SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)
- No safety concerns or dose limiting toxicities observed
- SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp
- Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247
JERSEY CITY, N.J., Sept. 30, 2025 (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 positive results from a Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation.
"We are pleased by the favorable results from this Phase 1 study demonstrating that orally administered SCY-247 can achieve target exposures for efficacy with favorable tolerability," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "We also observed that orally administered SCY-247 was able to achieve target exposures for invasive fungal disease at doses lower than our first generation fungerp, which may translate to a tolerability advantage. There remains a substantial unmet need for safe and effective, oral and intravenous antifungal agents to treat invasive fungal infections, particularly those caused by resistant fungi. The clinical data from our Phase 1 study, along with pre-clinical efficacy data generated to date, favorably position SCY-247 as a strong product candidate to meet these significant needs. We are looking forward to continuing the development of our second generation fungerp."
Phase 1 Study Description:
The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in 8 participants, with 6 participants receiving SCY-247 and 2 receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts.
Phase 1 Study Results:
SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. The most common adverse events were mild to moderate headache reported in 16.7% of participants receiving SCY-247 and 4.5% of participants receiving placebo, and diarrhea reported in 9% and 9% of participants receiving SCY-247 and placebo respectively.
SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed (Tmax ranging from 3 to 7 hours), and systemic exposure (Cmax and AUC) increased with dose. The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on pre-clinical models of invasive candidiasis available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ:SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company's proprietary antifungal platform "fungerps." Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: any advantages of SCY-247 over existing antifungals and continued development of SCY-247. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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