MediciNova has enrolled the first patient in a National Institutes of Health (NIH)-funded Expanded Access Program (EAP) to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS). This trial will include approximately 200 ALS patients ineligible for the ongoing Phase 2/3 COMBAT-ALS trial and will assess MN-166’s safety and efficacy. The NIH’s support, specifically from the Neurological Disorders and Stroke (NINDS) branch, is facilitated through the Act for ALS.
This EAP signifies a crucial step in ALS research, offering a potential treatment avenue for patients previously excluded from clinical trials due to their advanced disease stage. Access to MN-166 under the EAP offers a glimmer of hope for these individuals and their families, potentially slowing disease progression or alleviating symptoms. The data collected from this larger patient population will significantly contribute to a more comprehensive understanding of MN-166’s efficacy and safety profile in diverse ALS cases.
MN-166, an orally administered small molecule compound, inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). MediciNova currently has 11 programs in clinical development based on MN-166 and another compound, MN-001 (tipelukast). MN-166 is already in Phase 3 trials for ALS and degenerative cervical myelopathy (DCM), and is Phase 3-ready for progressive multiple sclerosis (MS). Phase 2 trials are also underway evaluating MN-166 for Long COVID and substance dependence.
The initiation of this NIH-funded EAP is a significant development for MediciNova, reinforcing the potential of MN-166 as a viable ALS treatment. Positive results from the EAP could expedite the drug’s development and regulatory approval process, potentially bringing a much-needed therapy to a broader ALS patient population sooner. The trial data will not only inform the future of MN-166 in ALS but also contribute valuable knowledge to the broader understanding and management of this devastating disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
