October 2020, Celltrion initiated a phase III post-exposure prophylaxis study to evaluate preventative effect and safety of regdanvimab in population-based prophylaxis in contacts of SARS-CoV-2 infected patients. The global study enrolled 1315 patients in South Korea, USA, Spain, and Romania. In June 2021, the company reported that the trial met all the primary and key secondary endpoints. This post-exposure prophylaxis clinical trial intends to evaluate the preventive effect and safety of regdanvimab and whether regdanvimab can elicit a neutralising antibody response to prevent the virus from infecting human cells. The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) in October 2020. In July 2021, Celltrion presented efficacy data of a phase III trial in COVID-2019 infections at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) [17] [18] [19] [20] .
In November 2020, Celltrion initiated a phase II/III trial to evaluate efficacy and safety of regdanvimab in combination with standard of care in hospitalised patients with COVID-2019 infections (EudraCT2020-003401-60) The randomized, double-blind trial intends to enrol approximately 700 patients in Italy and may expand to Bulgaria, France, Germany, Romania, Spain and the UK.
In October 2021, Celltrion completed a phase II/III trial that assessed the efficacy and safety of regdanvimab in combination with standard of care in outpatients with severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection (NCT04602000; EudraCT2020-003369-20). The randomised trial was initiated in September 2020 and enrolled 1642 patients in South Korea, Ireland, Hungary and Italy [8] [21] [22] . Earlier in a same month, Korean Ministry of Food and Drug Safety (MFDS) approved IND application to commence the trial. This submission was based on positive interim results of phase I trial [See below] [23] . In September 2020, Celltrion submitted IND application for phase II/III clinical study of regdanvimab for the treatment of mild-to-moderate symptoms of COVID-2019 infections in six countries including South Korea, US and Spain [23] . In January 2021, efficacy and safety results from the company were released by the Celltrion [24] .
September 2020, Celltrion initiated a global phase II/III trial in to assess the efficacy about therapeutic effect of regdanvimab to the mild to moderate SARS-CoV-2 infected patients and safety during after study drug injection (NCT04602000; EudraCT2020-003369-20) [21] . In December 2021, the efficacy and safety data were presented at annual meeting of the Infectious Diseases Society of America (IDSA) (IDWeek-2021) [25] .
As of November 2020, Celltrion initiated a global phase II trial to evaluate efficacy and safety of regdanvimab in combination with standard of care in patients with SARS-CoV-2 infection. The company also announced completion of enrollment of 327 patients in the trial. Company also intends to apply for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety based on results from the phase II trial [26] .
In August 2023, Inhalon Biopharma in collaboration with Celltrion completed a phase Ib trial that assessed the safety of IN 006 (regdanvimab for nebulization) after nebulization versus IV infusion (ISRCTN90678104; EudraCT2022-003470-23; IRAS1006745; IN-006-02). The unblinded, open-label, parallel group assignment trial was initiated in December 2022 and enrolled 48 patients in UK [27] . In March 2024, Inhalon Biopharma released pharmacokinetics and adverse events data from the trial [28] .
In October 2021, Inhalon Biopharma, in collaboration with Celltrion, initiated and dosed the first patient in a phase I trial to investigate the safety and tolerability of inhaled regdanvimab (IN 006) in healthy volunteers for the treatment of COVID-2019 infections (ACTRN12621001235897). The double-blind, placebo-controlled, dose-escalation trial intends to enroll approximately 24 healthy volunteers in Australia [29] . The study is being funded in part by a contract awarded by the US Army Medical Research & Development Command (USAMRDC) [30] .
In November 2020, Celltrion in collaboration with Chungnam National University Hospital completed a single-ascending dose phase I trial that evaluated the safety, tolerability, and pharmacokinetics of intravenously administered regdanvimab in healthy subjects (CT-P59 1.1; EudraCT2020-003065-19; NCT04525079). The randomised, double-blind, placebo-controlled, parallel trial was initiated in July 2020 and enrolled 32 healthy volunteers in South Korea. In August 2020, the company completed treatment and initial safety evaluation in the volunteers [31] [32] . In September 2020, Celltrion announced positive interim results from the trial. Results showed a promising safety, tolerability and pharmacokinetics profile of CT P59 [33] [34] .
In April 2021, Celltrion completed a single ascending dose phase I trial that investigated the safety, tolerability, virology and efficacy of regdanvimab in patients with mild symptoms of COVID-2019 infections (CT-P59 1.2; EudraCT2020-003165-19; NCT04593641). The randomised, double-blind, placebo-controlled trial initiated in September 2020, 18 patients in South Korea [35] . In July 2021, Celltrion released pharmacodynamic data of a preclinical in vivo study of regdanvimab (CT P59) in COVID-2019 infections [20] . In August 2020, Celltrion initiated a phase I trial to investigate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of regdanvimab in patients with mild symptoms of COVID-2019 infections. The trial is enrolling patients in South Korea and anticipated to expand in other countries. In similar month, the Korean Ministry of Food and Drug Safety (MFDS) approved a Investigational New Drug (IND) application to initiate the trial [31] [35] . In November 2020, company presented efficacy and safety data from the trial at the 2020 fall Conference of the Korean Society of Infectious Diseases (KSID-2020) [36] .
