FDA approves IND application for Moleac’s Phase 1 study MLC1501

Biopharmaceutical company, Moleac that is focused on research and development of new medicines for central nervous system (CNS) diseases and injuries, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of MLC1501, as first step of a clinical programme in post-stroke recovery treatment.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.

Professor Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University said “This is a clear milestone for Moleac to commence development of MLC1501 an agent that has proven successful in Asia for use in the USAas 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.”

MLC1501 is a further developed formulation consisting of four of the original nine herbs that are present in two parent formulations, MLC601 and MLC901 (NeuroAiD™). Pharmacological studies have demonstrated equivalent neuroprotective and neurorestorative properties of MLC1501 in nonclinical animal and cellular models of focal ischemia.