Evecxia Therapeutics Posts Favorable Data from Phase I Trial of Adjunctive EVX-101 for Major Depression Disorder
By Alex Keown
April 12, 2023
An experimental antidepressant is showing early promise as an adjunctive therapeutic for major depressive disorder in an early-stage clinical trial.
Evecxia Therapeutics, based in Research Triangle Park, posted favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial assessing EVX-101 in healthy volunteers treated with escitalopram, a selective serotonin reuptake inhibitor (SSRI). The company is planning a Phase II trial. The mid-stage study will evaluate EVX-101 in patients with Major Depressive Disorder who inadequately respond to first-line antidepressant therapy.
This was the second Phase I study of EVC-101 completed by Evecxia.
EVX-101 is a novel, gastro-retentive, sustained-release tablet formulation of both 5-hydroxytryptophan (5-HTP), which is the natural precursor to serotonin, and low-dose carbidopa, a Parkinson’s disease therapeutic. EVX-101 is administered alongside a first-line antidepressant. According to company data, when EVX-101 is added to existing SSRI/SNRI first-line antidepressant therapies, the experimental medicine is designed to amplify serotonin neurotransmission beyond the antidepressant effect. Data suggest the combination approach will augment the antidepressant response in patients inadequately treated by antidepressant monotherapy, the company said.
Data from the Phase I study showed putative therapeutic 5-HTP plasma exposures were achieved at all dose levels evaluated. Additionally, Evecxia noted that pharmacodynamic biomarker data in the study demonstrated target engagement, which was indicative of brain extracellular serotonin elevation beyond the first-line antidepressant effect.
No dose levels of EVX-101 evaluated in the early-stage study were associated with significant changes in clinical labs, vital signs, or ECGs. No serotonin toxicity or other safety signals were reported. Dose titration of EVX-101 substantially improved tolerability, the company added.
Joseph Patti, president and chief executive officer of Evecxia, expressed excitement about the Phase I results and the awaiting Phase II study.
“We are excited to advance our lead candidate for the adjunctive treatment of patients suffering from disabling symptoms of depression despite receiving antidepressant treatment. EVX-101 could serve a large outpatient population not helped by available treatment options,” Patti said in a brief statement.
The Phase II study is expected to be a six-week program. In the trial, EVX-101 will be evaluated in a double-blind, placebo-controlled study. The trial is expected to include approximately 200 adults with moderate to severe depression responding inadequately to current first-line antidepressant SSRI therapy, according to the company.
When the trial begins, efficacy of EVX-101 will be assessed through validated psychometric scales used in the detection of changes in depressive symptoms, according to the company. Safety, tolerability, PK, and exploratory precision medicine-based endpoints will also be evaluated at various time points during the study. Best practices will be employed to ensure the quality and integrity of the EVX-101 Phase II trial, the company said.
The Phase II study is expected to begin sometime in the first part of 2024, Evecxia reported on its website.
Beyond MDD, the company believes EVX-101, either taken as an adjunctive or as monotherapy, could have therapeutic relevance in additional important unmet needs in multiple disorders of the brain.
In addition to EVX-101, Evecxia is also developing EVX-301 as a rescue therapy for patients hospitalized for acute suicidal ideation crisis. The company plans to initiate a Phase IIa study of adjunctive EVX-301 in depression patients in the latter half of 2023. The study will evaluate the experimental medicine in a study of individuals with inadequate response to first-line antidepressants and ongoing suicidal ideation.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