In July 2020, Celltrion initiated a phase I trial to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of regdanvimab in patients with mild symptoms of COVID-2019 infections in the UK. Earlier in similar month, Celltrion received approval from The UK Medicines and Healthcare products Regulatory Agency (MHRA) for the clinical trial authorization (CTA) application to initiate the trial [31] [37] [38] .
In July 2020, Celltrion announced that it has received approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure [32] .
In May 2021, Celtrion announced that in vitro and in vivo pre-clinical studies showed that regdanvimab strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the UK variant (B.1.17). Regdanvimabis successfully neutralised the SARS-CoV-2 variants first identified in California (B.1.427/B.1.429) and Brazil (P.2). The Korea Disease Control and Prevention Agency (KDCA) assessed regdanvimab with recent emerging variants first identified in New York (B.1.526), Nigeria (B.1.525) and Brazil (P.1); by infecting the host cell with this combination. Regdanvimab demonstrated strong neutralising capability against the New York (B.1.526) and Nigeria (B.1.525) variants and produced neutralising titers against the Indian variant (B.1.617) in an in-vitro pseudo virus assay [22] .
In April 2021, Celltrion released preclinical pharmacodynamics data in in vivo and in vitro model of South African variant (B.1.351). In in vivo ferret challenge studies, a therapeutic dosage of regdanvimab decreased B.1.351 viral load in the upper and lower respiratory tracts, compared with that observed for the wild type virus [17] [39] .
In February 2021, Korea Centers for Disease Control and Prevention announced that CT P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S L V G GH GR) [40] .
Before July 2020, Celltrion had demonstrated its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain (D614G variant), which is associated with the increased viral transmission and wide spread of COVID-19 [32] .
Celltrion, in conjunction with Chungbuk National University College of Medicine, released favourable preclinical data highlighting the effectiveness of its antiviral antibody in the treatment of COVID-2019 infections, in May 2020 [41] .
In April 2020, Celltrion completed the selection of potent therapeutic antibody candidates for neutralising the SARS-CoV-2 virus after screening the antibodies which exhibited the ability to bind to the virus spike protein. Out of the 38 potent neutralising antibodies, Celltrion captured 14 powerful neutralising antibodies against SARS-CoV-2. Earlier, in the same month, the company reported the initiation of the second phase of development for an antiviral treatment for COVID-2019 infections, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen [42] [43] .
Financing information
In May 2021, Inhalon Biopharma has been awarded a $US7 million contract by the US Army Medical Research & Development Command (USAMRDC) to conduct a placebo-controlled phase I/IIa study of IN 006 in COVID-2019 outpatients [44] .
Patent Information
As of May 2021, Inhalon's intellectual property includes an approved US and EU patent covering the composition of aerosolized muco-trapping antibodies [44] .
Drug Properties & Chemical Synopsis
- Route of administration Inhalation, IV
- Formulation Infusion, unspecified
- Class Antivirals, Monoclonal antibodies
- Target Coronavirus spike glycoprotein; Virus internalisation
- Mechanism of Action Virus internalisation inhibitors
-
WHO ATC code
J05A-X (Other antivirals)
-
EPhMRA code
J5B (Antivirals, excluding anti-HIV products)
- Chemical name Immunoglobulin G1, anti-(severe acute respiratory syndrome coronavirus 2 spike glycoprotein receptor-binding domain) (human monoclonal CT-P59 gamma-1 chain), disulfide with human monoclonal CT-P59 lambda-chain, dimer
- CAS Registry Number 2444308-95-4
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | provisionally approvedmild-to-moderate COVID-19 infections in adults | - | Registered | Australia | IV / Infusion | Celltrion, Inhalon Biopharma | 10 Dec 2021 |
| COVID 2019 infections | Emergency Use Authorization | - | Registered | Brazil, Indonesia | Inhalation / unspecified | Celltrion | 15 Nov 2021 |
| COVID 2019 infections | Emergency Use Authorization conditional approval | - | Registered | Brazil, Indonesia, Peru | IV / Infusion | Celltrion | 07 Dec 2021 |
| COVID 2019 infections | rolling review; 50 years of age and above Conditional Marketing Authorisation;50 years of age and above | In adults, In the elderly | Registered | European Union, Iceland, Liechtenstein, Norway, South Korea | IV / Infusion | Celltrion | 14 Nov 2021 |
| COVID 2019 infections | Rolling submission | - | Preregistration | Canada | IV / Infusion | Celltrion | 28 May 2021 |
| COVID 2019 infections | Post-exposure prophylaxis | Prevention | Phase III | South Korea, USA | IV / Infusion | Celltrion | 12 Oct 2020 |
| COVID 2019 infections | - | - | Phase II/III | USA | IV / Infusion | Celltrion | 18 May 2021 |
| COVID 2019 infections | - | In volunteers | Phase I | Australia, United Kingdom | Inhalation / unspecified | Celltrion, Inhalon Biopharma | 06 Dec 2022 |
