Foresee Pharmaceuticals has announced a second positive safety review from the independent Data and Safety Monitoring Board (DSMB) for its Casppian Phase 3 registration study of leuprolide (FP-001) injectable emulsion for the treatment of central precocious puberty (CPP). The DSMB recommended that Foresee continue the trial without any modifications, reinforcing the favorable safety profile observed to date.
The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled release in patients with CPP. Foresee's leuprolide injectable emulsion, 42 mg (marketed as CAMCEVI® for advanced prostate cancer), utilizes Foresee's Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology.
Safety and Efficacy
The positive DSMB recommendation is based on a review of safety data from the ongoing trial, which has nearly 50% enrollment completed. According to Foresee, no safety concerns have been identified with the use of Leuprolide (FP-001) in pediatric CPP patients. Early indications of efficacy, combined with the favorable safety profile, suggest that this therapy could become a leading treatment option for pediatric patients with CPP.
CPP and Current Treatment Landscape
CPP is a condition characterized by the early activation of the hypothalamic-pituitary-gonadal axis, leading to premature sexual development in children between 2 and 9 years of age. CPP can result in significantly short stature as adults, as well as social, psychological, and emotional challenges, including lower self-esteem, stress, anxiety, and depression. According to the National Organization for Rare Disorders (NORD), CPP affects approximately 1 in 5,000 to 10,000 children. Gonadotropin-releasing hormone (GnRH) agonists, such as leuprolide, are the most commonly used treatments for CPP.
Foresee's Pipeline and Future Plans
Foresee anticipates topline results from the Casppian Phase 3 trial in 2025. The company is also developing other therapies using its SIF technology, including a 3-month version of CAMCEVI for advanced prostate cancer. Additionally, Foresee is advancing preclinical and clinical programs targeting rare and severe diseases with high unmet needs.
"This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children with CPP," said Dr. Ben Chien, CEO and Chairman of Foresee.
