Results on Ibudilast Clinical Trial To Be Presented At 2015 International Symposium on ALS/MND

Patrícia Silva, PhD avatar

by Patrícia Silva, PhD |

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MediciNova, Inc., a biopharmaceutical company established in San Diego, recently announced in a press release that an abstract centered on the ongoing clinical trial evaluating the company’s product MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS) has been accepted for a presentation at the 26th International Symposium on ALS/MND (motor neurone disease) that will take place in Orlando from 11 to 13 December, 2015.

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 dies due to respiratory failure within two to five years after diagnosis. The ALS Association estimates that there are 30,000 American ALS patients, and that approximately 5,600 individuals are diagnosed with the disease every year in the United States. Currently, there is no cure for ALS, so effective therapeutic agents are urgently needed.

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 application 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, having therefore potential therapeutic effects in neurodegenerative diseases like ALS. Due to its properties, MN-166 is also being considered as a therapy for substance abuse/addiction and chronic neuropathic pain.

The MediciNova’s ongoing clinical trial (trial register NCT02238626) corresponds to a single center, 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 is to evaluate the safety and efficacy of MN-166 (60 mg/day) in ALS patients in terms of muscle strength, functional activity and respiratory function.

Data on safety and clinical outcomes of MN-166 treatment will be presented at the ALS/MND symposium on December 13 (8:50 AM), 2015 by Dr. Benjamin Rix Brooks, the study’s principal investigator and Director of the Carolinas HealthCare System’s Neuromuscular/ALS MDA Center where the trial is being conducted.

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