SCYNEXIS Oral SCY-078 Achieves Target Exposure With Favorable Safety And Tolerability in Patients with Invasive Candidiasis

SCYNEXIS, Inc.

revealed positive the results of an interim analysis of its second stage study assessing the pharmacokinetics (PK), safety, and tolerability of its novel and structurally distinct glucan synthase inhibitor, SCY-078. The drug candidate is an oral step-down treatment in patients initially treated with intravenous (IV) echinocandin therapy for invasive Candida infections. The company indicated that a once daily oral dose of 750mg of SCY-078 was identified as the dose, which achieved the target exposure with favorable safety and tolerability in patients with invasive candidiasis. The company indicated that the principal trial objective was the identification of the oral dose of SCY-078, which would achieve the target exposure of minimum 80 percent of patients. The company added that the interim population PK model predicted that the dose of 750mg would achieve the target exposure at steady state in more than 80 of the population successfully. SCYNEXIS said that at the end of antifungal therapy, Efficacy, a secondary endpoint in the trial, was also evaluated by determining the global response defined as the resolution of signs and symptoms. The drug developer found that favorable global response rates were similar among all treatment groups. The company stated that of the seven patients randomized to the SCY-078 750mg treatment group, six could achieve a favorable global response representing 86 percent. In comparison, there was five out of seven in the fluconazole group and five out of seven in the SCY-078 500mg group. Both represented a success rate of 71 percent. SCYNEXIS President and CEO, Marco Taglietti, said, "With the project further de-risked, we look forward to initiating subsequent studies of SCY-078, a new class of antifungal, as an IV/oral step-down therapy in patients with refractory invasive fungal infections by the end of 2016 and with invasive candidiasis in the first quarter of 2017." SCYX traded down by $0.07 or 3.47 percent to trade at $1.95 in the pre-market trading.