• No concerns raised regarding presented non-clinical or clinical safety data

• Meeting provides clear path forward for filing an IND for conducting a Phase 2 trial in depression patients responding inadequately to standard of care

Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat central nervous system disorders—today announced the 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.

FDA Feedback & Guidance

The focus of the pre-IND meeting was to receive FDA feedback and guidance on the non-clinical data, clinical data, and Phase 2 trial design for EVX-101, a novel adjunctive antidepressant candidate for depression patients responding inadequately to first-line serotonin reuptake inhibitor monotherapy. The pre-IND meeting was completed through written responses.

The FDA expressed no concerns regarding the three months GLP non-clinical safety data presented and provided useful guidance on further non-clinical development of EVX-101, including on elements that can be omitted, given the favorable historical safety record on 5‑hydroxytryptophan (5‑HTP), the key active pharmaceutical ingredient in EVX-101.

The FDA expressed no concerns regarding the safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase 1 trial of adjunctive EVX-101 in healthy volunteers, in terms of supporting a subsequent Phase 2 trial.

The pre-IND meeting enabled alignment with the FDA regarding submission of an IND to conduct a Phase 2 trial of EVX-101 in depression.

“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.”

About EVX-101

EVX-101 is a first-in-class, proprietary gastro-retentive, sustained-release tablet formulation of 5‑hydroxytryptophan (5-HTP), the immediate precursor to serotonin, and low-dose carbidopa (multiplies 5-HTP’s bioavailability). EVX-101 is in development for next-line adjunctive therapy in depression and obsessive compulsive disorder.

Adjunctive EVX-101 is intended to elevate brain serotonin activity beyond the effect of first-line serotonin reuptake inhibitor monotherapy. Multiple published clinical studies support this serotonin augmentation pharmacology is safe and effective in treating depression patients responding inadequately to serotonin reuptake inhibitors (1-4); but, it is not used in any marketed antidepressants. Hence, EVX-101 for depression is risk-mitigated, as based in clinical evidence, yet novel. All marketed antidepressants are based in clinical evidence.

EVX-101 appears safe and devoid of abuse potential and could be scalable to broad outpatient mood disorder care.

About 5-HTP

5-HTP is the immediate precursor of the neurotransmitter serotonin. Decades of clinical reports support a consensus that 5-HTP has demonstrated therapeutic potential in mood and others central nervous system disorders (5-7). 5-HTP has a benign human safety record (6, 8). 5-HTP’s putative therapeutic action is via Serotonin Synthesis Amplification, creating a stronger, more resilient brain serotonin system, a pharmacology distinct from available serotonin drugs, e.g., serotonin reuptake inhibitors and psychedelics. But the 5-HTP molecule is impractical for clinical practice, as 5-HTP is minimally absorbed by the body and very short-acting (9). No FDA-approved 5-HTP drug exists. Evecxia deploys pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP in the body, thus enabling practical Serotonin Synthesis Amplification therapy.

About Evecxia Therapeutics

Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat central nervous system disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder when first-line serotonin reuptake inhibitor antidepressants alone are inadequate. EVX-301 is being developed as rescue therapy for patients hospitalized for acute suicidal crisis.

For additional information about Evecxia, please visit www.evecxia.com.

References

1. van Praag HM (1982): Adv Biochem Psychopharmacol. 34:259-286.

2 Nardini M, et al. (1983): Int J Clin Pharmacol Res. 3:239-250.

3. Walinder J, et al. (1976): Arch Gen Psychiatry. 33:1384-1389.

4. Papakostas GI, et al. (2012): Am J Psychiatry. 169:1267-1274.

5. Shaw K, et al. (2002): Cochrane Database Syst Rev.CD003198.

6. Turner EH, et al. (2006): Pharmacol Ther. 109:325-338.

7. Levy A, et al. (2016): Curr Treat Options Neurol. 18:21.

8. Das YT, et al. (2004): Toxicol Lett. 150:111-122.

9. Evecxia (2024): Data on file.

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