Moleac, a biopharmaceutical company, announced that the US 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.
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.” Prof Caplan added.
David Picard, CEO of Moleac, added, “The US FDA’s clearance of this IND is validating our collaborative and determined approach to move into registration trials for post-stroke recovery. We are confident and eager that this phase I study will confirm the safety of MLC1501 for starting as early as possible phase II with international stroke centers and patients. We are grateful to all our colleagues, our partners in academia and our corporate partners without whom this step forward would not have been possible.”
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. Clinical trials of MLC601/MLC901 and systematic reviews of those trials showed benefit in improving functional and neurological recovery, in patients having functional impairment after an acute ischemic stroke.
Moleac is a biopharmaceutical company dedicated in finding, developing and commercializing worldwide new medicines for the unmet medical needs of patients suffering of central nervous system (CNS) diseases and injuries, such as stroke, dementia and traumatic brain injuries.