Evecxia Completes Pre-IND Meeting with FDA for EVX-101 Depression Treatment

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. This meeting focused on the development of EVX-101, a new adjunctive treatment for patients suffering from depression who do not adequately respond to standard serotonin reuptake inhibitor treatments.

During the pre-IND meeting, Evecxia Therapeutics sought feedback and guidance from the FDA on various aspects, including non-clinical and clinical data and the design of a Phase 2 trial for EVX-101. The FDA reviewed the data and provided their responses in writing. One of the key outcomes of the meeting was the FDA's lack of concerns regarding the three months of GLP non-clinical safety data presented by Evecxia Therapeutics. This data is crucial as it supports the safety profile of EVX-101, especially considering the historical safety record of 5-hydroxytryptophan (5-HTP), the primary active ingredient in EVX-101.

The FDA also reviewed the safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase 1 trial of EVX-101 conducted on healthy volunteers. The findings from this trial did not raise any safety concerns and were deemed supportive of the subsequent Phase 2 trial. This positive feedback is a significant step forward for Evecxia Therapeutics as it aligns with the FDA on the submission of an IND to conduct a Phase 2 trial for EVX-101 in patients with depression.

Jacob Jacobsen, the CEO of Evecxia Therapeutics, expressed his satisfaction with the outcome of the pre-IND meeting. He emphasized the importance of the FDA's positive feedback as a milestone in the development of EVX-101, which could potentially provide a safer and more effective treatment option for millions of patients with mood disorders who do not respond adequately to first-line serotonin reuptake inhibitors.

EVX-101 is a unique, gastro-retentive, sustained-release tablet formulation of 5-HTP and low-dose carbidopa, which enhances the bioavailability of 5-HTP. The drug is being developed as an adjunctive therapy for depression and obsessive-compulsive disorder. The aim of adjunctive EVX-101 is to increase brain serotonin activity beyond what is achieved with serotonin reuptake inhibitors alone. Multiple published clinical studies support the safety and effectiveness of this serotonin augmentation approach in treating patients who do not respond adequately to serotonin reuptake inhibitors. However, this method is not currently used in any marketed antidepressants, making EVX-101 both novel and evidence-based.

5-HTP, the immediate precursor of serotonin, has shown therapeutic potential in various mood and central nervous system disorders according to numerous clinical reports. It is known for its benign safety profile. The therapeutic action of 5-HTP is based on Serotonin Synthesis Amplification, which creates a stronger and more resilient serotonin system in the brain. This pharmacological approach is different from that of available serotonin drugs such as serotonin reuptake inhibitors and psychedelics. However, the 5-HTP molecule itself is impractical for clinical use due to its minimal absorption and short-acting nature. No FDA-approved 5-HTP drugs currently exist. Evecxia Therapeutics is utilizing pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP, enabling practical Serotonin Synthesis Amplification therapy.

Evecxia Therapeutics is pioneering the development of Serotonin Synthesis Amplification for treating central nervous system disorders. Besides EVX-101, which is being developed for depression and obsessive-compulsive disorder, the company is also developing EVX-301 as a rescue therapy for patients hospitalized due to an acute suicidal crisis.