Moleac announced the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of MLC1501, as a first step of a clinical program in post-stroke recovery treatment. Approval of this IND enables Moleac to initiate a safety study of MLC1501 in normal subjects as part of the overall clinical development plan for demonstrating that MLC1501 improves functional independence and recovery of motor, speech, cognition and other neurological dysfunctions in post-acute ischemic stroke (AIS) survivors having not recovered after acute treatments (thrombolysis, thrombectomy) or having not received them. Beyond the acute phase, there are no available treatments, other than rehabilitation measures, to relieve the disabilities suffered by stroke survivors. Proving clinical safety and efficacy of MLC1501 on long-term functional and neurological recovery in patients suffering from AIS will fill a therapeutic gap and help reduce the overall burden of stroke.
"This is a clear milestone for Moleac to commence development of MLC1501 an agent that has proven successful in Asia for use in the USA as a new treatment for post-stroke recovery, an area where we need more agents to reduce the devastating burden of stroke for patients and their families," said professor Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University. "We already have learned much about the properties of the parent compound, NeuroAiD. This information will guide the clinical development of MLC 1501, and trials of its use in the USA."