| COVID 2019 infections | In patients with mild symptoms of COVID-19 infection | - | No development reported (I) | United Kingdom | IV / Infusion | Celltrion | 28 Aug 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Celltrion | Originator | South-Korea |
| Celltrion | Owner | South-Korea |
| John Hopkins University | Technology Provider | |
| University of North Carolina at Chapel Hill | Technology Provider | Usa |
| US Army Medical Research and Development Command | Funder | USA |
| Chungbuk National University | Collaborator | South-Korea |
| Inhalon Biopharma | Collaborator | USA |
| Korea Centers for Disease Control and Prevention | Collaborator | South-Korea |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Regkirona | Celltrion, Inhalon Biopharma | COVID 2019 infections | European Union, South Korea, United Kingdom |
Scientific Summary
Pharmacokinetics
Results from a phase Ib trial that compared the distribution and retention of regdanvimab throughout the human respiratory tract following either inhaled or intravenous (IV) delivery in healthy participants showed that 20-fold higher concentrations of antiviral antibodies were observed in the respiratory tracts of participants who received inhaled antibodies compared with those who received antibodies intravenously, despite participants with inhaled dosing receiving up to 90% less antibodies [28] [27] .
Adverse Events
Treatment with regdanvimab was safe and generally well tolerated, in patients with mild- to- moderate symptoms of COVID-2019 infections (n=1 315), in a global phase III trial. Infusion related reactions were mild and transient, with most patients recovering within 1~3 days [17] .
No serious adverse events were reported in phase II/III trial in patients with COVID-19 infections receiving regdanvimab. Overall, 0.5% of patients reported mild and transient infusion related reactions compared to 1.8% with placebo [24] [21] .
Results from the part 1 of phase II/III trial regdanvimab was safe and well-tolerated. There were no serious adverse reactions or deaths reported among the three groups. The incidence of adverse events as well as other safety assessments were generally similar among the groups [25] [21] .
Interim results from a phase I trial for COVID-2019 infections in patients with mild symptoms indicated that, regdanvimab was well tolerated in the trial. There were no significant treatment-emergent serious adverse events or clinically significant treatment-emergent adverse events identified at the interim stage [36] [35] .
Results from a phase I trial showed that regdanvimab demonstrated a reassuring safety profile in the trial. No significant drug-related adverse events were observed and importantly there were no adverse events from the maximum tolerated dose cohort [33] [34] .
Results from a phase Ib trial that compared treatment with regdanvimab, either nebulization of inhaled formulation or intravenous formulation in healthy participants showed that no drug-related adverse events were observed in the inhaled treatment cohort. Visual inspection of the participants' lungs via bronchoscopy following five days of daily inhaled treatment did not show any signs of inflammation or medication-related lung damage. Further, there were no antidrug antibodies detected in the serum of participants who received the inhaled treatments. Fewer adverse events were detected in the inhalation arms as compared to the IV arm [28] [27] .
Pharmacodynamics
Summary
Favourable preclinical data demonstrated a 100-fold reduction in the viral load of SARS-CoV-2, following administration of anti-COVID-2019 antibody, with improvement in lung lesions indicative of a restoration to normal activity level in animal models. The antibody was superior to placebo, wherein improved recovery in terms of clinical symptom scores inclusive of runny nose, cough and body aches was demonstrated by the former, following the first day of treatment. Significant clinical remission was noted, following the fifth day. High-dose group samples reflected a dip in the viral load by 100-fold. Inflammation returned to normal lung tissue histopathology within six days along with a shortened recovery time for both high and low antibody dosages, whereas sustained levels of lung inflammation and other complications were revealed for the placebo group [41] .
In preclinical study, regdanvimab demonstrated significant reduction in viral load of South African variant and no significant difference in the neutralisation titres against wild type SARS-CoV-2. Reduction in binding affinity against the receptor binding domain (RBD) in the three mutations (K417N, E484K and N501Y substitutions) of the South African variant was observed. In in vitro study, reduced susceptibility against the South African variant was observed in a live virus and pseudo-virus assay. Significant difference was not observed in the respiratory viral infection in the upper and lower respiratory tracts after exposure with SARS-CoV-2 wild type and the South African variants. In the respiratory tract, in vivo potency against the variant is unlikely to compromise due to reduced effect in in vitro neutralization of regdanvimab [39] .
