SCYNEXIS, Inc., a biotechnology company specializing in innovative treatments for drug-resistant infections, has announced the initiation of dosing in its Phase 1 trial for SCY-247. This second-generation triterpenoid antifungal is being developed to combat severe invasive fungal infections, a growing concern due to increasing drug resistance and high mortality rates among vulnerable populations.
Key Highlights:
- Trial Design: The Phase 1 trial is a randomized, double-blind, placebo-controlled study involving approximately 100 healthy subjects. It aims to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of oral SCY-247.
- SCY-247's Potential: SCY-247 has shown promising results in preclinical models against various invasive fungal diseases, including those caused by pathogens listed by the World Health Organization (WHO) as priority. Its development represents a significant step towards addressing the urgent need for new antifungal therapies.
- About SCY-247: As a second-generation antifungal compound from a novel class of glucan synthase inhibitors, SCY-247 offers broad-spectrum activity against multidrug-resistant fungal pathogens. It is the first new class of antifungal compounds approved since 2001, with potential for both oral and intravenous (IV) formulations.
SCYNEXIS anticipates that SCY-247 may receive Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for its IV and oral formulations, highlighting its potential to meet critical unmet needs in the treatment of serious fungal infections.