Marvel Bioscineces Corp. (MRVL) has signed a letter of intent with Novatech to support the planned Phase 1 clinical trial of MB-204, marking the company's transition from preclinical development into human studies.
Marvel is developing MB-204 for autism spectrum disorder and related neurodevelopmental conditions. The therapy has shown encouraging results in preclinical studies, including effects in animal models of Rett syndrome and Fragile X syndrome.
Under the agreement, Novatech, a contract research organization focused on clinical trial management, will support the Phase 1 program, which is expected to be conducted in Australia. The study is intended to establish the initial safety, tolerability and pharmacokinetic profile of MB-204 in humans.
As part of a corporate update, Marvel said the Phase 1 single ascending dose (SAD) study is expected to begin in Q4 2026. The trial is designed to evaluate safety, tolerability and pharmacokinetics while also assessing a potential biomarker and several cognitive endpoints. Data from the study are expected to help guide the design of a subsequent multiple ascending dose (MAD) trial.
The company noted that the planned clinical program follo...