NOVATECH Co. Ltd

Marvel Biosciences Corp. has signed a letter of intent with Novatech, the Asia-Pacific full-service clinical CRO, to run the Phase 1 trial of its lead drug candidate MB-204, marking the company's transition from a preclinical to a clinical-stage developer. The planned Phase 1 program is designed to establish the initial safety, tolerability and pharmacokinetic profile of MB-204 in humans, supported by preclinical findings showing immediate, robust and durable effects, including measurable carry-over effects after treatment stopped, across multiple mouse models relevant to neurodevelopmental disorders including Oprm1, Rett and Fragile X. The single ascending dose study is expected to begin in Q4 of 2026 and will test safety, tolerability and pharmacokinetics as well as include a potential biomarker and several cognitive endpoints, with its data informing the design of the subsequent multiple ascending dose study. The trial will be conducted in Australia, which Marvel CEO Rod Matheson cited for its streamlined regulatory environment and a generous 43% tax credit, and the company has already developed a novel liquid-based formulation of MB-204 for the SAD study with a grant from the National Research Council of Canada. Marvel is also planning an upcoming experiment with the iBrain Inserm Lab to test MB-204 against Yamo Pharmaceuticals' L1-79 in a mouse model of autism, following L1-79's recent efficacy in a Phase 2 study.