Foresee Pharmaceuticals Receives the Second Positive Recommendation from DSMB to Continue the Casppian Study, a Phase 3 Clinical Trial of Leuprolide (FP-001) Injectable Emulsion for the Treatment of C

• The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned.
• There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients.

TAIPEI, Nov. 15, 2024 /PRNewswire/ — Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) today 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.

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.

“With almost 50% enrollment completed, the second positive DSMB recommendation to continue the Casppian trial without any modification confirms the favorable 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, favorable safety profile in combination with the early indications of efficacy lead us to believe this therapy will become a leading therapy for pediatric 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.  

“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.

“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…