DOYLESTOWN, PA — Sterotherapeutics has initiated a Phase 2 clinical trial for ST-002, an innovative drug candidate aimed at treating Cushing’s Syndrome, a rare and severe endocrine disorder. The launch represents a crucial step toward addressing the unmet needs of patients who have limited therapeutic options.
An Investigator Meeting to support the trial’s launch is scheduled for February 24, 2025, in Athens, Greece. During this event, clinical investigators, research coordinators, and stakeholders will collaborate to align on trial objectives, discuss protocols, and ensure best practices for the study’s execution.
“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 trial will evaluate the safety, tolerability, and efficacy of ST-002 in patients with Cushing’s Syndrome. This condition is caused by prolonged exposure to excessive cortisol, potentially leading to diabetes, hypertension, osteoporosis, and life-threatening complications if untreated. Despite its severe effects, treatment options remain limited, creating a high demand for new and effective solutions.
“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,” said Dr. Constantine Stratakis, Executive Medical Director of Sterotherapeutics. “We look forward to engaging with our investigators to advance this promising therapy.”
The trial will take place at multiple clinical sites across Europe. Reflecting its potential significance, ST-002 has received an orphan drug designation from the U.S. Food and Drug Administration. This designation recognizes the need for advancements in rare disease treatment and offers Sterotherapeutics development incentives, including regulatory advantages and seven years of market exclusivity after FDA approval.
By taking this critical step, Sterotherapeutics is advancing its mission of developing groundbreaking treatments. If successful, the Phase 2 trial could pave the way for effective and accessible relief for patients challenged by a rare and debilitating condition.
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