Results from preclinical in vivo study demonstrated that administration of regdanvimab (CT P59) in all animals showed strong neutralising activity against the Delta variant (B.1.617.2). The study also showed 100% survival rate from COVID-19 compared to 0% for the placebo group, with significant protection against body weight loss shown after viral challenge also seen. A therapeutic dosage of regdanvimab significantly reduced the viral load of SARS-CoV-2 and inflammation in the lungs compared to non-treated controls with virus eradication from all animals treated with CT P59. The treatment with regdanvimab showed in vivo efficacy against Beta (B.1.351), Lambda (C.37) and Gamma variant (P.1) [20]
Therapeutic Trials
Interim results from a phase I trial for the treatment of COVID-2019 infections with mild symptoms demonstrated that, the patient population treated with regdanvimab experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. None of the patients treated with regdanvimab required hospitalisation or antiviral therapy as a result of COVID 2019. The recorded from 18 patients with mild symptoms of SARS-COV-2 infection [36] [35] .
The results from the part 1 of phase II/III trial demonstrated that there was a significant decrease in hospitalizations and oxygen supplementation with regdanvimab in patients at high risk of progressing to severe COVID-19. Regdanvimab 40 mg showed a 66.1% reduction in event rate among patients who met the high-risk criteria. Additionally, regdanvimab groups showed greater reductions in viral load from baseline [25] [21] .
Results from phase II/III trial in patients with COVID-19 infections demonstrated reduction in progression rate and in time to clinical recovery, post treatment with regdanvimab. Treatment with regdanvimab showed reduction in progression rate by 54% for patients with mild to moderate symptoms with 68% reduction in progression in patients aged over 50 years and above. Reduction in time of clinical recovery was observed to 3.4 days in patients treated with CT-P59 at 40mg/kg compared to 6.4 days for placebo. Patients treated with regdanvimab at 40mg/kg recovered 3.4 days earlier than those in the placebo group [5.4 vs. 8.8 days; 95% C.I, 5.35(3.97, 6.78) to 8.77 (6.72, 11.73), log-rank p-value= 0.0097]. Treatment with regdanvimab in patients with pneumonia reported shortened recovery time by 5.1 days compared to placebo [5.7 vs. 10.8 days; 95% C.I, 5.73 (4.13, 7.33) to 10.81 (6.81, N.C.)]. Moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo [6.6 vs. 13.0 days; 95% C.I, 6.64 (4.13, 11.94) to 12.97 (6.81, N.C.)]. Administration of regdanvimab reduced viral load at day 7 compared to placebo [24] [21] .
Results showed that regdanvimab significantly reduced the risk of hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 up to day 28, compared with placebo, meeting the primary efficacy endpoint [3.1 vs. 11.1 %, p-value< 0.0001], in patients with mild- to- moderate symptoms of COVID-2019 infections (n=1 315), in a global phase III trial. Regdanvimab also significantly reduced the risk of hospitalisation or death by 70% in all patients, meeting the first key secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001]. The trial also met the other key secondary endpoints, including faster and persistent reduction in symptom duration. Patients treated with regdanvimab (40mg/kg) recovered at least 4.7 days earlier than those in the placebo-treated patients [median 9.3 vs. minimum 14 days, p-value< 0.0001] for patients at high- risk of progressing to severe COVID-19. For all patients treated with regdanvimab (40mg/kg), patients recovered 4.9 days earlier than those in the placebo-treated patients [median 8.4 vs. 13.3 days, p-value< 0.0001]. No clinically meaningful differences between patients treated with CT-P59 (40mg/kg) and placebo-treated patients [17] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Aug 2021 | Trial Update | Inhalon Biopharma plans a phase I/II trial for COVID-2019 infections following productive discussions with the FDA in summer of 2021 [44] | 02 Aug 2021 |
| 31 Dec 2020 | Trial Update | Celltrion plans a phase II/III trials in COVID-2019 infections by the end of 2020 at multiple locations including Korea (IV) (700325225) [31] | 30 Nov 2020 |
| 31 Dec 2020 | Trial Update | Celltrion plans a clinical trial for COVID-2019 infections (Prevention) by the end of 2020 (IV) (700325227) [31] | 14 Oct 2020 |
| 31 Dec 2020 | Trial Update | Celltrion plans a phase III trials COVID-2019 infections at multiple locations including Korea by the end of 2020 (IV) (700327088) [31] | 15 Sep 2020 |
