Dose-optimization data from the Phase 1 study expected Q3 2026 to support Phase 2 proof-of-concept initiation in ADPKD in Q4 2026
JERSEY CITY, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a clinical-stage biotechnology company advancing novel therapies for severe rare diseases, today announced initiation of a Phase 1 study of SCY-770, a first-in-class, potent and direct AMP-activated protein kinase (AMPK) activator. The study will characterize the food-effect and define the pharmacokinetics of two dosing regimens for SCY-770 to support dose selection for the Phase 2 study in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD), on track for Q4 2026.
“Initiating this Phase 1 study of SCY-770 marks an important milestone for SCYNEXIS as we advance a highly differentiated therapy for ADPKD,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “SCY-770 is a potent, orally available direct AMPK activator with compelling preclinical data demonstrating inhibition of cyst cell proliferation and reduction of cyst growth in the kidney, along with a well-characterized safety profile in more than 270 clinical trial participants. With limited disease-modifying options available for patients with ADPKD, we are excited to advance this program and remain on track to initiate our Phase 2 proof-of-concept study later this year, a key value inflection point for the company.”
The Phase 1 study will enroll healthy participants in a sequential design. In the initial cohort, participants will receive a single 500 mg dose of SCY-770 under fed and fasted conditions. Based on these results, subsequent cohorts will evaluate SCY-770 at 750 mg once daily or 500 mg twice daily or placebo, for seven days to inform dose selection for the planned Phase 2 ADPKD study. Topline data are expected in the third quarter of 2026.
SCY-770 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ADPKD.
About SCY-770
SCY-770, a novel and highly selective, direct Adenosine Monophosphate (AMP)-activated protein kinase (AMPK) activator, is being developed as a disease-modifying therapy for ADPKD, a progressive genetic kidney disorder with significant unmet medical need. AMPK activation suppresses the mTOR and cAMP signaling pathways that drive cyst cell proliferation and fluid secretion in ADPKD, providing a mechanistically differentiated approach to slowing disease progression. SCY-770 has been evaluated in several Phase 1 trials and one Phase 2a trial in patients with nonalcoholic fatty liver disease (NAFLD). Compelling preclinical pharmacology data supports its potential utility in ADPKD. The Company aims to develop SCY-770 with the goal of reducing cyst growth and disease progression and improving patient quality of life.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a clinical stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247, currently in clinical stages of development for the treatment and prevention of invasive fungal diseases. 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: The planned Phase 2 study in ADPKD patients expected to begin in Q4, 2026; SCY-770 is a potent and highly selective orally available AMPK activator that can have a profound impact on cell proliferation and cyst growth in the kidney; Results from this study are expected to be available in the third quarter of 2026.. 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, the section titled “Risk Factors” in its most recent Annual Report on Form 10-K filed on March 04, 2026, and in other filings the Company makes with the SEC from time to time. 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
John Fraunces
LifeSci Advisors
Tel: 917-355-2395
jfraunces@lifesciadvisors.com
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