Evecxia Therapeutics has announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of EVX-101 for depression. The FDA's feedback supports the advancement of EVX-101, a novel adjunctive antidepressant candidate, into a Phase 2 clinical trial for patients who do not respond adequately to first-line serotonin reuptake inhibitor (SRI) monotherapy.
The pre-IND meeting, conducted through written responses, focused on the non-clinical and clinical data, as well as the Phase 2 trial design for EVX-101. The FDA's Division of Psychiatry, Office of Neuroscience, Center for Drug Evaluation and Research provided valuable guidance on the development program.
FDA Feedback on Safety and Development
The FDA expressed no concerns regarding the presented three-month GLP non-clinical safety data. They also offered guidance on streamlining further non-clinical development, suggesting elements that could be omitted based on the favorable historical safety record of 5-hydroxytryptophan (5-HTP), the key active pharmaceutical ingredient in EVX-101.
Furthermore, the FDA had no concerns regarding the safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase 1 trial of adjunctive EVX-101 in healthy volunteers, supporting its progression to a Phase 2 trial.
EVX-101: A Novel Approach to Depression Treatment
EVX-101 is a first-in-class, proprietary gastro-retentive, sustained-release tablet formulation of 5-HTP and low-dose carbidopa, designed to amplify serotonin synthesis in the brain. It is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder (OCD) in patients who have an inadequate response to first-line SRIs.
The rationale behind EVX-101 is to elevate brain serotonin activity beyond what is achieved with SRI monotherapy. Clinical studies suggest that this serotonin augmentation strategy can be safe and effective in treating depression patients who do not respond adequately to SRIs. All current marketed antidepressants are based in clinical evidence.
Serotonin Synthesis Amplification
5-HTP, the immediate precursor to serotonin, has shown therapeutic potential in mood and other central nervous system disorders. Evecxia is utilizing pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP in the body, enabling practical Serotonin Synthesis Amplification therapy.
"We are delighted with the outcome of the pre-IND meeting written responses from the FDA," said Jacob Jacobsen, CEO of Evecxia Therapeutics. "The positive and helpful feedback from the FDA is a significant milestone for our development program to develop EVX-101 as a potentially safer and more effective option for the millions of mood disorder patients not responding adequately to first-line serotonin reuptake inhibitors."
