Foresee Pharmaceuticals' Camcevi Shows Promise in Rare Pediatric Condition

Foresee Pharmaceuticals has announced positive results from a phase 3 study of its prostate cancer medication Camcevi in children with central precocious puberty (CPP), potentially expanding the drug's therapeutic applications.

Successful Phase 3 Results for CPP Treatment

The Taiwan-based company's phase 3 Casppian study evaluated a 42 mg dose of leuprolide mesylate (FP-001), administered every six months. The primary endpoint focused on serum luteinizing hormone (LH) suppression, with 94% of patients achieving LH levels below 4 mIU/mL at 60 minutes after GnRHa stimulation at week 24. This statistically significant result exceeded the pre-specified criteria for success.

Dr. Bassem Elmankabadi, SVP of clinical development at Foresee, emphasized the significance of meeting the primary endpoint, stating, "It underscores the potential of FP-001 to offer a meaningful new treatment option, potentially improving convenience and adherence of children with CPP."

Expanding Camcevi's Therapeutic Reach

Camcevi, initially approved in 2021 for advanced prostate cancer treatment, utilizes Foresee's stabilized injectable formulation (SIF) technology. This allows for ready-to-use injectables with customizable therapeutic durations. The drug's potential in CPP treatment represents a significant expansion of its applications.

CEO and founder Ben Chien, Ph.D., expressed confidence in the long-acting formulation as a "potential best-in-class therapy" based on the "robust efficacy data" from the Casppian study. The company plans to present full study results at an upcoming scientific conference and engage with global regulatory authorities to discuss submitting a new drug application by mid-year.

Safety Profile and Future Prospects

The safety profile of FP-001 in the Casppian study was reported to be consistent with the established class profile of GnRH agonists. Dr. Yisheng Lee, chief medical officer, noted that the most common adverse events were typically mild to moderate in severity.

Foresee Pharmaceuticals is also exploring Camcevi's potential in other indications, including a phase 3 trial for premenopausal breast cancer patients in China. Additionally, the company is developing two oral MMP-12 inhibitors for immune-fibrotic diseases, further diversifying its pipeline.