MediciNova’s Experimental ALS Therapy Found to be Safe in Clinical Trial

Biopharmaceutical company MediciNova, Inc. recently announced in a press release that the initial results of an ongoing clinical trial for the drug MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) were presented by the study’s principal investigator Dr. Benjamin Rix Brooks at the 2015 American Academy of Neurology (AAN) 67th Annual Meeting held in Washington, DC.

ALS is a progressive neurodegenerative disease, characterized by the gradual degeneration and atrophy of motor neurons in the brain and spinal cord that are responsible for controlling voluntary muscles, such as the ones related to movement, speaking, eating, and even breathing. ALS patients may become totally paralyzed and the majority of patients succumb to the disease due to respiratory failure within two to five years post diagnosis. The ALS Association estimates that approximately 5,600 individuals in the United States are diagnosed with the disease every year. Currently, the only drug treatment approved for ALS is riluzole, although it has limited efficacy.

MN-166 (ibudilast), which is used in Korea and Japan for bronchial asthma and post-stroke complications, has been licensed by MediciNova for its potential use in relapse-remitting multiple sclerosis (RRMS), also a progressive neurodegenerative disorder that leads to impairment in motor function and irreversible neurological disability. MN-166 (ibudilast) is an orally bioavailable small molecule that has anti-neuroinflammatory and neuroprotective properties and has therefore potential therapeutic effects in neurodegenerative diseases like ALS.

The ongoing clinical trial corresponds to a randomized, placebo-controlled, double-blind study that includes a treatment period of six months followed by a six months open-label extension. The goal of the trial was to evaluate the safety and efficacy of MN-166 (ibudilast; 60 mg/day) in ALS patients in terms of muscle strength, respiratory function, functional activity and non-invasive ventilation (NIV) utilization. MN-166 (ibudilast) was provided in combination with riluzole.

Researchers conducted an interim safety review concerning the first 21 patients enrolled in this trial and found no reported safety or tolerability issues regarding MN-166 (ibudilast) after three months of treatment. No clinically significant electrocardiogram irregularities were reported in either patients under MN-166 (ibudilast) treatment or in the placebo group. These results supported the continuation of the clinical trial according to the initial plan.

“We are very pleased with the findings from the interim safety analysis, as we may now continue with the trial as planned. We look forward to completing enrollment and providing further updates as the study progresses,” concluded the President and Chief Executive Officer of MediciNova, Inc., Dr. Yuichi Iwaki.