NIAID Awards BioCryst New $44 Million Contract to Advance Development of Galidesivir

RESEARCH TRIANGLE PARK, N.C., Aug. 31, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded BioCryst a new contract (75N93020C00055) totaling $44 million, and has added approximately $3 million to its existing contract (HHSN272201300017C), 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

“With this additional investment in galidesivir by NIAID, we are now positioned to further evaluate and advance galidesivir through additional clinical trials in different settings beyond hospitalized patients, and to accelerate our manufacturing activities to increase drug supply,” said Jon Stonehouse, chief executive officer of BioCryst.

“We appreciate the financial investment the government continues to make in the galidesivir program. We believe broad-spectrum antivirals, like galidesivir, are critical to combat both the current COVID-19 pandemic and threats from future viruses,” Stonehouse added.

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, are 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.

The galidesivir development program is substantially funded with federal funds from NIAID and by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Since September 2013, NIAID has supported BioCryst in developing galidesivir as broad-spectrum antiviral therapeutic under contract HHSN272201300017C. Since March 2015, BARDA has supported the galidesivir development program under contract HHSO100201500007C for the continued development of galidesivir as a potential broad- spectrum antiviral treatment for filoviruses. In addition to the new contract award from NIAID, there is currently approximately $27 million remaining on the existing BARDA contract.