MediciNova to support NIH-funded EAP trial to evaluate MN166 in ALS

MediciNova announced that the National Institutes of Health – Neurological Disorders and Stroke has awarded $22 million for an intermediate size Expanded Access Protocol to evaluate the efficacy of MN-166 in Amyotrophic Lateral Sclerosis. In collaboration with an academic group, MediciNova will provide investigational drug MN-166, regulatory support, and safety monitoring support. The NIH grant is supported by the Accelerating Access to Critical Therapies for ALS Act signed into law by President Biden. Expanded Access, also referred to as Compassionate Use, is an FDA-regulated pathway that allows individuals with a serious and life-threatening disease to access an investigational drug that is not yet approved by the FDA. This EAP trial will allow individuals with ALS who are not eligible to participate in the COMBAT-ALS trial to receive treatment with MN-166. The EAP will evaluate neurofilament light, a biomarker for neuron damage, and clinical data in two hundred ALS patients treated with MN-166.