Monday, May 31, 2021
Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).
Moleac is dedicated in finding, developing and commercialising new medicines for the unmet medical needs of patients suffering from central nervous system diseases and injuries, such as stroke, TBI, and dementia.
The approval of this IND comes 3 years after the opening of the first IND by the U.S. FDA for MLC1501 in Post-Stroke Recovery, allowing Moleac to conduct a phase 1 study (safety study) in healthy volunteers which has been successfully completed.
"This approval represents another milestone for Moleac, supporting our ambition to provide best in class therapeutic options to patients in need. We are confident that MLC1501 will go through the several steps to be registered and marketed, making it available to the largest number of stroke and TBI victims in the near future. We would like to thank our colleagues and partners for their support, as this major step forward would have not been possible without their efforts and determination." David Picard, CEO of Moleac.
The road is now paved to prove the safety profile and the efficacy of MLC1501 on functional and neurological recovery in patients suffering from TBI. By succeeding with its drug development, Moleac would make a breakthrough in current treatment options to support patients with their recovery and reducing the overall burden of TBI.
TBI is defined as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury. It is one of the leading causes of disability worldwide and is affecting about 70 million people each year. A large number of TBI survivors suffers from disabilities causing a substantial impact on their day-to-day life and functioning, and represents a heavy financial burden on society.
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™). Clinical trials of MLC601/MLC901 showed benefit in improving functional and neurological recovery in patients having impairments after a Stroke or a TBI. In 2018, the U.S. FDA has approved an IND for MLC1501 in post-stroke recovery, the phase 1 was completed in 2020.
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. To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers' unaddressed needs. Moleac's neurorestorative natural formulation NeuroAiD™ reaches patients in more than 30 countries where it is regulated.
Clément Dif, Business Development & Marketing Department