• The proportion of patients with serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24 was 94%, and the results were statistically significant (P-value = 0.0005), which exceeded the pre-specified success criterion.
• Leuprolide mesylate 42mg injection (FP-001) was well tolerated in patients with Central Precocious Puberty (CPP)

Foresee Pharmaceuticals announced positive topline results from its Phase 3 Casppian clinical trial evaluating the efficacy and safety of FP-001 42 mg (leuprolide mesylate), an investigational, sustained-release GnRH agonist, administered every six months in children with Central Precocious Puberty (CPP).

The study's primary endpoint was defined as the percentage of patients with serum LH concentrations < 4 mIU/mL at 60 minutes following an abbreviated GnRHa stimulation test at Visit 5 (Week 24). The study successfully met its primary efficacy endpoint, with statistically significant results (P-value = 0.0005), demonstrating that 94% of patients had serum luteinizing hormone (LH) suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24, and exceeded the pre-specified success criterion.

FP-001 42 mg injection was well tolerated and considered effective for the treatment of CPP if ≥80% of patients exhibited this level of LH suppression. The study results convincingly achieved this threshold.

"We are incredibly encouraged by these pivotal results, which confirm the ability of a single injection of FP-001 42 mg (GnRHa) to provide effective and sustained suppression of the pituitary-gonadal axis for a full six months. Meeting this rigorous primary endpoint with such a high threshold of 94% is a significant milestone. It underscores the potential of FP-001 to offer a meaningful new treatment option, potentially improving convenience and adherence of children with CPP." Stated Bassem Elmankabadi, M.D. Senior Vice President, Clinical Development

"The safety profile of FP-001 42 mg observed in the study was consistent with the established class profile of GnRH agonists. The most common adverse events remained unchanged from those observed in earlier studies and were typically mild to moderate in severity. This outcome moves us nearer to our objective of providing safe and effective treatments for children in need." Stated Yisheng Lee, M.D. Chief Medical Officer

"The consistent safety profile, coupled with the robust efficacy data, strengthens our confidence in FP-001 as a potential best-in-class therapy," added Dr. Ben Chien, PhD. The chairman and CEO. "We extend our sincere gratitude to the patients, families, and investigators who participated in this important study."

Full results from the Phase 3 trial will be submitted for presentation at an upcoming scientific conference. Foresee Pharmaceuticals plans to engage with global regulatory authorities to discuss the submission of a New Drug Application (NDA) by mid-2026.