Evecxia Therapeutics is developing EVX-101 as an adjunctive (add-on augmentation) therapy for patients with depression responding inadequately to first-line SSRI/SNRI antidepressants monotherapy. EVX-101 is a proprietary, oral tablet, gastroretentive, slow-release formulation of 5-HTP and low-dose carbidopa. EVX-101 uses a novel embodiment of a validated gastroretentive drug delivery technology, used in 7 FDA-approved drug products. The gastroretentive technology ensures delivery of 5-HTP and carbidopa over about 8-10h to the site of 5-HTP absorption, the upper intestine. The low-dose carbidopa protects 5-HTP against first-pass metabolism (degradation) over the intestinal wall, manyfold increasing the oral bioavailability of 5-HTP.
When added to existing SSRI/SNRI antidepressant therapy, adjunctive EVX-101 will amplify serotonin neurotransmission beyond the antidepressant effect, which clinical data suggest will augment the antidepressant response in patients inadequately treated by antidepressant monotherapy.
EVX-101 can be taken by the patient at home, with breakfast and dinner. EVX-101 is expected to be free of abuse potential and therefore not considered a controlled substance by the US Drug Enforcement Agency.
EVX-101, adjunctive or as monotherapy, could have therapeutic relevance in additional important unmet needs in Psychiatry e.g. OCD, and in other disorders of the brain. Other Mental Disorders
EVX-101 is protected by a portfolio of issued and pending patents, in the US as well as all major overseas markets.
Evecxia Therapeutics is developing EVX-301 as a rescue therapy for patients in acute suicidal crisis. EVX-301 is a proprietary intravenous 24h infusion of 5-HTP. EVX-301 is designed to quickly and optimally amplify brain extracellular serotonin and hence serotonin neurotransmission. Convergent clinical data suggest this will impart an anti-suicidal effect, comprised of improved mood, sociability, and calmness, and reduced aggression and impulsivity.
The patient will receive EVX-301 in the clinic or hospital. Evecxia expects that EVX-301 can be a stand-alone therapy or be the first step in a novel treatment algorithm, the second step being transfer to maintenance suicide prevention therapy with EVX-101.
In clinical trials, 5-HTP has directly shown direct therapeutic potential in a spectrum of psychiatric, neurological, endocrinological, and developmental disorders. Further, there are rationales for that appropriate 5-HTP drugs could treat yet other disorders.
Evecxia is actively exploring additional indications for EVX-101 and EVX-301 and additional drug candidates utilizing 5-HTP as the active compound.