Multi-pronged clinical evidence supports that Serotonin Synthesis Amplification can augment serotonin reuptake inhibitor (e.g., SSRI) therapeutic efficacy, safely

EVX-101 is a first-in-class Serotonin Synthesis Amplification antidepressant drug candidate

Historically, a clinical evidence foundation risk-mitigates psychiatric drug clinical development

Evecxia Therapeutics, Inc.—a clinical-stage neuroscience company developing a novel class of Serotonin Synthesis Amplification therapies—today announced the publication of the peer-reviewed article titled “Serotonin Synthesis Amplification to Augment the Therapeutic Efficacy of Serotonin Reuptake Inhibitor Antidepressants - Five Decades of Clinical Evidence” in the Journal of Clinical Psychopharmacology. The review article was co-authored with Dr. Stefania Chaikali, MD, MS, of the Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, and is freely available via open access (LINK).

Key Findings of the Article

• Serotonin reuptake inhibitors (e.g., SSRIs) appear to elevate human forebrain serotonin activity only modestly, which could be causal of their modest therapeutic efficacy.
• Adjunctive Serotonin Synthesis Amplification can elevate forebrain serotonin activity beyond the serotonin reuptake inhibitor effect.
• In clinical trials, Serotonin Synthesis Amplification therapy has shown encouraging antidepressant augmentation efficacy, with promising safety; but previous pharmacological approaches had limitations precluding clinical implementation.
• No FDA-approved antidepressant employs a Serotonin Synthesis Amplification pharmacology – Evecxia’s EVX-101 would be the first.

“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.”

About EVX-101

EVX-101 is an oral, gastro-retentive, sustained-release tablet formulation of 5-HTP (the natural immediate precursor to serotonin) and low-dose carbidopa (multiplies 5-HTP’s bioavailability). EVX-101 is designed to produce sufficient and sustained 5-HTP plasma levels, resulting in sufficient and sustained Serotonin Synthesis Amplification, elevation of serotonin activity beyond the SSRI effect, and augmentation of SSRI efficacy. In Phase 1 clinical studies, EVX-101, as adjunctive to SSRI therapy, transformed 5-HTP’s pharmacokinetic (PK) profile and demonstrated evidence of elevation of forebrain serotonin activity beyond the SSRI effect - with a favorable safety and tolerability profile.

About Evecxia Therapeutics

Evecxia is the first Company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification—building a stronger, more resilient brain serotonin system—to treat psychiatric indications. Evecxia’s lead candidate EVX-101 is being developed as next-line oral adjunctive (add-on) therapy for obsessive-compulsive disorder (OCD) and depression patients for whom monotherapy with first-line serotonin reuptake inhibitor antidepressants (e.g., SSRIs such as Prozac®) yields inadequate therapeutic relief.

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No FDA-approved antidepressant employs a Serotonin Synthesis Amplification pharmacology – Evecxia’s EVX-101 would be the first