Sage Group Advises Evecxia on Licensing of EVX-101, a Novel Treatment for Depression and OCD Using Serotonin Synthesis Amplification

Evecxia deploys 5-hydroxytryptophan, 5-HTP, to achieve Serotonin Synthesis Amplification. 5-HTP amplifies brain serotonin and have shown antidepressant potential in dozens of human studies. However, native 5-HTP is impractical as a drug due to poor oral bioavailability and short plasma half-life. No FDA/EMA-approved 5-HTP drug product exists. Evecxia utilizes propriety drug delivery technologies to enable sufficient and sustained 5-HTP exposure, thereby realizing the practical therapeutic potential of 5-HTP and Serotonin Synthesis Amplification.

Evecxia has two clinical stage products in development: EVX-101, a gastroretentive sustained-release tablet of 5-HTP and low-dose carbidopa, and EVX-301, a 24-hour 5-HTP infusion.

Evecxia’s lead product EVX-101 is Phase 2-ready. Phase 1 studies found excellent safety and acceptable tolerability. EVX-101 is being developed as adjunctive augmentation therapy for patients with inadequate response to first-line antidepressant monotherapy, e.g., SSRIs. 

Initial indications include depression and obsessive-compulsive disorder (OCD). The U.S. patient populations for these indications are estimated at 7 million and 1 million respectively. EVX-301 is being developed for patients hospitalized with suicidal ideation, with a US patient population estimated to be approximately 1 million.

Administered adjunctively, EVX-101 amplifies extracellular serotonin—and hence brain serotonin activity—beyond the effect of a first-line antidepressant, which dozens of clinical depression studies support augment antidepressant efficacy. EVX-101 would be safe, have no abuse potential, have therapeutic potential across mood disorders, and as a tablet be easy to prescribe and administer at home. Thus, EVX-101 could make a large positive impact on depression and mood disorder therapy.

First line treatments currently approved for patients with depression and OCD only provide adequate treatment for approximately 30% of patients. Next-line antidepressants (i.e., atypical antipsychotics) have modest efficacy with metabolic, motoric and endocrine safety concerns. EVX-101 could be a safer, more effective, and scalable next-line treatment for these patients.

Sage Group is seeking licensing/commercialization partners for EVX-101.