Sterotherapeutics, Announces Initiation of a Phase 2 Clinical Trial for Patients with Cushing's Syndrome

DOYLESTOWN, Pa., Feb. 24, 2025 /PRNewswire/ -- Sterotherapeutics, a leading biopharmaceutical company dedicated to advancing innovative therapies, is announcing the launch of a Phase 2 clinical trial for ST-002, a novel drug candidate for patients with Cushing's Syndrome, a rare endocrine disorder with very limited available therapeutic options. An Investigators Meeting to start this study is scheduled for Monday, 24 February 2025, in Athens, Greece, when clinical investigators, research coordinators, and stakeholders will discuss trial objectives, protocol details, and best practices for successful execution of this highly anticipated clinical trial.

"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 program," said Manohar Katakam, Ph.D., Chief Executive Officer of Sterotherapeutics. "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 rigor and patient safety."

The Phase 2 clinical trial aims to evaluate the safety, efficacy, and tolerability of ST-002 in patients with Cushing's syndrome. Cushing's syndrome is a rare and serious endocrine disorder caused by prolonged exposure to excessive cortisol levels. It can lead to severe complications such as diabetes, hypertension, osteoporosis, and increased mortality if left untreated. Despite its devastating impact, treatment options remain limited, and there is a high unmet medical need for novel, effective therapies.

"This Investigator Meeting will play a crucial role in optimizing the trial process and ensuring that our research is conducted with the utmost precision and integrity," added Dr. Constantine Stratakis, Executive Medical Director of Sterotherapeutics. "We look forward to engaging with our investigators to advance this promising therapy." The study will be conducted at multiple clinical sites in Europe.

Sterotherapeutics has received an orphan drug designation for ST-002 from the U.S. Food and Drug Administration (FDA), recognizing the need for new treatment options for this rare condition and providing regulatory incentives to support the development of this promising therapy. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. 

For more information about the Investigator Meeting or to inquire about participation in the Phase 2 trial, please contact [email protected].

About Sterotherapeutics:

Sterotherapeutics based in USA, is a clinical stage company focused on developing novel therapeutics for orphan disease with significant unmet needs. Sterotherapeutics' lead programs, ST-002 to treat Cushing's syndrome and ST-003 to treat primary sclerosing cholangitis, have been demonstrated to be effective in previous animal and human studies and have a favorable safety profile and established mechanisms of action. Both ST-002 and ST-003 have received Orphan Drug Designation from the U.S. FDA. Learn more at www.sterotx.com

Contact: [email protected]
www.sterotx.com
1-267-300-0010

SOURCE Sterotherapeutics LLC