| 01 Jul 2020 | Trial Update | Celltrion plans a clinical trial for COVID-2019 infections in July 2020 (700320129) [43] | 28 Jul 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 20 Mar 2024 | Scientific Update | Pharmacokinetics and adverse events data from a phase I trial in COVID-2019 infections (In volunteers) released by Inhalon Biopharma [28] Updated 22 Mar 2024 |
| 28 Aug 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections in United Kingdom (IV, Infusion) Updated 28 Aug 2023 |
| 27 Aug 2023 | Trial Update | Inhalon Biopharma completes a phase-I trials in COVID-2019 infections (In volunteers) in United Kingdom (IV) (ISRCTN90678104) Updated 06 Sep 2023 |
| 06 Dec 2022 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in United Kingdom (Inhalation) (ISRCTN90678104) Updated 24 May 2023 |
| 06 Dec 2022 | Trial Update | Inhalon Biopharma initiates a phase-I trials in COVID-2019 infections (In volunteers) in United Kingdom (IV) (ISRCTN90678104) Updated 24 May 2023 |
| 08 Apr 2022 | Trial Update | Celltrion completes a phase I trial in COVID 19 infections in South korea (NCT04593641) Updated 21 Apr 2022 |
| 10 Dec 2021 | Phase Change - Registered | Registered for COVID-2019 infections (mild to moderate) in Australia (IV)- provisional approval in December 2021 [15] Updated 10 Dec 2021 |
| 07 Dec 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Peru (IV)-conditional approval before December 2021 [2] Updated 10 Dec 2021 |
| 07 Dec 2021 | Regulatory Status | TGA approves regdanvimab for treatment of increased risk of progressing to severe COVID-19 infections in Australia in December 2021 [2] Updated 10 Dec 2021 |
| 04 Dec 2021 | Scientific Update | Efficacy and adverse events data from a phase II/III trial in COVID-2019 infections presented at the Infectious Diseases Society of America Week (IDWeek-2021) [25] Updated 08 Feb 2022 |
| 15 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Brazil (Inhalation) [10] Updated 01 Dec 2021 |
| 15 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Brazil (IV) [10] Updated 01 Dec 2021 |
| 15 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Indonesia (Inhalation) [10] Updated 01 Dec 2021 |
| 15 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Indonesia (IV) [10] Updated 01 Dec 2021 |
| 14 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In the elderly, In adults) in European Union (IV) [3] Updated 16 Nov 2021 |
| 14 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In the elderly, In adults) in Norway (IV) [3] Updated 16 Nov 2021 |
| 14 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In the elderly, In adults) in Iceland (IV) [3] Updated 16 Nov 2021 |
| 14 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In the elderly, In adults) in Liechtenstein (IV) [3] Updated 16 Nov 2021 |
| 20 Oct 2021 | Trial Update | Celltrion completes a phase-II/III trials in COVID-2019 infections in Hungary, South Korea, Italy and Ireland (IV) (EudraCT2020-003369-20) (NCT04602000) Updated 07 Dec 2021 |
| 13 Oct 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in Australia (IV) (ACTRN12621001235897) Updated 22 Oct 2021 |
| 07 Oct 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in Australia (Inhalation) (ACTRN12621001235897) [30] Updated 12 Oct 2021 |
| 05 Oct 2021 | Regulatory Status | The European Medicines Agency (EMA) accepts MAA for regdanvimab for Covid-19 infections in European Union [9] Updated 06 Oct 2021 |
| 18 Sep 2021 | Regulatory Status | The Korean Ministry of Food and Drug Safety (MFDS) approves (full approval) regdanvimab for COVID-2019 infections (In adults, In the elderly) in South Korea - First global approval [11] [13] Updated 21 Sep 2021 |
| 15 Sep 2021 | Trial Update | Inhalon Biopharma plans a phase I trial in COVID-2019 infections (In volunteers) in Australia in September 2021 (ACTRN12621001235897) Updated 15 Sep 2021 |
| 23 Aug 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (mild to moderate) in Australia (IV)-provisional determination in August 2021 [16] Updated 10 Dec 2021 |
| 23 Aug 2021 | Regulatory Status | Celltrion plans to file Provisional registration with the Therapeutic Goods Administration for COVID-2019 infections [16] Updated 26 Aug 2021 |
| 20 Aug 2021 | Regulatory Status | Therapeutic Goods Administration grants Provisional determination for regdanvimab for COVID-2019 infections [16] Updated 26 Aug 2021 |
| 02 Aug 2021 | Regulatory Status | Regdanvimab receives priority review status for COVID-19 infections in Canada [14] Updated 03 Aug 2021 |
| 22 Jul 2021 | Licensing Status | Celltrion and Inhalon Biopharma enters in an agreement to co-develop nebulised form of regdanvimab [1] Updated 02 Aug 2021 |
| 19 Jul 2021 | Scientific Update | Pharmacodynamic data from preclinical studies in COVID-2019 infections released [20] Updated 19 Jul 2021 |
