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

Posted on June 30, 2025 by MaryO

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: info@sterotx.com

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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Sterotherapeutics begins Phase II trial for ST-002 targeting Cushing’s Syndrome

Posted on March 2, 2025 by MaryO

US-based clinical-stage company Sterotherapeutics has announced the commencement of a Phase II clinical trial for its drug candidate, ST-002, for treating Cushing’s Syndrome, a rare endocrine disorder.

The trial will assess the drug’s efficacy, tolerability, and safety in individuals with this condition. It is set to be conducted in several European clinical sites.

Sterotherapeutics CEO Manohar Katakam said: “After extensive preparations and based on a large body of scientific data, we are excited to convene this important Investigator Meeting as we progress to the next stage of our clinical development programme.

“This trial represents a significant step forward in our mission to develop transformative therapies for unmet medical needs. Collaboration with our expert investigators is essential to ensuring the highest standards of scientific rigour and patient safety.”

An orphan drug designation was granted by the US Food and Drug Administration (FDA) to the drug underscoring the requirement for new treatments alternatives for this rare condition.

Through this designation, Sterotherapeutics is eligible for various development incentives. These include assistance in the drug development process, certain FDA fee exemptions, post-approval marketing exclusivity of seven years, and tax credits for clinical expenses.

Characterised by longer exposure to high cortisol levels, Cushing’s Syndrome is stated to result in serious health complications like diabetes, osteoporosis, and hypertension.

Sterotherapeutics concentrates on the orphan diseases therapy development. The company stated that its leading programmes, ST-002 for Cushing’s Syndrome and ST-003 for primary sclerosing cholangitis, have shown promise in prior animal and human studies. ST-003 has also been granted an orphan drug designation by the US regulator.

From https://www.clinicaltrialsarena.com/news/sterotherapeutics-trial-st-002/?cf-view&cf-closed

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SteroTherapeutics Receives FDA Orphan-Drug Designation

Posted on April 4, 2018 by MaryO

PHILADELPHIA, April 04, 2018 — SteroTherapeutics, a privately held biopharmaceutical company developing therapies focused on metabolic diseases including non-alcoholic steatohepatitis (NASH), announced today that the U.S. Food and Drug Administration has granted orphan drug designation for ST-002 in the treatment of nonalcoholic fatty liver disease, nonalcoholic steatosis and hyperglycemia in patients with Cushing’s syndrome.

“We are pursuing a drug that has a very real potential to become the optimal agent of choice and a standard of care for these Cushing’s patients,” said Manohar Katakam Ph. D., CEO of SteroTherapeutics. “Our clinical trial will target multiple critical metabolic-related outcomes including the reduction of triglycerides, insulin resistance, weight loss, and the prevention and/or abrogation of hepatic steatosis and fibrosis.”

“The FDA’s orphan-drug designation for Fluasterone highlights the significant unmet and underserved needs for treatment in these individuals,” added Dr. Katakam. “We look forward to realizing the benefits and promise of this potential for Fluasterone in Cushing’s syndrome patients.”

The Orphan Drug Act became law in 1983. Fewer than 5,000 applicants have received this designation, according to the FDA website. Rare conditions are often described as orphan diseases or disorders when there are few or no treatment options. There are approximately 7,000 known orphan diseases.

The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

The designation allows the sponsor of the drug to be eligible for various incentives, including a seven-year period of U.S. marketing exclusivity upon regulatory approval of the drug, as well as tax credits for clinical research costs, annual grant funding, clinical trial design assistance, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

Cushing syndrome occurs when a patient’s body is exposed to high levels of the hormone cortisol over a long period of time (chronic hypercortisolemia) . Cushing syndrome, sometimes called hypercortisolism, affects 15,000 to 20,000 patients in the United States.

Too much cortisol can produce some of the hallmark signs of Cushing syndrome — a fatty hump between a patient’s shoulders, a rounded face, and pink or purple stretch marks on the skin. Cushing syndrome can also result in high blood pressure, bone loss and upper body obesity, increased fat around the neck, and relatively slender arms and legs. Diabetes is frequently a complication found in Cushing’s syndrome patients. These patients also develop nonalcoholic fatty disease and steatosis as a result of the chronic hypercortisolism.

About SteroTherapeutics

SteroTherapeutics, a Philadelphia, PA area based company, is focused on developing novel therapies for significant unmet needs in metabolic disease including liver diseases.

SteroTherapeutics lead products have been proven in previous human studies to possess a strong safety profile and established mechanisms of action. The company’s strategic intent is to focus on understanding disease pathways and how to safely treat and restore an optimal quality of life.  SteroTherapeutics is managed by a veteran team that has significant experience in the pharmaceutical and biotechnology industry. The team has specific experiences in the development, manufacturing and commercialization of small molecule and biologics based products.

INVESTOR RELATIONS CONTACT:
Tony Schor, Investor Awareness, Inc. on behalf of
SteroTherapeutics, LLC
tschor@sterotx.com/ (847) 945-2222 ext. 221

From https://www.econotimes.com/SteroTherapeutics-Receives-FDA-Orphan-Drug-Designation-1236099

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