Pharma Focus Asia

Foresee Pharmaceuticals Advances Phase 3 Trial for Leuprolide (Fp-001) in Central Precocious Puberty"

Saturday, October 14, 2023

Foresee Pharmaceuticals (TPEx: 6576) has officially launched the Casppian Phase 3 registration study, marking the administration of the initial patient dose. The Casppian Phase 3 study represents an open-label, multicenter clinical trial designed to assess the effectiveness, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). The study, spanning a duration of 48 weeks, has its primary focus on determining the percentage of patients whose serum LH concentration falls below 4 mIU/mL 30 minutes after a GnRH agonist stimulation test at Week 24. The treatment will be deemed effective for children with CPP if at least 80% of patients exhibit LH suppression below 4 mIU/mL at Week 24. Furthermore, the Casppian study will scrutinize key secondary endpoints, including alterations in bone age, growth rate, and physical indicators of puberty assessed by Tanner stages from the baseline to the study's conclusion at 48 weeks. Notably, these endpoints have received acceptance from the FDA.

Foresee Pharmaceuticals, underscored the significance of GnRH agonists, such as leuprolide, as the established standard of care for CPP patients. Foresee's FP-001, delivered subcutaneously at 42 mg every 6 months, exhibits the potential to be the exclusive ready-to-use leuprolide with a six-month dosing regimen. This development is anticipated to bring considerable benefits to a variety of stakeholders within the CPP community.




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