Evecxia Therapeutics Reports Favorable Data From a Phase 1 Single-Ascending Dose and Multiple-Ascending Dose Trial of Adjunctive EVX-101 in Healthy Volunteers Treated With a First-Line Antidepressant
April 10, 2023 - Evecxia Therapeutics, Inc. announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram. The Company further announced the planned design of a Phase 2 adjunctive EVX-101 trial in patients with major depressive disorder (MDD) responding inadequately to a first-line antidepressant (selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)).
EVX-101 is a novel, proprietary gastro-retentive, sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin, and low-dose carbidopa. EVX-101, administered in addition to a first-line antidepressant, is intended to elevate extracellular serotonin beyond the first-line antidepressant effect, which convergent clinical pharmacology, brain imaging, and neuroanatomical data support would augment antidepressant efficacy. In EVX-101, the 5-HTP dose is fixed at 250 mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.
The Phase 1 trial was conducted at Quotient Sciences’ Nottingham, UK facility.