Phase II- Repurposing CRH antagonists for the treatment of endometriosis

PROJECT SUMMARY The main goal of this Phase II SBIR project is to de-risk and advance the development of an oral therapeutic that is intended to medically manage both the progression of endometriosis and the pain associated with it. This could result in a reduction or elimination of the need for repeated surgical interventions. Endometriosis affects approximately 10% of women globally and is a significant cause of infertility and chronic debilitating pain in women and teenagers. Unfortunately, there is no cure for this widespread condition, which often takes 6 to 10 years to diagnose. Currently, available treatments, such as hormone therapy, pain management, or surgery, do not adequately address disease progression. They often come with undesirable side effects or fail to provide lasting relief. Surgeries may not prevent the recurrence of the disease, leading women to undergo multiple surgical procedures during their reproductive years. All current hormonal medications to treat endometriosis negatively affect fertility. Our STTR Phase I results indicated that Sur180 Therapeutics' drug candidate significantly reduced pain and markers of proliferation. It also provided lasting protection after treatment had stopped in a well-validated rat model of endometriosis without disrupting the estrous cycle. Sur180 Therapeutics plans to reposition its drug candidate, protected by a new method-of-use patent recognizing its paracrine role in the reproductive system. In Phase II, our team will further assess the drug's impact on reproductive health and identify the lowest effective dose and dosing schedule to directly inform future clinical trials. The team will initiate a dialogue with the FDA and prepare for a pre-Investigational New Drug (IND) discussion. Key milestones include validating that the drug preserves fertility, demonstrating effective pain management with low doses, and obtaining FDA guidance. Success in these areas will enable Sur180 Therapeutics to efficiently prepare for a future market entry, capitalizing on previously approved safe drugs and securing market exclusivity. This will ultimately improve patients' quality of life and reduce healthcare costs. The successful outcomes of this project represent a significant advancement in providing a long-lasting, disease-modifying solution for millions of women worldwide.