The Company also announced completion of the final patient visit in its Phase 2 IRIS trial evaluating ML-004 for the treatment of autism spectrum disorder. The Company expects to report topline results from both Phase 2 trials by mid-August 2026.

"The robust enrollment in the ZEPHYR trial reflects the critical unmet need for new treatment options in schizophrenia," said Chris Kroeger, Co-Founder and Chief Executive Officer. "We are grateful for the enthusiasm and commitment of both participants and investigators that enabled efficient study conduct while maintaining high quality standards. 2026 is shaping up to be an important year for MapLight and we look forward to sharing the topline data from these trials."

The Phase 2 ZEPHYR trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-007C-MA in inpatient adult participants with schizophrenia experiencing an acute exacerbation of psychosis.

  • 307 participants in the trial were randomized 1:1:1 to receive either placebo, ML-007C-MA 210/3 mg twice daily, or ML-007C-MA 330/6 mg once daily
  • Primary endpoint is the change in PANSS total score from baseline to Week 5
  • Key secondary endpoints include change in CGI-S score, PANSS-Marder positive and negative factor scores from baseline to Week 5
  • Exploratory endpoints include change in cognitive function, assessed across multiple domains commonly impacted in schizophrenia, from baseline to Week 5

The Phase 2 IRIS trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of ML-004 in adults and adolescents with autism spectrum disorder.

  • 161 participants were randomized in the trial, consistent with our enrollment target of over 100 adolescents (aged 12-17)
  • Primary endpoint is the change in Autism Behavioral Inventory (ABI)-Social Communication Domain Score from baseline to Week 12
  • Key secondary endpoints include change in CGI-I, ABI-C and Aberrant Behavior Checklist-Irritability (ABC-I) score from baseline to Week 12