Foresee Pharmaceuticals (逸達生技; 6576 TW) announced on May 27, 2026, that its pivotal Phase 3 Casppian clinical trial evaluating FP-001 (Leuprolide Mesylate injectable emulsion, 42 mg) has successfully achieved Last Patient Last Visit (LPLV) across all global clinical sites. The trial successfully sustained its previously unblinded positive interim data profile, demonstrating that 94% of the pediatric intent-to-treat (ITT) cohort achieved absolute suppression of luteinizing hormone (LH) to target levels following a single, 6-month subcutaneous injection. The clinical datasets have been selected for oral/poster presentation at the upcoming ENDO 2026 Annual Meeting of the Endocrine Society.
The primary efficacy endpoint of the Casppian registration trial was defined as the proportion of pediatric patients maintaining down-regulated serum LH concentrations below 4 mIU/mL at 60 minutes post a simplified GnRHa stimulation challenge at Week 24. The final clinical readout yielded high statistical significance ($P = 0.0005$), with a 94% response rate that substantially surpassed the 80% success threshold mandated by the US FDA for Central Precocious Puberty (CPP) therapeutics.
- Safety and Tolerability Profile: The 42 mg formulation of FP-001 demonstrated a favorable tolerability matrix, with an adverse event (AE) profile consistent with established long-acting Gonadotropin-Releasing Hormone (GnRH) agonists, showing no unexpected systemic toxicity signals.
- Regulatory Roadmap and Ready-to-Use (RTU) Market Disruption: Following the successful execution of LPLV, Foresee has locked in a strict regulatory submission timeline. Dr. Ben Chien (簡銘達), Founder and Chairman of Foresee Pharmaceuticals, stated that the finalization of patient data collection marks the translation of clinical data into a high-value, near-term regulatory asset. The corporate strategy focuses on establishing FP-001 as the global first-in-class Ready-to-Use (RTU) stable liquid formulation requiring only a semi-annual (6-month) dosing interval, eliminating manual reconstitution errors common in legacy systems.
Foresee confirmed that the unblinded, audited datasets from the complete Phase 3 Casppian cohort are being compiled for publication in peer-reviewed pediatric endocrinology journals, alongside its upcoming profile presentation at ENDO 2026.
Resource:逸達兒童中樞性性早熟三期完成最後受試者訪視，年底前向FDA提交NDA
