Evecxia Therapeutics Announces Positive Phase 1b Clinical Trial Results for Serotonin Synthesis Amplification Therapy
Evecxia Therapeutics, a clinical-stage neuroscience company, has announced positive data from its Phase 1b PK/PD trial for brain serotonin target engagement. The trial focused on depression patients already undergoing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. The study demonstrated that EVX-301, an intravenous infusion of 5-HTP, successfully entered the brain, elevated biomarkers of serotonin synthesis, and increased serotonin activity beyond the effects of existing SSRI/SNRI treatments. These findings corroborate the target 5-HTP plasma exposure of approximately 100 ng/mL, which is considered the putative therapeutic target. The adjunctive EVX-301 treatment was generally well-tolerated, with most adverse events being mild or moderate and consistent with increased brain serotonin activity. The trial was conducted at PARC Clinical Research in Adelaide, Australia.