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) Division of Psychiatry, Office of Neuroscience, Center for Drug Evaluation and Research. This meeting is pivotal for the company, as it focuses on leveraging serotonin synthesis amplification to address central nervous system disorders.
The primary goal of the pre-IND meeting was to gather feedback and guidance from the FDA regarding non-clinical data, clinical data, and the design of a Phase 2 trial for EVX-101, a new adjunctive antidepressant aimed at patients with depression who do not respond adequately to first-line serotonin reuptake inhibitor therapy. The meeting was conducted through written correspondence.
The FDA reviewed the three-month GLP non-clinical safety data presented by Evecxia and raised no concerns. They also offered valuable insights into further non-clinical development of EVX-101, indicating that certain elements could be omitted due to the favorable historical safety profile of 5-hydroxytryptophan (5-HTP), the key active ingredient in EVX-101.
Additionally, the FDA had no objections to the safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase 1 trial involving healthy volunteers, affirming its support for proceeding to a Phase 2 trial.
The pre-IND meeting established alignment with the FDA for the submission of an IND application to initiate a Phase 2 trial of EVX-101 in patients with depression.
“We are thrilled with the outcome of the written responses from the FDA during the pre-IND meeting,” stated Jacob Jacobsen, CEO of Evecxia Therapeutics. “The encouraging feedback represents a significant milestone in our mission to develop EVX-101 as a potentially safer and more effective treatment option for the millions of patients suffering from mood disorders who do not adequately respond to first-line serotonin reuptake inhibitors.
