Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Stroke Recovery
Mar 04, 2018 SINGAPORE, March 5, 2018 /PRNewswire/ -- Moleac, a biopharmaceutical company 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. 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...
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