The proprietary 5-HTP chemical synthesis and drug substance is expected to secure 5-HTP commercial supply and augment Evecxia's patent portfolio

Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders—today announced the filing of a provisional patent on chemical synthesis of 5-hydroxytryptophan (5‑HTP).

5-HTP is the natural immediate precursor of the neurotransmitter serotonin. Decades of clinical reports support a consensus that 5-HTP has demonstrated therapeutic potential in mood and others CNS disorders (1-3). 5-HTP has a benign human safety record (2, 4). 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 (5). Evecxia deploys pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP in the body, thus enabling practical Serotonin Synthesis Amplification therapy.

Today, available 5-HTP is extracted from Griffonia simplicifolia, harvested in the wild in West Africa. Griffonia cultivation attempts have failed. Habitat degradation and overharvesting may threaten future botanical 5-HTP supply (6).

To ensure future 5-HTP supply and control its quality and manufacture, Evecxia has developed a novel and simple chemical synthesis process for 5-HTP, comprising steps consistent with scalability to commercial drug substance manufacture. A provisional patent has been filed protecting the process and chemically synthesized 5-HTP. Jacob Jacobsen, Evecxia's CEO, stated, "Risk-mitigation is Evecxia's lodestar. We are pleased we successfully established proof-of-concept for securing future 5‑HTP drug substance supply. Patents pertaining to drug substance manufacture and solid forms are critical in pharmaceutical intellectual property. The new patent would augment Evecxia's portfolio of issued and pending patents, which we expect to protect our drug candidates EVX-101 and EVX-301 well into the 2040s."

About Evecxia Therapeutics

Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS 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 (OCD) when first-line serotonin reuptake inhibitor (SSRI/SNRI) antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients hospitalized for acute suicidal crisis.

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

References

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

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

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

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

5. Evecxia (2024): Data on file.

6. Cunningham AB, et al. (2021): J Ethnopharmacol. 278:114202.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240723309600/en/

Risk-mitigation is Evecxia's lodestar. We are pleased we successfully established proof-of-concept for securing future 5 HTP drug substance supply. The new patent would augment Evecxia's portfolio of issued and pending patents...