NIAID Awards BioCryst $44M for COVID-19 Treatment Work

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Durham’s BioCryst Pharmaceuticals has landed a new federal contract totaling $44 million and added some $3 million to an existing contract to support the development of galidesivir as a possible COVID-19 treatment.

The funding is from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Galidesivir is an investigational broad-spectrum antiviral drug that BioCryst is developing not only for possible treatment of COVID-19, but also targeting other life-threatening diseases.

The new NIAID funds will 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.

Next steps in development

In earlier Phase 1 clinical trials, galidesivir was found to be safe and well tolerated in healthy subjects. In a current Phase 1 clinical trial, galidesivir is being tested for its safety, clinical impact and antiviral effects in patients with COVID-19. Outcomes of the study and a decision about proceeding with the second part of the trial are expected to occur in the fourth quarter of 2020.

Galidesivir has demonstrated broad-spectrum activity in test tubes against more than 20 RNA viruses in nine different families, including the coronaviruses that cause Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). It is also a potential treatment for the highly contagious diseases Marburg virus disease and Yellow Fever.

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.

BioCryst moved its headquarters to Durham from Birmingham, Alabama in 2010. It discovers small-molecule medicines that treat rare diseases for which there is a significant unmet need. The company focuses on illnesses in which enzymes play a key role in the biological pathway.

Since September 2013, NIAID has supported BioCryst in developing galidesivir as 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.

Kelly Duffort, NCBiotech Writer
Mon, 08/31/2020 - 15:29