On Aug. 31, 2020, BioCryst Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID) had awarded BioCryst a new contract totaling $44 million, and has added approximately $3 million to its existing contract, to support the development of galidesivir.

The additional funds under these performance-based contracts support:

• The completion of parts 1 and 2 of an ongoing clinical trial of galidesivir in Brazil
• Conducting a phase 2 clinical trial of galidesivir in non-hospitalized COVID-19 patients at high risk for developing severe disease and complications of COVID-19
• Conducting a clinical pharmacology trial of galidesivir to determine appropriate dosing in patients with renal impairment
• Increasing the supply of galidesivir

Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previous phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

The review of unblinded data from part 1 of an ongoing phase 1 trial (NCT03891420) to assess the safety (primary endpoint), clinical impact and antiviral effects of galidesivir in patients with COVID-19, and a decision to choose a dose and advance into part 2 of the trial, were expected to occur in the fourth quarter of 2020.

Additionally, non-human primate studies and supporting in vitro studies are underway to assess the activity of galidesivir against SARS-CoV-2, the virus that causes COVID-19.