Sterotherapeutics Announces First Patient Dosed in Phase 2 Clinical Trial Evaluating ST-002 for Cushing's Syndrome

DOYLESTOWN, Pa., June 24, 2025 /PRNewswire/ -- Sterotherapeutics LLC, a clinical-stage biopharmaceutical company focused on rare endocrine diseases, today announced that the first patient has been successfully dosed in its ongoing Phase 2 clinical trial evaluating ST-002 for the treatment of Cushing's Syndrome.

This milestone follows the successful Investigator Meeting held earlier this year in Athens, Greece, marking the official trial activation. The multicenter European study is designed to assess the safety, efficacy, and tolerability of ST-002, a novel therapeutic candidate for patients suffering from Cushing's Syndrome — a rare, debilitating condition caused by chronic exposure to excess cortisol.

"We are pleased to announce the dosing of the first patient in our Phase 2 trial of ST-002," said Dr. Manohar Katakam, Ph.D., Chief Executive Officer of Sterotherapeutics. "This achievement is a testament to the dedication of our clinical teams and the commitment of our investigators. ST-002 has the potential to change the treatment landscape for patients who currently have limited therapeutic options."

Cushing's Syndrome can lead to serious complications including diabetes, cardiovascular disease, osteoporosis and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). With no universally effective treatment available, the initiation of patient dosing marks a critical advancement toward addressing this high unmet medical need.

"Our teams have worked diligently to reach this important moment," added Dr. Constantine Stratakis, MD, PhD, Executive Medical Director of Sterotherapeutics and Professor of Pediatrics, Endocrinology and Genetics. "We remain focused on generating high-quality data that will inform the future development of ST-002 and provide hope for patients living with this challenging disorder and its associated complications, including diabetes and MASLD, the latter being assessed by magnetic resonance imaging and targeted measurements in our clinical study"

The trial is being conducted across multiple sites, with additional sites expected to open in the coming months. ST-002 has previously received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), reinforcing its potential value for patients with rare diseases and enabling regulatory incentives for development.

For more information about the trial or to inquire about participation, please contact: [email protected]

About Sterotherapeutics:

Sterotherapeutics, based in the USA, is a clinical-stage company dedicated to developing novel therapeutics for orphan diseases with significant unmet needs. The company's lead programs, ST-002 for Cushing's Syndrome and ST-003 for primary sclerosing cholangitis, have demonstrated strong preclinical and early clinical results, with favorable safety profiles and well-understood mechanisms of action. Both programs have received Orphan Drug Designation from the U.S. FDA. Learn more at www.sterotx.com

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SOURCE Sterotherapeutics LLC