MediciNova to Present ALS Treatment Data from Ongoing Ibudilast Clinical Trial

Margarida Azevedo, MSc avatar

by Margarida Azevedo, MSc |

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ALS treatment clinical trial

MediciNova Inc. announced it will present data from its ongoing clinical trial evaluating MN-166 (ibudilast) in both early and advanced stage amyotrophic lateral sclerosis (ALS) patients at the 68th Annual Meeting of the American Academy of Neurology (AAN) April 15-21 at the Vancouver Convention Centre in Vancouver, Canada.

The ongoing randomized, double-blind, placebo-controlled clinical trial is assessing MN-166 efficacy endpoints such as functional activity (ALSFRS-R), respiratory function, and muscle strength in ALS patients. The trial includes six months of treatment period followed by six months of open-label extension and aims to enroll 60 patients with ALS without NIV (non-invasive ventilator) and an additional 60 ALS patients with NIV.

The ongoing clinical trial is a collaboration between MediciNova and Benjamin Rix Brooks, director of the Carolinas HealthCare System Neuroscience Institute Neuromuscular/ALS-MDA Center.

The study, “Adaptive Design Single Center Phosphodiesterase Type 4 (PDE4) Inhibitor – Ibudilast (MN-166-ALS-1201) Phase 1b/2a Clinical Trial Double-Blind (DB) with Open Label Extensions (OLE) [ NCT02238626 ] for Amyotrophic Lateral Sclerosis (ALS) Patients [1] Not Requiring Non-Invasive Ventilation (no-NIV) up to 5 years (Early Cohort – EC) and [2] Requiring Non-Invasive Ventilation (NIV) up to 10 years (Advanced NIV Cohort – ANC) from Disease Onset – Behavior of Creatinine as a Biomarker in Short Clinical Trials,” will be presented at two different times as a lecture and as an individual discussion. The abstract will be available for review on April 20.

MN-166 (ibudilast) is an orally bioavailable small molecule with anti-neuroinflammatory and neuroprotective properties, and holds potential therapeutic effects in neurodegenerative diseases like ALS.

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The ALS Association has announced its new Translational Research Advancing Therapy for ALS (TREAT ALS) Drug Development Contract grant program, which will fund research for the development of new treatments for amyotrophic lateral sclerosis (ALS).

According to a press release, the program will support research from early target identification to preclinical studies and early pilot clinical trials. Successful grants with the best and most advanced development plan will receive up to $500,000 in investment funds for a maximum of two years.