On November 15, Foresee Pharmaceuticals announced that the Phase III clinical trial (The Casppian Study) of its novel formulation drug FP-001 (CAMCEVI) for treating central precocious puberty (CPP) in children has received a second positive recommendation from the Data and Safety Monitoring Board (DSMB). The trial will proceed as planned without adjustments, marking another significant step toward bringing this new treatment to market.

Foresee Pharmaceuticals’ founder and chairman, Ming-Da Jian, stated that this second positive recommendation from the DSMB for the Casppian Phase III clinical trial is a critical milestone in advancing the standard of care for CPP and improving patients’ quality of life. He emphasized that this development brings the company closer to its goal of providing a safe and effective treatment for CPP patients. The primary results of this clinical trial are expected in 2025.

The Casppian Phase III clinical trial is an open-label, multicenter, international study evaluating the efficacy, safety, and pharmacokinetics of leuprolide 42 mg (FP-001 six-month formulation) as a long-acting injectable in pediatric patients with GnRH-dependent central precocious puberty. Foresee’s leuprolide injectable suspension, marketed under the brand name CAMCEVI, is already approved for treating advanced prostate cancer in adult patients. It has demonstrated robust efficacy and safety results, with statistically significant outcomes.

Resource: 逸達兒童藥物臨床 跨步