MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the ongoing biomarker clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis) is now fully enrolled with 35 subjects. This trial will measure the effect of MN-166 (ibudilast) on reducing brain microglial activation measured by positron emission tomography (PET) imaging using a biomarker and will also evaluate clinical outcomes in ALS subjects. The principal investigator is Dr. Nazem Atassi at Massachusetts General Hospital’s Neurological Clinical Research Institute and Harvard Medical School.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that this study is now fully enrolled. We look forward to providing further updates as we expect to receive data from this study next year.”
About the ALS Biomarker Trial
This is an ongoing, open-label, Phase 2a trial of MN-166 (ibudilast) in 35 ALS subjects. Subjects are being treated with MN-166 (ibudilast) 50 mg twice daily for 36 weeks. The primary objectives of this trial are (1) to measure the effect of MN-166 (ibudilast) on reducing brain microglial activation measured by [11C]-PBR28-PET (biomarker) uptake in the motor cortices and brain stem, and (2) to measure the effect of MN-166 (ibudilast) on several markers of neuro-inflammation measured by blood biomarkers. In addition to safety and tolerability, secondary objectives include evaluation of clinical outcomes including ALSFRS-R (ALS functional rating scale), SVC (slow vital capacity), and muscle strength measured by HHD (hand-held dynamometry).
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 20,000 ALS patients in the U.S. and approximately 6,000 people in the U.S. are diagnosed with ALS each year.