EVX-301 / Evecxia - LARVOL DELTA

N/A: An 18-participant study in depressed patients collecting CSF (Cerebrospinal fluid) to study the pharmacodynamic biomarkers of EVX-301 (L-5 Hydroxytryptophan in Saline) over a 24 hour infusion period. (ANZCTR) - P1/2 | N=18 | Not yet recruiting | Sponsor: Evecxia Therapeutics, Inc. | N=12 ➔ 18

Biomarker • Enrollment change • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Phase 1 Trial of Single Ascending 24h IV Infusion Doses of EVX-301 (5-HTP) in Healthy Adult Subjects Taking Escitalopram: Confirmation of Target Engagement and Phase 2 Dose (ASCP 2024) - "EVX-301 met the goals of this phase 1 study: dose-proportional PK with low inter-subject variability; target 5-HTP plasma levels achieved quickly and PD biomarker data indicative of target engagement at all dose levels. Mild-moderate AEs judged related to EVX-301 were encountered at higher doses. The constant rate 1 mg/kg dose was selected for study in an upcoming Ph2a exploratory adjunctive treatment study in MDD patients with subacute suicidal ideation."

Clinical • P1 data • P2 data • CNS Disorders • Psychiatry • Suicidal Ideation