Galidesivir - BioCryst Pharmaceuticals
Alternative Names: BCX-4430Latest Information Update: 01 Mar 2023
At a glance
- Originator Albert Einstein College of Medicine; BioCryst Pharmaceuticals; Victoria University of Wellington
- Developer BioCryst Pharmaceuticals; National Institute of Allergy and Infectious Diseases; Utah State University
- Class Antivirals; Purine nucleosides; Pyrimidine nucleosides; Pyrroles; Pyrrolidines; Small molecules
- Mechanism of Action RNA replicase 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
- Discontinued COVID 2019 infections; Ebola virus infections; Marburg virus disease; Middle East respiratory syndrome coronavirus; Yellow fever; Zika virus infection
Most Recent Events
Development Overview
Introduction
Galidesivir is a RNA replicase inhibitor, was being developed by BioCryst Pharmaceuticals, for the treatment of haemorrhagic fevers, including yellow fever, Marburg virus, Ebola virus and Zika virus infections. RNA polymerase plays a crucial role in viral replication process; transcription and replication of the virus genome. Galidesivir is metabolised to the active triphosphate (nucleotide) form by cellular kinases and it then binds to the viral enzyme active site and becomes incorporated into the growing viral RNA strand, leading to premature chain termination.The product an adenosine analogue, demonstrates broad-spectrum antiviral activity against more than 20 ribonucleic acid (RNA) viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses. metabolized to the active triphosphate (nucleotide) form by cellular kinases. The drug has also demonstrated efficacy against the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infections. BioCryst intends to seek approval of galidesivir via the Animal Rule regulatory pathway for Marburg and Ebola viral diseases. Clinical development for intravenous formulation of galidesivir for the treatment of yellow fever and COVID-2019 infections was underway in the US and Brazil respectively. Preclinical and early-stage clinical development for intravenous and intramucular formulation of galidesivir, for Ebola virus infections, Marburg virus disease was underway in the US and the UK. However, after the expiry of government funding in 2022, the company reported that it has no plans to continue the galidesivir program without government funding.
Galidesivir emerged from the company's research programme on viral RNA polymerase inhibitors [see AdisInsight drug profile 800016143].
Company Agreements
In June 2012, BioCryst pharmaceutical entered into licensing agreement with Albert Einstein College of Medicine and Ferrier Research Institute of Victoria University to initiate clinical trials for galidesivir. [1]
In March 2015, BioCryst Pharmaceuticals was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS), valued at up to $US35 million, for the continued development of galidesivir as a broad spectrum antiviral drug for the treatment of diseases caused by RNA pathogens, including filoviruses. Under the terms of the contract, BARDA/HHS will provide a base contract of $US12.1 million to support manufacturing of galidesivir and $US22.9 million for additional development options to be exercised [2] .
Key Development Milestones
In February 2023, BioCryst Pharmaceuticals reported that the government funding for galidesivir expired in 2022, and the company have no plans to continue the galidesivir program without government funding [3] .
In May 2021, BioCryst Pharmaceuticals terminated a phase Ib trial due to their decision to no longer pursue indications studied in this trial (NCT03891420; BCX4430-108; DMID18-0022). The randomised, double-blind, placebo-controlled trial was initiated in April 2020 to evaluate the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19 infections. The trial enrolled 24 patients in Brazil. The trial protocol is approved by the Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee (CONEP). Part 1 of the trial will enroll 24 hospitalized adults diagnosed with moderate to severe COVID-19. In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive intravenous galidesivir or placebo [4] [5] . In November 2020, the patients enrollments were completed in the trial [6] . In December 2020, BioCryst Pharmaceuticals released results form the part 1 of the trial. The company reported that, trial was not designed or sized to demonstrate clinical efficacy, and no clinical efficacy benefit with galidesivir treatment compared to placebo treatment was observed in the trial [1] [7] [8] .
As of March 2020, phase II development of galidesivir was underway for the treatment of yellow fever under contract with the National Institute of Allergy and Infectious Diseases (NIAID) and the US Department of Health and Human Services (HHS) [9] .
In May 2019, BioCryst Pharmaceuticals completed a phase I trial that evaluated the safety, tolerability and pharmacokinetics of escalating doses of galidesivir, following administration of single doses (5mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg) by intravenous infusion, in healthy volunteers (NCT03800173; BCX4430-106; DMID18-0013; 272201300017C-18-0-1). The randomised, placebo-controlled, double-blind trial was initiated in December 2018, and enrolled 24 participants in the US. Earlier, in January 2019, the first patient was dosed. In May 2019, the company reported that the trial outcome was successful. During the trial, galidesivir was generally safe and well tolerated [10] [11] [12] [13] .
In May 2016, BioCryst reported that it has completed a phase I trial which investigated the safety, tolerability and pharmacokinetics of escalating doses of galidesivir in healthy volunteers (BCX4430-101, DMID 14-0030; NCT02319772). The trial was initiated in December 2014, and enrolled 94 participants in the UK. In part 1, volunteers received a single dose of galidesivir (up to six cohorts) and in part 2, volunteers received galidesivir for 7 days (four cohorts). The trial was funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health in the US. Galidesivir was generally safe and well tolerated through doses up to 10 mg/kg daily for seven days [14] [15] [16] .
BioCryst, in October 2017, reported positive data from a preclinical study of intramuscular galidesivir in rhesus macaques models of zika virus infection and ebola virus infection. The data was also presented at the IDWeek 2016 (IDW - 2017) [17] .
In August 2017, BioCryst announced that it will conduct an additional non-clinical efficacy study in a delayed treatment setting in Ebola virus infections before finalising the protocol for a phase I trial, based on discussions with the FDA, BARDA and NIAID [18] .
BioCryst Pharmaceuticals, in September 2016, released favourable data from a 28-day proof of concept study that evaluated galidesivir for the delayed treatment of Ebola virus infections in NHP models [19] .
In November 2014, BioCryst initiated non-human primate studies (NHP) to evaluate the efficacy of galidesivir against Ebola virus in NHP disease models. The company also reported that a dose-ranging study was conducted in cynomolgus macaques infected with Ebola. In December 2014, the company reported results from a proof-of-concept study in rhesus macaques infected with Ebola. The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and was conducted at the United States Army Medical Research Institute of Infectious Diseases [20] .
BioCryst, in October 2016, reported data from a preclinical study that demonstrated favourable efficacy and safety of intramuscular galidesivir in rhesus monkeys infected with Zika virus [21] . The data was also presented at the IDWeek 2016 (IDW - 2016) [22] .
In May 2016, BioCryst reported that in collaboration with Utah State University and NIAID, preclinical development of galidesivir in a model of Zika virus infection in interferon-receptor-deficient mice is underway in the US. Studies showed improved survival with dosing delayed up to 7 days after virus challenge, reduction in viral titer in the blood and development of protective immunity in surviving animals [14] .
BioCryst has identified galidesivir as a lead candidate for the treatment of yellow fever, under the NIAID Animal Models of Infectious Disease Program. In November 2012, the company announced positive proof-of-principle pharmacodynamics data for galidesivir [23] [24] . It has been shown to be active against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses [25] .
BioCryst reported in September 2013 that galidesivir is also being developed for the treatment of Marburg virus disease in addition to Ebola, under a contract with the NIAID. In December 2013, the NIAID exercised an option to conduct the IND enabling programme and ultimately conduct a phase I trial of intravenous and intramuscular formulations of galidesivir. BioCryst received a total of $US7.5 million; the award could total up to $US22 million over 5 years [26] [27] .
In February 2014, BioCryst announced the publication of preclinical efficacy results for galidesivir, in animal models of Marburg virus and Ebola virus infection, in the journal Nature. The publication represents the first report of protection from filovirus disease in non-human primates by a small molecule drug. In cynomolgus macaques, the administration of galidesivir by intramuscular injection resulted in complete protection from Marburg virus, 48-hours post-infection. Protection against Marburg virus and Ebola virus infections was also demonstrated in rodents. In addition, galidesivir has shown potential in vitro against a broad range of other RNA viruses, including the emerging Middle East Respiratory Syndrome Coronavirus (MERS-CoV) [25] .
In December 2012, BioCryst announced the company's strategic restructuring with focus on development of antiviral programmes, including the broad spectrum antiviral, galidesivir, and BCX 5191 for HCV [24] .
Financing information
In November 2019, BioCryst Pharmaceuticals announced the completion of the underwritten public offering of 43,620,690 shares of its common stock. The net proceeds from the offering will be use for general corporate purposes, that may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic berotralstat program, primarily focusing on the U.S., EU and Japan; development of the BCX 9930 program; development of the BCX 9250 program; post-approval commitments for RAPIVAB®/ALPIVABTM; [see ADIS insight drug profiles800042435, 800040653 , 800056474, 800010752, respectively] funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses [28] .
In August 2020, the National Institute of Allergy and Infectious Diseases (NIAID), awarded BioCryst a new contract 75N93020C00055 totalling of $US44 million and added an award of approximately $US3 million to its existing contract HHSN272201300017C, to support the development of galidesivir [29] . In December 2020, BioCryst Pharmaceuticals reported that, they expect NIAID/HHS to continue its support for the development of galidesivir with a focus on biodefense threats, such as Marburg virus disease, and to discontinue the pursuit of a COVID-19 indication for galidesivir [1] . In September 2018, National Institute of Allergy and Infectious Diseases (NIAID) granted BioCryst an additional funding of $US3.5 million to support clinical trials of galidesivir in patients with yellow fever. The additional funding brings the NIAID contract amount to $US43.0 million. The NIAID, in July 2016, awarded an additional funding worth $US5.5 million, to support the development of galidesivir for the treatment of haemorrhagic fever viruses. In September 2013, the NIAID had awarded a contract to BioCryst Pharmaceuticals, for the development of galidesivir for the treatment of Marburg virus disease and other filoviruses, including Ebola virus disease. The funding of up to $US26.3 million over five years, if all options are exercised, will support early stage development of galidesivir, including non-human primate proof-of-concept studies, as well as a phase I study in healthy subjects [30] [19] [31] .
In June 2014, BioCryst was awarded an option funding to conduct development of an IV formulation of galidesivir including, pre-formulation, stability studies and manufacture of the drug candidate, under this contract. NIAID exercised two additional options valued at $US4.1 million, under this contract in August 2014, during the time of the Ebola epidemic in West Africa. These funds will enable BioCryst to conduct efficacy studies of galidesivir in non-human primates, file an IND and conduct phase I safety trials of an intramuscular formulation of galidesivir. Later, in the same month, under the contract modification, the company was awarded with an additional $US2.4 million funds from NIAID for carrying out dose ranging efficacy study of galidesivir (IM) in non-human primates as a treatment for Ebola virus infection. BioCryst received $US4 million in September 2014, when NIAID exercised two more options, which allows for the GMP manufacturing of drug product of galidesivir. Exercising of these options increased the existing contract value by $US2 million; the grant amount revised to $US26.3 million. In November 2014, BioCryst announced that the NIAID has increased the contract value to $US28.7 million, the company also reported that it was awarded $US2.4 million in October 2014, to conduct second NHP study. An additional option was exercised by NIAID in February 2015 that provided the company with an additional $US2.7 million for submission of an IND application for intravenous galidesivir. The total funds awarded to date under the NIAID contract amounts to $US25.0 million, as at February 2015, with a potential total amount of $US29.1 million. Since March 2015, BARDA supported the continued development of galidesivir, under contract HHSO100201500007C, for the treatment for filoviruses. The total contract value to advance the program through toxicology studies and manufacturing work to support a new drug application is $US39.1 million, if all contract options are exercised [31] [32] [33] [34] [35] [36] .
Drug Properties & Chemical Synopsis
- Route of administration IM, IV, PO
- Formulation Infusion, Injection, unspecified
- Class Antivirals, Purine nucleosides, Pyrimidine nucleosides, Pyrroles, Pyrrolidines, Small molecules
- Target RNA replicase
- Mechanism of Action RNA replicase inhibitors
-
WHO ATC code
J05A (Direct acting antivirals)
-
EPhMRA code
J5B (Antivirals, excluding anti-HIV products)
- Chemical name 2S,3S,4R,5R)-2-(4-amino-5H-pyrrolo[3,2-d]pyrimidin-7-yl)-5-(hydroxymethyl)pyrrolidine-3,4-diol
- Molecular formula C11-H15-N5-O3.Cl-H
- SMILES N1C(C(C(C1CO)O)O)C1=CNC2C1=NC=NC=2N
-
Chemical Structure
- CAS Registry Number 222631-44-9
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Discontinued (I) | Brazil | IV / unspecified | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Ebola virus infections | - | In volunteers | Discontinued (I) | United Kingdom | IM / Injection | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Ebola virus infections | - | - | Discontinued (Preclinical) | USA | IM / Injection | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Marburg virus disease | - | In volunteers | Discontinued (I) | United Kingdom | IM / Injection | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Marburg virus disease | - | In volunteers | Discontinued (I) | USA | IV / Infusion | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Marburg virus disease | - | - | Discontinued (Preclinical) | USA | IM / Injection | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Middle East respiratory syndrome coronavirus | - | - | Discontinued (Preclinical) | USA | PO / unspecified | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Yellow fever | - | - | Discontinued (II) | USA | IV / Infusion | BioCryst Pharmaceuticals | 28 Feb 2023 |
| Zika virus infection | - | - | Discontinued (Preclinical) | USA | IM / unspecified | BioCryst Pharmaceuticals, Utah State University, National Institute of Allergy and Infectious Diseases | 28 Feb 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| BioCryst Pharmaceuticals | Originator | USA |
| Victoria University of Wellington | Originator | New-Zealand |
| Albert Einstein College of Medicine | Originator | USA |
| BioCryst Pharmaceuticals | Owner | USA |
| Biomedical Advanced Research and Development Authority | Funder | USA |
| National Institute of Allergy and Infectious Diseases | Funder | USA |
| Utah State University | Collaborator | USA |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
Scientific Summary
Pharmacokinetics
Treatment with escalating doses of galidesivir, following administration of single doses (5mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg) by intravenous infusion, showed that drug exposures (Cmax and AUC) at the highest dose were 20 500 ng/mL and 44 600 hr.ng/mL, in a phase I trial, which was similar to or greater than drug exposures needed in non-clinical galidesivir treatment experiments in Marburg virus disease and yellow fever, in healthy volunteers [10] [13] .
Adverse Events
Results from the part I of the phase Ib trial showed that galidesivir was safe and generally well tolerated in COVID-19 patients. No safety signals were identified, and all three dose levels were equally safe. The randomised trial evaluated the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-2019 infections [7] [8]
Pharmacodynamics
Summary
Ebola virus
At day 41, an overall survival rate of 83% was observed following treatment with galidesivir compared with controls (p < 0.001), in a study in rhesus macaques infected with Ebola virus infection. Specifically, survival rate was 66.7% and 100% in the galidesivir 16mg/kg and 25mg/kg groups, respectively, compared with 0% in the control group. Compared with the controls, a 3-log reduction in Ebola virus RNA copies/mL of plasma was observed for the study drug groups [20] .
In a dose ranging trial, galidesivir demonstrated a statistically significant prolongation of survival at the highest dose regimen tested in cynomolgus macaques infected with Ebola virus. However, no animals survived more than 21 days [35] .
In a preclinical study of intramuscular galidesivir in rhesus macaques, treatment with a loading dose of 100 mg/kg bid on Day 2 post Ebola virus inoculation, followed by 25 mg/kg bid for additional nine days, resulted in an overall survival rate of 100% (6/6), versus 0% (0/6) survival rate in the control group (p<0.001). Survival rate of 67% (4/6; p=0.005) was observed for the animal cohort starting treatment on Day 3 using the same loading and maintenance doses, as well as for the cohort treated with 25 mg/kg bid for 14 days starting on Day 2 [19] .
In preclinical 28 day study of IM galidesivir in rhesus macaques models of of ebola virus infection, 100 percent survival was observed in animals receiving 100 mg/kg of galidesivir twice on day 2, followed by 25 mg/kg twice daily for an additional nine days. In contrast, none of the animals of control group survived (p < 0.001). Improved survival (67%, p = 0.005) was observed in animals treated with the same loading, but starting on day 3, and maintenance dose regimen of galidesivir as well as animals treated with 25 mg/kg of galidesivir twice daily for 14 days starting on day 2 (67%, p = 0.005) [17] .
Zika virus
Preclinical studies conducted in rhesus monkeys that were subcutaneously administered with Puerto Rican Zika virus isolate developed high-level viremia by day 2 post-infection in all animals on administration of galidesivir. Monkeys treated with galidesivir 100 mg/kg on day 0 followed by 25 mg/kg for 9 additional days did not develop detectable plasma viremia. Of the monkeys (n=5) that received only galidesivir 100 mg/kg bid on Day zero, detectable plasma Zika virus RNA was found in two animals; however, viremia onset was delayed and magnitude reduced, compared with those in the vehicle cohort (n=5). Animals in groups 1 and 2, achieved sporadically detectable ZIKA virus in CSF, urine and saliva and viral shedding was markedly reduced compared to controls. ZIKA virus infection elicited diminished immune responses in galidesivir-treated monkeys compared with that of the animals treated with controls. Galidesivir administration was well tolerated in the preclinical study [22] [21] .
In a preclinical study of 74 Rhesus macaques infected with a Puerto Rican ZIKV isolate (55 treated with IM galidesivir and 19 with vehicle), high levels of Zika virus in the blood plasma (viremia), and readily detectable ZIKV RNA in cerebrospinal fluid (CSF), saliva and urine post-infection was observed in vehicle-treated control animals. In contrast, galidesivir treated animals did not develop viremia, and were either negative for or had significantly reduced ZIKV RNA in bodily fluids, post first 24 hours SC ZIKV challenge. Partial protection was observed in animals treated with galidesivir later (up to 72 hours post infection), as evident from the delay in onset of viremia and significant reduction in its magnitude compared to controls. Complete protection was observed in animals infected via the IVAG route and were dosed with galidesivir as late as 5 days after infection as evident by no viremia and significant reductions in ZIKV RNA in the CSF compared with controls. Galidesivir was well-tolerated and offered significant protection against ZIKV challenge [17] .
COVID-2019 Infections:
Data from preclinical studies in COVID-19 animal models showed that early administration of galidesivir reduced SARS-CoV-2 viral burden in lung tissue (1.4-1.6 log lower tissue viral burden) and was associated with a significant reduction in damage to lung tissue, compared to vehicle control treated animals.Results suggested that early antiviral treatment of SARS-CoV-2 infection may protect against developing severe COVID-19 lung disease [7]
Therapeutic Trials
Results from the part I of the phase Ib trial showed that a more rapid decline in viral RNA levels in the respiratory tract in an apparent dose-dependent manner was observed in galidesivir treated patients. No clinical efficacy benefit with galidesivir treatment compared to placebo treatment was observed in the trial. The randomised trial evaluated the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-2019 infections [7] [8]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2019 | Trial Update | BioCryst Pharmaceuticals plans a phase I trial for Yellow fever or COVID-2019 (IV) in Brazil (NCT03891420) [37] | 16 Apr 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Feb 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for COVID-2019 infections in Brazil (IV) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Ebola virus infections (In volunteers) in United Kingdom (IM) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Marburg virus disease (In volunteers) in United Kingdom (IM) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Marburg virus disease (In volunteers) in USA (IV) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Yellow fever in USA (IV) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Ebola virus infections in USA (IM) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Marburg virus disease in USA (IM) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Middle East respiratory syndrome coronavirus in USA (PO) [3] Updated 01 Mar 2023 |
| 28 Feb 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Zika virus infection in USA (IM) [3] Updated 01 Mar 2023 |
| 28 Oct 2022 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Ebola-virus-infections in USA (IM, Injection) Updated 28 Oct 2022 |
| 28 Oct 2022 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Marburg virus disease in USA (IM, Injection) Updated 28 Oct 2022 |
| 28 Jan 2022 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Marburg virus disease(In volunteers) in USA (IV, Infusion) Updated 28 Jan 2022 |
| 28 Oct 2021 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Ebola-virus-infections(In volunteers) in United Kingdom (IM, Injection) Updated 28 Oct 2021 |
| 28 Oct 2021 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Marburg virus disease(In volunteers) in United Kingdom (IM, Injection) Updated 28 Oct 2021 |
| 22 Dec 2020 | Scientific Update | Efficacy and adverse events data from phase Ib trials in COVID-2019 infections released by BioCryst [7] Updated 24 Dec 2020 |
| 22 Dec 2020 | Scientific Update | Pharmacodynamics data from preclinical trials in COVID-2019 infections released by BioCryst [7] Updated 24 Dec 2020 |
| 06 Nov 2020 | Trial Update | BioCryst Pharmaceuticals completes enrollments in a Phase-I trial in COVID-2019 infections in Brazil (IV) (NCT03891420) [6] Updated 10 Nov 2020 |
| 04 Nov 2020 | Other | Chemical structure information added Updated 04 Nov 2020 |
| 28 Sep 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Zika-virus-infection in USA (IM) Updated 28 Sep 2020 |
| 09 Apr 2020 | Phase Change - I | Phase-I trials in COVID-2019 infections in Brazil (IV) (NCT03891420) [5] Updated 15 Apr 2020 |
| 09 Apr 2020 | Regulatory Status | Agência Nacional de Vigilância Sanitária and the Brazilian National Ethics Committee approves IND application for galidesivir in COVID-2019 infections [5] Updated 15 Apr 2020 |
| 05 Mar 2020 | Phase Change - II | Phase-II clinical trials in Yellow fever in USA (IV) [9] Updated 11 Mar 2020 |
| 13 May 2019 | Trial Update | BioCryst Pharmaceuticals plans a phase I trial for Yellow fever or COVID-2019 (IV) in Brazil (NCT03891420) [37] Updated 16 Apr 2020 |
| 09 May 2019 | Scientific Update | Pharmacokinetics data from a phase I trial in Marburg virus disease and Yellow fever released by BioCryst Pharmaceuticals [10] Updated 12 Aug 2019 |
| 09 May 2019 | Trial Update | BioCryst Pharmaceuticals completes a phase I trial in Marburg virus disease and Yellow fever (In volunteers) in USA (IV, Infusion) (NCT03800173) Updated 12 Aug 2019 |
| 02 Jan 2019 | Trial Update | BioCryst Pharmaceuticals initiates enrolment in a phase I trial for Marburg virus disease and Yellow fever (In volunteers) in USA [12] Updated 04 Jan 2019 |
| 10 Dec 2018 | Phase Change - I | Phase-I clinical trials in Marburg virus disease (In volunteers) in USA (IV) (NCT03800173) Updated 12 Aug 2019 |
| 10 Dec 2018 | Phase Change - I | Phase-I clinical trials in Yellow fever (In volunteers) in USA (IV) (NCT03800173) Updated 12 Aug 2019 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in phase I clinical trials for Ebola virus infections (In volunteers) in United Kingdom (IM) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in phase I clinical trials for Marburg virus disease (In volunteers) in United Kingdom (IM) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in preclinical trials for Ebola virus infections in USA (IM) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in preclinical trials for Marburg virus disease in USA (IM) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in preclinical trials for Marburg virus disease in USA (IV) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Active Status Review | Galidesivir is still in preclinical trials for Yellow fever in USA (IV) [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Trial Update | BioCryst Pharmaceuticals plans a phase I trial for Yellow fever [30] Updated 20 Sep 2018 |
| 20 Sep 2018 | Trial Update | BioCryst Pharmaceuticals plans trials for Marburg and Ebola infection [30] Updated 20 Sep 2018 |
| 28 Apr 2018 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Ebola-virus-infections in USA (IM, Injection) Updated 28 Apr 2018 |
| 28 Apr 2018 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Middle-East-respiratory-syndrome-coronavirus in USA (PO) Updated 28 Apr 2018 |
| 28 Jan 2018 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Ebola-virus-infections(In volunteers) in United Kingdom (IM, Injection) Updated 28 Jan 2018 |
| 28 Jan 2018 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Marburg virus disease(In volunteers) in United Kingdom (IM, Injection) Updated 28 Jan 2018 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Marburg virus disease in USA (IM, Injection) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Marburg virus disease in USA (IV, Injection) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Yellow-fever in USA (IV) Updated 04 Nov 2017 |
| 04 Oct 2017 | Scientific Update | Pharmacodynamics data from preclinical study in Ebola and Zika virus infections released by BioCryst Pharmaceuticals [17] Updated 06 Oct 2017 |
| 07 Aug 2017 | Trial Update | BioCryst Pharmaceuticals plans a phase I trial for Ebola virus infections [18] Updated 09 Aug 2017 |
| 26 Oct 2016 | Scientific Update | Preclinical data from a in Zika virus infection presented at the IDWeek 2016 (IDW - 2016) [22] Updated 02 Jan 2017 |
| 26 Oct 2016 | Scientific Update | Pharmacodynamics data from a preclinical study in Zika virus infections released by BioCryst Pharmaceuticals [21] Updated 28 Oct 2016 |
| 07 Sep 2016 | Scientific Update | Pharmacodynamics data from a preclinical study in Ebola virus infections released by BioCryst Pharmaceuticals [19] Updated 10 Sep 2016 |
| 05 May 2016 | Phase Change - Preclinical | Preclinical trials in Zika virus infection in USA (IM) before May 2016 [14] Updated 12 May 2016 |
| 05 May 2016 | Trial Update | BioCryst completes a phase I trial in Ebola virus (In volunteers) in United Kingdom [14] Updated 12 May 2016 |
| 31 Mar 2015 | Company Involvement | BioCryst Pharmaceuticals receives grant from US BARDA for galidesivir development as a broad spectrum antiviral drug [2] Updated 16 Jun 2015 |
| 22 Dec 2014 | Scientific Update | Pharmacodynamics data from a proof of concept study in Ebola virus infections released by BioCryst [20] Updated 25 Dec 2014 |
| 15 Dec 2014 | Phase Change - I | Phase-I clinical trials in Ebola virus infections (In volunteers) in United Kingdom (IM) Updated 23 Dec 2014 |
| 15 Dec 2014 | Phase Change - I | Phase-I clinical trials in Marburg virus disease (In volunteers) in United Kingdom (IM) Updated 23 Dec 2014 |
| 07 Nov 2014 | Scientific Update | Pharmacodynamics data from a preclinical trial in Ebola virus infection released by BioCryst Pharmaceuticals [35] Updated 18 Dec 2014 |
| 15 Aug 2014 | Licensing Status | NIAID exercises additional options for galidesivir [31] Updated 18 Dec 2014 |
| 03 Mar 2014 | Phase Change - Preclinical | Preclinical trials in Ebola virus infections in USA (IM) Updated 18 Dec 2014 |
| 03 Mar 2014 | Phase Change - Preclinical | Preclinical trials in Middle East respiratory syndrome coronavirus in USA (PO) Updated 18 Dec 2014 |
| 17 Sep 2013 | Phase Change - Preclinical | Preclinical trials in Marburg virus disease in USA (IM) Updated 18 Dec 2014 |
| 17 Sep 2013 | Phase Change - Preclinical | Preclinical trials in Marburg virus disease in USA (IV) Updated 18 Dec 2014 |
| 07 Dec 2012 | Active Status Review | BioCryst announces the company's strategic restructuring with focus on development of antiviral programmes, including BCX 5191 for HCV and a broad spectrum antiviral galidesivir [24] Updated 18 Dec 2014 |
| 12 Nov 2012 | Scientific Update | Pharmacodynamics data from a preclinical trial in Yellow fever released by BioCryst Pharmaceuticals [23] Updated 18 Dec 2014 |
| 01 Nov 2012 | Phase Change - Preclinical | Preclinical trials in Yellow fever in USA (IV) Updated 18 Dec 2014 |
| 12 Jun 2012 | Licensing Status | BioCryst Pharmaceuticals in-licenses galidesivir from Albert Einstein College of Medicine and Ferrier Research Institute of Victoria University [1] Updated 31 Mar 2021 |
| 02 Apr 2008 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Middle East respiratory syndrome coronavirus in USA (PO) Updated 18 Dec 2014 |
| 03 Jun 2003 | Phase Change - Preclinical | Preclinical trials in Middle East respiratory syndrome coronavirus in USA (PO) Updated 18 Dec 2014 |
References
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BioCryst Provides Update on Galidesivir Program.
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A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19
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BioCryst Reports Fourth Quarter and Full Year 2019 Financial Results and Upcoming Key Milestones .
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BioCryst Completes Phase 1 Clinical Trial of Galidesivir .
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BioCryst Reports Second Quarter 2019 Financial Results .
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BioCryst Initiates Phase 1 Clinical Trial of Galidesivir.
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A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects
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BioCryst Reports First Quarter 2016 Financial Results.
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BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX4430 for the Treatment of Hemorrhagic Fever Viruses.
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A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects
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BioCryst Announces Study Results for BCX4430 in a Non-Human Primate Model of Ebola Virus Infection.
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BioCryst Pharmaceuticals Announces Focused Corporate Strategy and Restructuring.
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BioCryst Awarded Contract by the National Institute of Allergy and Infectious Diseases (NIAID) to Develop BCX4430 for the Treatment of Marburg Virus Disease.
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BioCryst Announces Full Exercise of Underwriters Option to Purchase Additional Shares and Completion of Public Offering of Common Stock.
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NIAID Awards BioCryst New $44 Million Contract to Advance Development of Galidesivir.
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BioCryst Receives Additional $3.5 Million to Fund Clinical Trials of Galidesivir in Yellow Fever.
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BioCryst Receives Additional NIAID Funding to Advance Development of BCX4430 to Treat Hemorrhagic Fever Virus Diseases.
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BioCryst Receives Additional NIAID Funding to Conduct a Non-Human Primate Study of BCX4430 in Ebola Virus Disease.
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BioCryst Reports Second Quarter 2014 Financial Results.
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