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SCYNEXIS Announces Successful Completion of Phase 1 Trial Evaluating Intravenous (IV) Formulation of Ibrexafungerp
Safety and tolerability of new liposomal IV formulation confirmed to reach target exposure in single ascending dose (SAD) and multiple ascending dose (MAD)
About this update from Scynexis, Inc.
[{"type":"text","content":"Safety and tolerability of new liposomal IV formulation confirmed to reach target exposure in single ascending dose (SAD) and multiple ascending dose (MAD) study\nJERSEY CITY, N.J., Nov. 09, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the successful completion of a Phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of a liposomal intravenous (IV) formulation of ibrexafungerp in healthy subjects. “The data from this study support the safety of the liposomal IV formulation of ibrexafungerp, allowing us to progress its development,” said David Angulo, M.D., Chief Medical Officer, SCYNEXIS. “Having the flexibility to easily switch between IV and oral formulations, when needed, will enable physicians to maximize the potential benefits from this innovative antifungal in a broad range of clinical settings often involved in the management of invasive fungal diseases, including intensive care units, hospital wards and outpatient services.” The randomized double-blind, placebo-controlled trial, designed as a single ascending dose (SAD) and multiple ascending dose (MAD) study, was conducted in 64 healthy volunteers with treatment durations of up to seven days. The liposomal IV formulation of ibrexafungerp was generally well tolerated with no serious adverse events reported. The most common adverse events were mostly mild (few moderate) reactions at the infusion site. The dosing was successfully progressed until the target exposure was achieved (i.e., exposure associated with efficacy from animal models). “The breakthrough achievement of this milestone moves SCYNEXIS closer to our vision of providing potentially life-saving antifungal treatments for use in multiple heath care settings,” said Marco Taglietti, M.D., President and Chief Executive Officer, SCYNEXIS. “Severe fungal infections can be extremely dangerous, especially for patients with compromised immune systems. This IV formulation could complement our late-stage oral ibrexafungerp clinical development programs and provide an important treatment option with a broad-spectrum antifungal activity for patients battling these serious infections.” SCYNEXIS is currently evaluating strategic options to be...