Durham’s Chimerix Gets FDA Clearance for Rolling Submission of its Smallpox Treatment
Chimerix is another step closer to getting the final go-ahead for its novel smallpox treatment.
The Durham-based biopharmaceutical company, which develops antiviral medicines for unmet medical needs, this week announced it had received clearance from the FDA for a rolling submission of its New Drug Application for the approval of brincidofovir (BCV) as a medical countermeasure for smallpox.
Chimerix said it intends to begin the rolling NDA submission for BCV in May 2020 with completion targeted for mid-2020.
Brincidofovir, Chimerix’s lead product candidate, is a nucleotide analog that has antiviral activity against all five families of DNA viruses that affect humans, including adenoviruses and variola virus, the virus that causes smallpox.
Brincidofovir has a high barrier to resistance, no bone marrow suppression and a low risk of kidney toxicity, the company has said.
Chimerix has been working with the Biomedical Advanced Research and Development Authority (BARDA) since 2011 to develop brincidofovir, which has demonstrated improved survival rates following confirmed orthopoxvirus infections in multiple animal models.
“The value of being prepared for viral outbreaks has never been clearer. The potential for engineered or naturally occurring resistance to the currently approved therapy has made the development of BCV imperative,” said Mike Sherman, chief executive officer of Chimerix.
“The clearance to begin the rolling submission of the NDA for BCV is an important milestone for both the company and BARDA. Our NDA preparation is already in process and we look forward to working with BARDA on a potential procurement contract in advance of FDA approval.”
Chimerix, founded in 2000, is listed on the NASDAQ Global Market stock exchange.