RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced that the U.S. Patent and Trademark Office has allowed U.S. patent application 17/877,699.
The allowed claims cover the composition of EVX-101, a bilayer tablet comprising one swelling layer, providing gastro-retention, and one modified release layer, providing parallel sustained-release of 5‑hydroxytryptophan (5-HTP) and low-dose carbidopa. The claims further cover specific physical characteristics, excipients, 5-HTP and carbidopa doses, in vitro dissolution profiles, and human in vivo pharmacokinetics profiles.
EVX-101 is a novel, proprietary gastro-retentive, sustained-release tablet formulation of 5-HTP, the natural precursor to serotonin, and low-dose carbidopa. EVX-101 will enable, for the first time, to realize the full therapeutic potential of serotonin synthesis amplification. EVX-101 is in clinical development for adjunctive therapy in major depressive disorder patients responding inadequately to first-line serotonin reuptake inhibitor antidepressants.
“In a Phase 1 trial EVX-101 demonstrated the ability to provide sustained and adequate 5-HTP exposure while ensuring safety and tolerability. The allowed patent is a cornerstone in our portfolio of issued and pending patents covering EVX-101,” stated Jacob Jacobsen, Ph.D., Chief Scientific Officer of Evecxia.
The patent to be issued from U.S. patent application 17/877,699 is wholly owned by Evecxia Therapeutics and has a current expiry of 2042.
About Evecxia Therapeutics
Evecxia’s mission is to help patients suffering from disabling neuropsychiatric conditions for which current therapies are inadequate. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders. Serotonin synthesis amplification differs from targeting serotonin transporters (e.g., SSRIs) and receptors (e.g., psilocybin). Evecxia deploys 5-HTP, the natural serotonin precursor, delivered via proprietary drug delivery technologies to achieve sustained serotonin synthesis amplification. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy in acute suicidal crisis. Evecxia holds a comprehensive portfolio of issued and pending patents on the 5-HTP sustained-release/serotonin amplification method, doses, formulations, and related technologies.
For additional information about Evecxia, please visit www.evecxia.com.