Foresee Pharmaceuticals has announced that the independent Data and Safety Monitoring Board (DSMB) has completed its fourth safety review of the Casppian Phase 3 registration study and reported positive findings. Following its evaluation, the DSMB advised that the trial proceed as originally designed, with no changes required.
The Casppian Phase 3 trial is an open-label, multicenter, multinational study designed to assess the efficacy, safety, and pharmacokinetic profile of FP-001, a 42 mg controlled-release formulation of leuprolide, in patients diagnosed with central (gonadotropin-dependent) precocious puberty (CPP).
Foresee’s leuprolide injectable emulsion, 42 mg—commercially available as CAMCEVI—has already received approval for the treatment of advanced prostate cancer in adult patients. In this indication, the product has demonstrated strong efficacy and a favorable safety profile, with statistically significant clinical benefits observed in adult male patients.
“The DSMB’s unanimous confirmation of safety following full enrollment in the Casppian Phase 3 study strongly underscores the promise of our six-month treatment option for children with CPP,” said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development.
“Achieving the study’s primary endpoint marks a critical step forward and signals meaningful progress toward a therapy that could simplify disease management and improve outcomes for young patients.”
Yisheng Lee, M.D., Chief Medical Officer, added, “This recommendation represents more than a procedural achievement—it affirms our dedication to developing alternative treatment options that combine robust effectiveness with good tolerability. It also highlights the potential of long-acting GnRH therapies to significantly enhance the treatment experience for CPP patients. We remain committed to advancing this pivotal study with the highest standards of scientific excellence, patient safety, and ethical responsibility.”
Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer, commented, “With this important validation from the DSMB, we are moving forward with renewed momentum to expand therapeutic options for children living with CPP. As we prepare for the next phase of regulatory engagement, this progress brings us closer to delivering an innovative new treatment. We extend our sincere appreciation to the patients and families participating in the Casppian study—their courage and collaboration are central to this advancement and to our shared goal of improving care.”
The Casppian Phase 3 trial is an open-label, multicenter, multinational study designed to assess the efficacy, safety, and pharmacokinetic profile of FP-001, a 42 mg controlled-release formulation of leuprolide, in patients diagnosed with central (gonadotropin-dependent) precocious puberty (CPP).
Foresee’s leuprolide injectable emulsion, 42 mg—commercially available as CAMCEVI—has already received approval for the treatment of advanced prostate cancer in adult patients. In this indication, the product has demonstrated strong efficacy and a favorable safety profile, with statistically significant clinical benefits observed in adult male patients.
“The DSMB’s unanimous confirmation of safety following full enrollment in the Casppian Phase 3 study strongly underscores the promise of our six-month treatment option for children with CPP,” said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development.
“Achieving the study’s primary endpoint marks a critical step forward and signals meaningful progress toward a therapy that could simplify disease management and improve outcomes for young patients.”
Yisheng Lee, M.D., Chief Medical Officer, added, “This recommendation represents more than a procedural achievement—it affirms our dedication to developing alternative treatment options that combine robust effectiveness with good tolerability. It also highlights the potential of long-acting GnRH therapies to significantly enhance the treatment experience for CPP patients. We remain committed to advancing this pivotal study with the highest standards of scientific excellence, patient safety, and ethical responsibility.”
Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer, commented, “With this important validation from the DSMB, we are moving forward with renewed momentum to expand therapeutic options for children living with CPP. As we prepare for the next phase of regulatory engagement, this progress brings us closer to delivering an innovative new treatment. We extend our sincere appreciation to the patients and families participating in the Casppian study—their courage and collaboration are central to this advancement and to our shared goal of improving care.”