BioCryst Pharmaceuticals has landed a new contract, totaling $44m, from the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of galidesivir. The institute also has added approximately $3m to its existing contract with the company.
The efforts the funding will help support reportedly includes:
- Completion of parts 1 and 2 of an ongoing clinical trial of galidesivir in Brazil
- Conducting a Phase II 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
Jon Stonehouse, BioCryst CEO, said the funding will enable the company to expand its research into the COVID-19 treatment.
“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,” he said, “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 reportedly determined to be safe and well tolerated in earlier Phase I 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 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.
Money for the galidesivir development program comes in large part from federal funds from NIAID and by Biomedical Advanced Research and Development Authority (BARDA). Since September 2013, NIAID has supported BioCryst in developing galidesivir as a broad-spectrum antiviral therapeutic.
Since March 2015, BARDA has supported the galidesivir development program 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.