| 14 Jun 2021 | Scientific Update | Safety and efficacy data from a phase III trial in COVID-2019 infections released by Celltrion [17] Updated 20 Jun 2021 |
| 28 May 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections in Canada (IV) [14] Updated 03 Aug 2021 |
| 26 May 2021 | Licensing Status | Inhalon Biopharma in-licenses muco-trapping technology from John Hopkins University and University of North Carolina at Chapel Hill before May 2021 [44] Updated 02 Aug 2021 |
| 26 May 2021 | Company Involvement | Inhalon Biopharma receives an award from US Army Medical Research & Development Command (USAMRDC) to conduct phase I/II trial for IN 006 in COVID-2019 infections [44] Updated 02 Aug 2021 |
| 26 May 2021 | Patent Information | Inhalon Biopharma has patent protection for composition of aerosolized muco-trapping antibodies in USA and European Union [44] Updated 02 Aug 2021 |
| 26 May 2021 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (Inhalation) [44] Updated 02 Aug 2021 |
| 26 May 2021 | Trial Update | Inhalon Biopharma plans a phase I/II trial for COVID-2019 infections following productive discussions with the FDA in summer of 2021 [44] Updated 02 Aug 2021 |
| 18 May 2021 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in USA, Spain, Romania (IV) before May 2021 [22] (EudraCT2020-003369-20) Updated 23 May 2021 |
| 29 Apr 2021 | Scientific Update | Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by Celltrion [39] Updated 05 May 2021 |
| 26 Mar 2021 | Regulatory Status | The EMA's Committee for Medicinal Products for Human Use (CHMP) recommends approval of regdanvimab for COVID-2019 infections in European Union [5] Updated 31 Mar 2021 |
| 24 Feb 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adults, In the elderly) in European Union (IV) [6] Updated 04 Mar 2021 |
| 24 Feb 2021 | Regulatory Status | The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) initiates rolling review for regdanvimab in COVID-2019 infections in the European Union [6] Updated 04 Mar 2021 |
| 05 Feb 2021 | Phase Change - Registered | Registered (Emergency use authorisation) for COVID-2019 infections (In adults, In the elderly) in South Korea (IV) - Conditional marketing authorisation [8] Updated 09 Feb 2021 |
| 13 Jan 2021 | Scientific Update | Efficacy and adverse events data from a phase II/III trial in COVID-2019 infections released by Celltrion [24] Updated 15 Jan 2021 |
| 29 Dec 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adults, In the elderly) in South Korea (IV) [12] Updated 31 Dec 2020 |
| 29 Dec 2020 | Regulatory Status | Celltrion files Conditional Marketing Authorisation (CMA) application to the Ministry of Food and Drug Safety (MFDS) for treatment of patients with COVID-2019 infections in South Korea [12] Updated 31 Dec 2020 |
| 29 Dec 2020 | Regulatory Status | Celltrion plans to file Conditional Marketing Authorisation (CMA) application to the European Medicines Agency (EMA) for treatment of patients with COVID-2019 infections in European Union [12] [8] Updated 31 Dec 2020 |
| 29 Dec 2020 | Regulatory Status | Celltrion plans to file Emergency Use Authorisation (EUA) application to the US FDA for treatment of patients with COVID-2019 infections in the US [12] [8] Updated 31 Dec 2020 |
| 30 Nov 2020 | Regulatory Status | Celltrion intends to apply for emergency use authorisation (EUA) for COVID-2019 infections to the Korean Ministry of Food and Drug Safety [26] Updated 30 Nov 2020 |
| 25 Nov 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections in South Korea (IV) prior to November 2020 [26] Updated 30 Nov 2020 |
| 25 Nov 2020 | Trial Update | Celltrion completes enrolment in its global phase II trial for COVID-2019 infections in South Korea [26] Updated 30 Nov 2020 |
| 23 Nov 2020 | Trial Update | Celltrion initiates a phase-II/III clinical trials in COVID-2019 infections in Italy (IV) (EudraCT2020-003369-20) Updated 15 Jan 2021 |
| 19 Nov 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in Italy (IV) (EudraCT2020-003401-60) Updated 24 Dec 2020 |
| 13 Nov 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in Ireland (IV) (EudraCT2020-003369-20) Updated 23 May 2021 |
| 13 Nov 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in Hungary (IV), after November 2020 (EudraCT2020-003369-20) (NCT04602000) Updated 09 Feb 2021 |
| 10 Nov 2020 | Scientific Update | Efficacy and adverse events data from a phase I trial in COVID-2019 infections with mild symptoms presented at the 2020 fall Conference of the Korean Society of Infectious Diseases (KSID-2020) [36] Updated 10 Nov 2020 |
