- Enrollment completed in ML-007C-MA’s ZEPHYR Phase 2 trial in schizophrenia
- Last patient visit completed for ML-004’s IRIS Phase 2 trial in autism spectrum disorder
- Topline results from both Phase 2 trials expected by mid-August 2026
SAN FRANCISCO and BOSTON, May 01, 2026 (GLOBE NEWSWIRE) — MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today announced completion of enrollment in its Phase 2 ZEPHYR trial evaluating ML-007C-MA for the treatment of schizophrenia. 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
About MapLight Therapeutics
MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The Company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The Company’s discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation.
For more information, please visit www.maplightrx.com.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including the Company’s expectations regarding the potential benefits of its current and future product candidates and programs, and the anticipated timing of results from the Company’s Phase 2 ZEPHYR and Phase 2 IRIS clinical trials. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in the Company’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the Company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the Company’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the risk that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials; the timing or likelihood of regulatory filings and approvals; expectations regarding the Company’s ability to fund its current operations; and other risks and uncertainties identified in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2026, and subsequent disclosure documents the Company may file with the SEC. The Company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
For investor inquiries: investors@maplightrx.com
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