The FDA has placed a clinical hold on the Scynexis intravenous antifungal clinical trial. But the agency has asked the company to continue with other clinical studies in relation to the antifungal treatment, SCY-078, while reviewing the available pre-clinical and clinical data for the IV trial.
The clinical hold was issued following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the highest doses and concentrations in a Phase I study. Studies evaluating the oral formulation were not affected.
The company said the treatment's potential effects could not be ruled out, even though the study’s rate of thrombotic events was comparable to those reported in other studies using intravenous catheters. Scynexis plans to meet with FDA officials to discuss the data and subsequent studies before July.