Foresee Pharma gets positive recommendation from DSMB to continue Casppian phase 3 study of leuprolide injectable emulsion to treat central precocious puberty
Overview
Foresee Pharmaceuticals, a Taiwan and US-based biopharmaceutical company, announces the second positive safety review by the independent Data and Safety Monitoring Board for its Casppian phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial without any modification.
Casppian Phase 3 Study
- The Casppian phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP).
- Foresee’s leuprolide injectable emulsion, 42 mg (marketed under the brand name Camcevi), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer.
From the EVP: Foresee
- With almost 50% enrollment completed, the second positive DSMB recommendation to continue the Casppian trial without any modification confirms the favourable safety profile of FP-001, 42 mg 6 month long-acting, ready-to-use, subcutaneous injectable treatment in patients with CPP. The differentiated product profile, favourable safety profile in combination with the early indications of efficacy lead us to believe this therapy will become a leading therapy for paediatric patients with CPP.
- We look forward to continuing to enroll patients and are dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial,” said Bassem Elmankabadi, M.D., senior vice president of clinical development of Foresee.
Words from the CTO: Foresee
“This DSMB recommendation again demonstrates the success of Foresee's pioneering Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology in several disease indications, including children with CPP,” said Dr. Yuhua Li, chief technology officer of Foresee.
From the CEO: Foresee
- The outcome of the second DSMB for the Casppian study is a significant step toward our mission of improving the standard of care and the quality of life of children with CPP,” said Dr. Ben Chien, CEO and chairman of Foresee.
- This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children with CPP. Topline results from this trial as anticipated in 2025.
The CPP
- GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their “hypothalamus - pituitary gland - gonadal axis” is activated too early, causing children to enter puberty prematurely, between 2 years and 9 years of age.
- CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life.
- Acording to the NORD (National Organization for Rare Disorders) website, CPP occurs in 1 out of 5,000 to 10,000 children.
- It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female-to-male ratio of around 20.
- Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP.
About the Company: Foresee
- Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange.
- Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programmes targeting rare and severe disease areas with high unmet needs.
