RESEARCH TRIANGLE PARK, N.C. — Evecxia Therapeutics Inc. said it has published a peer-reviewed article reviewing clinical evidence supporting EVX-101 as a potential adjunctive therapy for psychiatric diseases.
The clinical-stage neuroscience company is developing Serotonin Synthesis Amplification therapies, a novel drug class intended to increase serotonin activity and augment the efficacy of serotonin reuptake inhibitors, including SSRIs.
The article, titled “Serotonin Synthesis Amplification to Augment the Therapeutic Efficacy of Serotonin Reuptake Inhibitor Antidepressants – Five Decades of Clinical Evidence,” was published in the Journal of Clinical Psychopharmacology. It was co-authored with Dr. Stefania Chaikali, MD, MS, of the Department of Psychiatry at Massachusetts General Hospital and Harvard Medical School.
Evecxia said the review found that serotonin reuptake inhibitors appear to raise human forebrain serotonin activity only modestly, which may contribute to their limited therapeutic efficacy. The company said the article also found that adjunctive Serotonin Synthesis Amplification could increase forebrain serotonin activity beyond the effect of serotonin reuptake inhibitors.
According to Evecxia, prior clinical trials of Serotonin Synthesis Amplification therapy have shown encouraging antidepressant augmentation efficacy and promising safety, though earlier pharmacological approaches had limitations that prevented clinical implementation.
The company said no FDA-approved antidepressant currently uses Serotonin Synthesis Amplification pharmacology. Evecxia said EVX-101 would be the first if approved.
“Discovering novel psychiatric drugs is difficult, as animal models of psychiatric disease fail to predict human therapeutic efficacy,” said Jacob Jacobsen, PhD, Chief Executive Officer and Co-founder of Evecxia Therapeutics. “EVX-101 is supported by multipronged clinical evidence, which historically risk-mitigates Phase 2/3 development in psychiatry. Indeed, 100% of FDA-approved psychiatric drugs are founded in primary clinical evidence.”
EVX-101 is an oral, gastro-retentive, sustained-release tablet formulation of 5-HTP, the natural immediate precursor to serotonin, and low-dose carbidopa, which is intended to increase 5-HTP bioavailability.
Evecxia said the drug candidate is designed to produce sufficient and sustained 5-HTP plasma levels, resulting in sustained Serotonin Synthesis Amplification, increased serotonin activity beyond the SSRI effect and improved SSRI efficacy.
In Phase 1 clinical studies, Evecxia said EVX-101, when used as an adjunct to SSRI therapy, transformed 5-HTP’s pharmacokinetic profile and showed evidence of increased forebrain serotonin activity beyond the SSRI effect, with a favorable safety and tolerability profile.
