FDA asks Scynexis to hold initiation of new clinical studies using IV formulation of SCY-078
Scynexis has been asked by the US Food and Drug Administration (FDA) to put a hold on the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until it finishes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078.
Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree on subsequent clinical studies with the IV formulation of SCY-078 is scheduled for the second quarter of 2017.
The clinical hold decision was issued by the FDA following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study.
The potential contribution of the IV formulation of SCY-078 to these events cannot be ruled out even though rates of thrombotic events due to intravenous catheters reported in the literature are comparable to those observed in the Phase 1 study.
Scynexis is working closely with the FDA to review the data supporting the use of the IV formulation and dose regimen of SCY-078 selected by the Company for its upcoming clinical trials.
Source: Company Press Release