First Participants Dosed in Phase Trial of SCY-247, Building on Oral Formulation Success

SCYNEXIS has announced that the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial evaluating the intravenous (IV) formulation of SCY-247, the company's second-generation triterpenoid antifungal therapy being developed for the treatment of invasive candidiasis (IC) and prophylaxis of invasive fungal disease, with results expected before the end of 2026.¹

The milestone marks the latest step in a rapidly advancing development program for SCY-247, which in January 2026 received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA—regulatory recognitions that reflect the therapy's potential to address the serious and growing unmet need posed by drug-resistant fungal infections.^1,2 The QIDP designation, which applies to antibacterial and antifungal drugs intended to treat serious or life-threatening infections, will afford SCY-247 at least a 5-year exclusivity extension upon approval. The Fast Track designation enables more frequent FDA interactions, potential eligibility for accelerated approval and priority review, and the option for rolling review of application sections.²

"Following the FDA's recent decision to grant SCY-247 both Qualified Infectious Disease Product and Fast Track designations, we are pleased to announce the dosing of the first cohort of participants in our phase 1 SAD/MAD trial of IV SCY-247," said David Angulo, MD, president and chief executive officer of SCYNEXIS. "An IV formulation of SCY-247 would provide additional flexibility for the optimal management of patients with invasive candidiasis, and we are excited by the achievement of this important development milestone, which moves this innovative antifungal closer towards meeting the needs of patients suffering from difficult-to-treat severe fungal diseases."¹

The IV trial builds directly on the positive Phase 1 SAD/MAD data announced in September 2025 for the oral formulation of SCY-247, which demonstrated favorable pharmacokinetic and pharmacodynamic properties and—notably—achieved target exposures for invasive fungal disease at doses lower than those required by first-generation fungerps.¹ That tolerability advantage has been a key talking point in SCYNEXIS's positioning of SCY-247 as a differentiated successor within its proprietary fungerp platform. The first approved fungerp, ibrexafungerp (Brexafemme; GSK), is FDA-approved for the treatment of vulvovaginal candidiasis and for the reduction of recurrent vulvovaginal candidiasis, and has since been licensed to GSK.¹

SCY-247's preclinical profile has demonstrated broad-spectrum antifungal activity against some of the most difficult-to-treat resistant pathogens in the current landscape, including multi-drug-resistant Candida auris and echinocandin-resistant C. glabrata, as well as azole-resistant Aspergillus species.² The breadth of that activity is particularly consequential given the accelerating pace of antifungal resistance globally. A collaborative, multi-institution scientific publication in December 2025 reported that C. auris is spreading across the globe and gaining in virulence—a finding that has amplified calls for novel antifungal agents capable of addressing pathogens that do not respond to currently approved therapies.²

As Angulo told Contagion in a prior interview discussing SCY-247's potential, the dual threats of rising antifungal resistance and the limited pipeline of novel antifungal mechanisms underscore why development programs like SCY-247 carry outsized importance for the infectious disease community.

With the IV phase 1 trial now enrolling, SCYNEXIS has a busy 2026 pipeline ahead. In addition to the IV SAD/MAD study, the company expects to initiate a phase 2 study of the oral formulation in invasive candidiasis and aims to release proof-of-concept data from that program before year's end.² SCYNEXIS has also noted that it continues to explore non-dilutive funding opportunities to further support the SCY-247 program, reflecting the health security dimensions of addressing antifungal resistance at scale.

References

1. SCYNEXIS announces first participants dosed in a Phase 1 single ascending dose and multiple ascending dose trial of intravenous SCY-247. News release. SCYNEXIS, Inc. February 26, 2026. Accessed March 25, 2026. https://www.globenewswire.com/news-release/2026/02/26/3245564/0/en/SCYNEXIS-Announces-First-Participants-Dosed-in-a-Phase-1-Single-Ascending-Dose-and-Multiple-Ascending-Dose-Trial-of-Intravenous-SCY-247.html
2. SCYNEXIS receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for SCY-247. News release. SCYNEXIS, Inc. January 21, 2026. Accessed March 25, 2026. https://www.globenewswire.com/news-release/2026/01/21/3222722/0/en/SCYNEXIS-Receives-FDA-Qualified-Infectious-Disease-Product-QIDP-and-Fast-Track-Designations-for-SCY-247.html