SCYNEXIS Announces Encouraging Phase 1 Findings for Antifungal Candidate SCY-247
Positive Phase 1 Results: SCYNEXIS reported favorable Phase 1 results for its antifungal drug SCY-247, which showed good tolerability with only mild to moderate adverse events in a study of 88 healthy participants.
Improved Tolerability and Efficacy: SCY-247 demonstrated better tolerability and effective exposures against resistant Candida strains compared to the first-generation medication, supporting its further development.
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SCYNEXIS Secures FDA QIDP Designation for SCY-247, Ensuring 10 Years of Market Exclusivity
- FDA Designation: SCYNEXIS's SCY-247 has received QIDP and Fast Track designations from the FDA, ensuring at least 10 years of market exclusivity post-approval, thereby enhancing the company's competitive edge in the antifungal market.
- Clinical Trial Plans: The company expects to initiate a Phase 1 study of SCY-247 with the IV formulation and a Phase 2 study with the oral formulation in 2026, aiming to address the treatment needs for invasive candidiasis and further advance product development.
- Antifungal Activity: SCY-247 has demonstrated potent activity against various difficult-to-treat fungal pathogens, including multi-drug-resistant Candida auris, in multiple preclinical studies, indicating its potential to combat public health threats.
- Market Demand: As the threat of multi-drug resistant fungal infections escalates, the development of SCY-247 not only meets the urgent market need for novel antifungal agents but also holds the potential for significant economic returns for the company.
Scynexis Reveals Federal Support for Partnership Between Hackensack Meridian CDI and Johns Hopkins Researchers to Create Innovative Therapies, Including New Fungerps, for Resistant Fungal Infections
Federal Grant Announcement: SCYNEXIS, Inc. has received a five-year federal grant of $7 million annually to support the development of new antifungal therapeutics, particularly next-generation triterpenoid antifungals (fungerps), aimed at combating resistant fungal infections.
Research Collaboration: The grant will establish a Center of Excellence in Translational Research (CETR) in collaboration with Hackensack Meridian Center for Discovery and Innovation and Johns Hopkins Bloomberg School of Public Health, focusing on advancing fungerp candidates from preclinical stages to IND-ready status.
Fungal Infection Statistics: Approximately four million deaths annually are attributed to fungal infections globally, highlighting the urgent need for new therapeutics to address the growing threat of resistant fungal pathogens.
Triterpenoid Antifungals Overview: Triterpenoid antifungals represent a novel class of glucan synthase inhibitors, with the first compound, Ibrexafungerp, already approved for treating vulvovaginal candidiasis, while additional candidates are in various stages of development to tackle multidrug-resistant fungal infections.
