The Iris Trial

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.Study participation is currently limited to adults. At a future date, it is planned to enroll adolescents (ages 12-17 years) also.

•Age 12 to 45 at screening•Has a designated care/study partner who can reliably report on symptoms•Has a diagnosis of Autism Spectrum Disorder (ASD)•Has a body mass index (BMI) 18 through 34 kg/m², inclusive•Full scale IQ (or equivalent) ≥55 score•Psychoactive medications and adjunctive therapies are stable for 4 weeks prior toscreening•Must be able to swallow study medication

•Has Rett syndrome or Child Disintegrative Disorder•Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination)or device within 60 days prior to screening•History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening•History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5•If female, is pregnant or lactating