Foresee Pharmaceuticals announced on the 17th that its Phase III Casppian clinical trial has received a third consecutive positive recommendation from the Data and Safety Monitoring Board (DSMB), allowing the study to proceed without modifications according to the current clinical plan.
The Casppian Phase III clinical trial is an open-label, multinational, multi-center study designed to evaluate the efficacy, safety, and pharmacokinetics of leuprolide acetate 42 mg (FP-001 six-month formulation) long-acting injection in pediatric patients with GnRH-dependent central precocious puberty (CPP). Foresee’s leuprolide acetate injectable suspension, commercially available under the CAMCEVI® brand, has already been approved for the treatment of advanced prostate cancer in adult patients, demonstrating strong efficacy, a favorable safety profile, and statistically significant results.
Dr. Bassem Elmankabadi, Foresee’s Senior Vice President of Clinical Development, stated that with nearly 75% of patient recruitment completed, the third positive DSMB feedback further reinforces the safety of FP-001 (42 mg six-month long-acting injection) for patients. He added that preliminary efficacy signals support their confidence in this treatment, which has the potential to be a breakthrough for pediatric CPP therapy. The company remains committed to the highest safety and ethical standards and aims to complete patient recruitment for this pivotal study as quickly as possible.
Dr. Yuhua Li, Chief Technology Officer at Foresee, emphasized that the DSMB’s continued positive recommendations validate Foresee’s innovative, stable long-acting injection technology across multiple indications, including its application in pediatric CPP patients.
Dr. Ben Chien, Founder and Chairman of Foresee, noted that the third DSMB positive recommendation for the Casppian Phase III trial marks a significant step toward improving the standard of care for CPP and enhancing patients’ quality of life. He added that the company is one step closer to delivering a safe and effective treatment for pediatric CPP patients and expects to obtain primary results from the trial in 2025.
Understanding Central Precocious Puberty (CPP)
GnRH-dependent central precocious puberty (CPP) is a condition in which the hypothalamic-pituitary-gonadal (HPG) axis is prematurely activated, leading to early sexual development in children aged 2 to 9. Beyond the physical changes, CPP can cause social, psychological, and emotional challenges, including low self-esteem, stress, anxiety, and depression. If left untreated, children with CPP may experience compromised adult height, negatively impacting their overall quality of life.
According to the National Organization for Rare Disorders (NORD), CPP affects approximately 1 in 5,000 to 10,000 children, with 80–90% of cases classified as idiopathic. The condition is far more common in girls, occurring at a 20-fold higher rate than in boys. Gonadotropin-releasing hormone (GnRH) agonists, such as leuprolide acetate, are the most widely used standard therapy for treating pediatric CPP.
Resource: 逸達兒童藥物臨床 三度獲DSMB正面回饋持續進行
