Scynexis stock slumps as clinical hold continues
- The Food and Drug Administration has asked New Jersey biotech Scynexis for more analysis of preclinical and clinical data on the company's intravenous antifungal SCY-078 before it will lift a current clinical hold.
- As a result, Scynexis now hopes to begin a Phase 2 study in invasive Candida infections in 2018, later than originally planned. Shares in Scynexis plummeted by 36% Tuesday on the news and are now down 87% from a January 2015 peak.
- Development of an oral formulation is still moving forward, according to the company, with enrollment in the Phase 2 FURI study in refractory invasive fungal infections planned for the second quarter of 2017.
In March 2017, the Food and Drug Administration slapped a clinical hold on its intravenous version of SCY-078, stopping the company from starting any new clinical studies for that formulation only.
Positive results from a study testing an oral formulation of the drug had helped to boost Scynexis last October, but it looks like investors now believe the troubles with the FDA over the IV version could read through to the drug's overall development.
"Although Scynexis may continue development of the oral formulation, we believe FDA action around the IV formulation is disruptive to the overall SCY-078 strategy," wrote Needham & Company analyst Alan Carr in a note.
The hold stemmed from three mild-to-moderate thrombotic events in healthy volunteers receiving the highest doses and highest concentrations of intravenous SCY-078 in a Phase 1 study. The company has said this has not had any impact on the oral development track, which is assessing the agent for vulvovaginal candidiasis (VVC or yeast infection).
"Although the recent regulatory action is causing some delay in the development of our intravenous formulation, we are progressing our oral development program as planned while we address the clinical hold on the IV formulation," said Marco Taglietti, CEO of Scynexis, in a prepared statement.
- Scynexis Press release
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