Biopharmaceutical company MapLight Therapeutics, Inc. (MPLT) announced Monday that the IRIS Phase 2 trial did not meet its primary endpoint in social communication deficits associated with autism spectrum disorder (ASD).
IRIS (ML-004-002) is a Phase 2 study of ML-004 in ASD. The study randomized 161 participants (102 adolescents, 59 adults), with prespecified analyses planned by age group and baseline irritability severity.
As an exploratory signal-finding Phase 2 study, IRIS was explicitly designed to test multiple clinical endpoints based on preclinical findings, including social communication and irritability, and to identify the most appropriate development path forward.
The 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.
Social communication is a domain for which no approved pharmacologic therapies exist, and for which validated, treatment-sensitive outcome measures remain an area of active scientific investigation.
However, in a prespecified analysis of adolescents (age 12-17) with moderate or greater baseline irritability, ML-004 demonstrated a clinically meaningful improvement in irritability over placebo.
Consistent with this finding, clinically meaningful improvement over placebo was observed on the Clinician Global Impression-Improvement (CGI-I)-Irritability domain in the adolescent population randomized with moderate or greater baseline irritability.
ML-004 was generally well-tolerated, with no severe or serious adverse events in the active treatment arm.
Following a full review of the data, the Company expects to engage with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting to determine the clinical development path forward.
In Wednesday's pre-market trading, MPLT is trading on the Nasdaq at $25.79, down $3.03 or 10.51 percent.
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