BioCentury
ARTICLE | Clinical News

BCX5191: IND withdrawn

November 5, 2012 8:00 AM UTC

BioCryst withdrew an IND for BCX5191 after FDA expressed concerns about the HCV candidate's preclinical toxicity profile. According to the company, the agency is concerned that exposure levels of BCX5191 that will be necessary to reduce viral load in humans will be toxic. The company plans to begin additional preclinical studies by year end to determine if low, nontoxic doses of BCX5191 show "meaningful efficacy" in chimpanzees. BioCryst, which said it withdrew the IND within the 30-day waiting period after filing, declined to provide a timeline for completing the studies. ...