| 05 Nov 2020 | Trial Update | Celltrion completes a phase-I clinical trial in Healthy volunteers in South Korea (NCT04525079) Updated 02 Dec 2021 |
| 12 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in USA (IV) [9] Updated 06 Oct 2021 |
| 12 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in South Korea (IV) [18] Updated 14 Oct 2020 |
| 25 Sep 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in South Korea (IV) (NCT04602000) Updated 30 Nov 2020 |
| 17 Sep 2020 | Regulatory Status | Celltrion has filed IND applications in six countries including Korea, US and Spain for COVID-2019 infections [23] Updated 18 Sep 2020 |
| 17 Sep 2020 | Regulatory Status | Korean Ministry of Food and Drug Safety approves IND application for CT P59 in COVID-2019 infections [23] Updated 18 Sep 2020 |
| 14 Sep 2020 | Scientific Update | Adverse events data from a phase I trial in COVID-2019 infections released by Celltrion [33] Updated 15 Sep 2020 |
| 04 Sep 2020 | Trial Update | Celltrion initiates a phase I trial in COVID-2019 infections in South Korea (IV) (NCT04593641) Updated 26 Oct 2020 |
| 27 Aug 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections in South Korea (IV) [31] Updated 28 Aug 2020 |
| 27 Aug 2020 | Regulatory Status | The Korean Ministry of Food and Drug Safety approves IND application of CT P59 in COVID-2019 infections [31] Updated 28 Aug 2020 |
| 26 Aug 2020 | Trial Update | Celltrion plans a phase II/III trials in COVID-2019 infections by the end of 2020 at multiple locations including Korea (IV) [31] Updated 30 Nov 2020 |
| 26 Aug 2020 | Trial Update | Celltrion plans a clinical trial for COVID-2019 infections (Prevention) by the end of 2020 (IV) [31] Updated 14 Oct 2020 |
| 26 Aug 2020 | Trial Update | Celltrion plans a phase III trials COVID-2019 infections at multiple locations including Korea by the end of 2020 (IV) [31] Updated 15 Sep 2020 |
| 30 Jul 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections in United Kingdom (IV) [31] Updated 28 Aug 2020 |
| 30 Jul 2020 | Regulatory Status | The UK Medicines and Healthcare products Regulatory Agency (MHRA) approves CTA for CT P59 in COVID-2019 infections [37] Updated 03 Aug 2020 |
| 30 Jul 2020 | Trial Update | Celltrion plans a phase I trial for COVID-2019 infections in the UK [37] Updated 03 Aug 2020 |
| 17 Jul 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in South Korea (IV) [32] Updated 21 Jul 2020 |
| 17 Jul 2020 | Regulatory Status | The Korean Ministry of Food and Drug Safety (MFDS) approves Investigational New Drug application for CT P59 in COVID-2019 infections before July 2020 [32] Updated 21 Jul 2020 |
| 17 Jul 2020 | Trial Update | Celltrion plans a clinical trial in COVID-2019 infections (Prevention) in world (Parenteral) [32] Updated 21 Jul 2020 |
| 17 Jul 2020 | Trial Update | Celltrion plans a phase I clinical trial in COVID-2019 infections in Europe, including the UK (Parenteral) [32] Updated 21 Jul 2020 |
| 17 Jul 2020 | Trial Update | Celltrion plans phase II/III clinical trials in COVID-2019 infections in world (Parenteral) [32] [37] Updated 21 Jul 2020 |
| 16 Jul 2020 | Regulatory Status | Celltrion submits Investigational New Drug application to the Korean Ministry of Food and Drug Safety (MFDS) in South Korea for COVID-2019 infections before July 2020 [32] Updated 21 Jul 2020 |
| 31 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in South Korea (Parenteral) before May 2020 [41] Updated 04 Jun 2020 |
| 31 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in South Korea (Parenteral) before May 2020 [41] Updated 04 Jun 2020 |
| 31 May 2020 | Scientific Update | Positive pharmacodynamics data from a preclinical study in COVID-2019 infections released by Celltrion [41] Updated 04 Jun 2020 |
| 31 May 2020 | Trial Update | Celltrion plans additional preclinical efficacy and toxicity studies in COVID-2019 infections (Parenteral) [41] Updated 04 Jun 2020 |
| 03 Apr 2020 | Trial Update | Celltrion plans a clinical trial for COVID-2019 infections in July 2020 [43] Updated 28 Jul 2020 |
| 01 Apr 2020 | Active Status Review | Peer QC and QC feedback incorporated, MOA modified to Immunostimulants Updated 01 Apr 2020 |
| 26 Mar 2020 | Licensing Status | CT P59 is available for licensing as of 26 Mar 2020. http://www.celltrion.com/ko-kr/home/index (Celltrion website, March 2020) Updated 21 Jul 2020 |
| 23 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in South Korea (Parenteral) [45] Updated 01 Apr 2020 |
| 23 Mar 2020 | Phase Change | Early research in COVID-2019 infections in South Korea (Parenteral) [45] Updated 26 Mar 2020 |
References
-
Inhalon Collaborates with Celltrion, Inc. to Develop Nebulized Form of Regdanvimab to Treat COVID-19 Patients at Home.
