SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247, a Second-Generation Fungerp Candidate for Invasive Fungal Infections
JERSEY CITY, N.J., Dec. 18, 2024 (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 that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections.
“We are pleased to advance our potent, second-generation fungerp candidate SCY-247 into the clinic in a Phase 1 study,” said David Angulo, M.D., President and Chief Executive Officer. “SCY-247 has consistently shown promising results in preclinical models of several invasive fungal diseases and has activity against many of the fungi on the World Health Organization (WHO) fungal priority pathogen list. With the vulnerable population at risk of invasive fungal diseases increasing, their high mortality rates, and the growing concern for drug resistance, there is an urgent need for new therapies. We believe SCY-247 has the potential to address critical unmet needs in this space, and progressing this novel antifungal represents a very significant milestone toward our goal of delivering a new weapon to fight serious fungal infections.”
The Phase 1 trial is a randomized, double-blind, placebo-controlled study of single and multiple ascending doses of oral SCY-247 in approximately 100 healthy subjects. The primary endpoint is safety and tolerability, and the secondary endpoint is pharmacokinetics.
About SCY-247
SCY-247 is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), being developed to address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. The triterpenoid class of antifungals represents the first new class of antifungal compounds approved since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in Phase 1 of development and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including against multidrug resistant fungal pathogens. SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247.
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 pre-clinical and discovery phase, 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: SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations 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 28, 2024, and form 10-Q for the quarter ending September 30, 2024, 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.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Released December 18, 2024