Complete Announced during: Premarket · announced Mon 7:08a ET (premarket); before = Thu close; first trade Mon 7:46a ET; time = SEC 8-K acceptance
MapLight Therapeutics (Nasdaq: MPLT) reported topline results from a Phase 2 trial of ML-004 in autism spectrum disorder on June 22, 2026. The company said the trial did not meet its primary endpoint. ClinicalTrials.gov lists 168 enrolled participants (NCT05081245).
Trial details
- Drug
- ML-004Type Drug Route oral
- Treats
- Studied as a treatment for autism spectrum disorder.Condition Autism Spectrum Disorder
- Patients
- 168 patients (actual enrollment)2 arms · 29 sites in 3 countries
- Phase
- Phase 2
- Design
- Randomized, quadruple-blind, placebo-controlled, parallel-group
- Primary endpoint
- Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score (Baseline up to Day 110)
- Key secondary endpoints
- Change from Baseline in Clinician Global Impression of Improvement (CGI-I)
- Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score
- Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score
- Result
- Missed endpointThe study did not meet its primary endpoint of change from baseline to Week 12 in the caregiver-reported Autism Behavioral Inventory (ABI)–Social Communication Domain score.
- Safety
- “An effect size of this magnitude, particularly in those most severely affected, points to a clinically meaningful improvement and warrants further investigation of ML-004 in this population.” Safety and Tolerability ML-004 was generally well-tolerated, with treatment-emergent adverse events…
- Sponsor
- MapLight Therapeutics Nasdaq: MPLT
- Dates
- Study start Sep 13, 2022Primary completion Mar 10, 2026Announced Jun 22, 2026, 7:08 AM ET (SEC 8-K filing time)
- Trial ID
- NCT05081245 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, placebo-controlled, parallel-group Phase 2 trial (NCT05081245) tested ML-004 in Autism Spectrum Disorder. Studied as a treatment for autism spectrum disorder. It enrolled 168 patients across 2 arms at 29 sites in 3 countries. The primary endpoint was Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score (Baseline up to Day 110). MapLight Therapeutics reported that the trial did not meet its primary endpoint. The study started on Sep 13, 2022 and reached primary completion on Mar 10, 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.2)
- ClinicalTrials.gov record: NCT05081245
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