Federal health authorities said Tuesday that they have committed up to $35 million to a Durham drug developer for the continued development of a drug to treat Ebola and related viral infections.
The award from the U.S. Department of Health and Human Services is the second major injection of funding for the antiviral being developed by BioCryst Pharmaceuticals.
BioCryst will receive $12.1 million in the base contract, with a potential $22.9 million in additional research spending from the Biomedical Advanced Research and Development Authority. BARDA is the unit of the U.S. Department of Health and Human Services that develops treatments against potential bioterror agents and epidemic threats to national security.
The latest round of federal research funding will pay for large-scale manufacturing of BioCryst’s drug, BCX4430, for application in clinical studies and other tests to be conducted in advance of BioCryst filing an application for the drug’s approval.
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In its announcement, DHHS called BCX4430 a “promising experimental drug for Ebola.”
The 50-employee company has been developing BCX4430 against the Marburg virus, which is similar to Ebola, and the drug has already shown effectiveness in primate studies. Virologists consider BCX4430 a “broad spectrum antiviral” that could fight off a wide range of dangerous and deadly viruses for which there are limited or no treatments.
“Under product development funding from the National Institutes of Health, BioCryst currently is conducting Phase 1 safety studies of BCX4430 for safety in healthy volunteers,” the federal agency said in a statement. “If these studies show that the drug is safe, BCX4430 could become one of the possible treatments tested for efficacy in clinical studies.”
The human study, which will test the safety of BCX4430 on up to 88 subjects who are not infected, is funded by the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health. The primate study was conducted by the U.S. Army Medical Research Institute of Infectious Diseases. The studies are part of a $29.2 million federal grant awarded in 2013, of which BioCryst has used $25 million to date.
BCX4430 prevents Ebola from reproducing in the body and is the first small molecule drug to treat Ebola that BARDA has supported. BARDA is also paying for the development of the experimental drug cocktail ZMapp by Mapp Biopharmaceuticals as well as experimental vaccines being developed by a pharmaceutical consortium of GlaxoSmithKline, BioProtection Services/NewLink Genetics and Profectus BioSciences.
If any of these drugs or vaccines proves to be safe and effective, they would be acquisition candidates for the U.S. Strategic National Stockpile, through the BARDA’s Project BioShield.
In December, the 29-year-old company received federal approval for permamivir, its first commercial drug in this country. The intravenous flu medication goes by the commercial name Rapivab.
BioCryst employs more than half is workforce at its Durham headquarters, and about 20 people at its lab facility in Birmingham, Ala.
The company’s shares closed Tuesday at $9.03, up 46 cents. The stock is down 26 percent this year.