Foresee Pharma Reports Positive Topline Results From Phase 3 Casppian Trial With FP-001

(RTTNews) - Foresee Pharmaceuticals (6576.TWO) announced positive topline results from Phase 3 Casppian trial evaluating the efficacy and safety of FP-001 42 mg, an investigational, sustained-release GnRH agonist, administered every six months in children with Central Precocious Puberty. The company said the proportion of patients with serum luteinizing hormone suppression to < 4 mIU/mL at 60 minutes following a GnRHa stimulation test at Week 24 was 94%, and the results were statistically significant, which exceeded the pre-specified success criterion. FP-001 42 mg injection was well tolerated.

"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," said Bassem Elmankabadi, Senior Vice President, Clinical Development.

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