Media Release -
TGA grants provisional approval for Celltrion's regdanvimab (regkirona).
Media Release -
Celltrions Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19.
Media Release -
CT-P59 or regdanvimab. Internet-Doc 2021;.
Available from: URL: https://www.ema.europa.eu/en/documents/referral/regdanvimab-treatment-covid-19-celltrion-covid-19-article-53-procedure-assessment-report_en.pdf -
EMA issues advice on the use of Celltrions anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union.
Media Release -
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19.
Media Release -
EMA issues advice on use of regdanvimab for treating COVID-19 .
Media Release -
Celltrions COVID-19 Treatment Candidate Receives Korean MFDS Conditional Marketing Authorisation.
Media Release -
Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59).
Media Release -
Celltrion's Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19.
Media Release -
Celltrions monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS).
Media Release -
Celltrion Submits Application for Conditional Marketing Authorisation of Its COVID-19 Treatment Candidate CT-P59 to the Korean MFDS.
Media Release -
Celltrion's regdanvimab (CT-P59) becomes the first authorized COVID-19 treatment approved from the Korean MFDS.
Media Release -
Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59).
Media Release -
TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (REGKIRONA).
Media Release -
TGA grants provisional determination to Celltrion Healthcare Australia Pty Ltd's antiviral COVID-19 treatment regdanvimab.
Media Release -
Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment.
Media Release -
Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59.
Media Release -
A Post-Exposure Prophylaxis Phase III Clinical Trial to Evaluate Protective Efficacy of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate (CT-P59) in Contacts of SARS-CoV-2 Infected Patients
ctiprofile -
Celltrions Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant.
Media Release -
A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection
ctiprofile -
Celltrion Confirms Neutralising Potency Against Emerging SARS-CoV-2 Variants With Anti-COVID-19 Monoclonal Antibody Treatment regdanvimab (CT-P59).
Media Release -
Celltrion receives Korean MFDS approval to initiate Phase II/III pivotal trial of an anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.
Media Release -
Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59.
Media Release -
Ison MG, Kim JY, Sandulescu O, Preotescu L-L, Martinez NER, Dobryanska M, et al. Therapeutic Effect of Regdanvimab in Patients with Mild to Moderate COVID-19: Day 28 Results from a Multicentre, Randomised, Controlled Pivotal Trial. IDW-2021 2021; abstr. 546.
Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S375/6450285 -
Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P59.
Media Release -
A phase Ib, open-label, pharmacokinetics and safety study of IN-006 (regdanvimab for nebulization) versus intravenous regdanvimab in healthy volunteers
ctiprofile -
Inhalon Biopharma Announces Positive Results from Study Demonstrating Superior Safety and Efficacy of its Inhaled Antibody Platform Over Systemic Dosing.
Media Release -
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of Nebulized IN-006 in Healthy Volunteers
ctiprofile -
Inhalon Doses First Patient in Phase 1 Study of Inhaled IN-006 to Treat COVID-19.
Media Release -
Celltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients.
Media Release -
Celltrion Launches Human Clinical Trial of Potential COVID-19 Antiviral Antibody Treatment Following Positive Pre-Clinical Results.
Media Release -
Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate.
Media Release -
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
ctiprofile -
A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection
ctiprofile -
Celltrion presents efficacy and safety data for potential COVID-19 treatment candidate CT-P59 in patients with mild symptoms.
Media Release -
Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK.
Media Release -
A Phase 1 clinical trial of CT P59 (anti-viral monoclonal antibody) in mild COVID-19 patients
ctiprofile -
Celltrions anti-COVID 19 monoclonal antibody treatment, regdanvimab (CT-P59), demonstrates neutralising effect against the South African variant (B.1.351).
Media Release -
Celltrion Develops Tailored Neutralising Antibody Cocktail Treatment with CT-P59 to Tackle COVID-19 Variant Spread Using Its Antibody Development Platform.
Media Release -
Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time.
Media Release -
Celltrion Completes Neutralisation Test on Candidate Monoclonal Antibodies (mAbs) for COVID-19 Antiviral Antibody Treatment.
Media Release -
Celltrions COVID-19 Antiviral Treatment Enters the Next Phase of Development.
Media Release -
Inhalon Biopharma Receives $7 Million from USAMRDC to Study Inhaled Muco-trapping Antibody for the Treatment of COVID-19.
Media Release -
Celltrion Accelerates Development of COVID-19 Antiviral Treatment and Aims to Launch Rapid Self-testing Kit.
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG