Candidate: Galidesivir (BCX4430)

Category: RNA

Type: Nucleoside RNA polymerase inhibitor designed to disrupt the viral replication process

Status: BioCryst said April 9 it has begun enrolling patients into a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial, which will study 24 hospitalized adults diagnosed with moderate to severe COVID-19, is being funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

On March 5, the company said it was in active dialogue with U.S. public health authorities about whether galidesivir could be useful among potential approaches to treat and prevent COVID-19. Galidesivir has shown broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses and viral disease families that include filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses.

“The virus causing COVID-19 is a coronavirus, but we do not yet know if galidesivir has activity against this specific virus,” BioCryst CEO, President, and Director Jon P. Stonehouse told analysts on the company’s quarterly conference call.

Since 2013, BioCryst has partnered with NIAID and BARDA to develop galidesivir under contracts totaling $82 million: “We have been working with them to figure out how we might help in this global health emergency,” Stonehouse said, adding that talks have focused on testing galidesivir on SARS-CoV-2, learning how to participate in clinical trials, and increasing drug supply.

Galidesivir is also being assessed for yellow fever in a Phase II trial (NCT03891420) under contracts with the National Institute of Allergy and Infectious Diseases (NIAID) and U.S. Department of Health and Human Services (HHS). Last year, galidesivir completed a 32-patient Phase I study in Marburg Virus Disease (NCT03800173).


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA

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