Aclipse Therapeutics was awarded an AUD 1 million (approximately US $720,000) drug development research grant from FightMND, the largest independent funder of ALS research in Australia. The grant will support the translational development of M102, a drug candidate for the treatment of ALS. M102 showed promise to stop and reverse ALS disease progression, as evidenced by data in preclinical models. Currently, there is no cure for ALS and no effective treatments to halt or reverse the progression of this devastating disease.
Aclipse Therapeutics has successfully conducted the US FDA pre-IND meeting for M102. The FDA has reviewed the M102 preclinical data package and confirmed the necessary preclinical studies for M102 to initiate its first-in-human studies. The agency has also provided valuable guidance to support the clinical development of M102.