ALS Treatment Enters Phase 2b/3 Clinical Study

A biopharmaceutical company announced that a kick-off meeting for a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS), was held on June 5, 2019. 

This is good news since there is not an ALS preventive vaccine available today, says the Centers for Disease Control and Prevention. 

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor, that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. 

It attenuates activated glial cells, which play a major role in certain neurological conditions. 

It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. 

This investigational therapy has been granted Fast Track Status by the U.S. Food and Drug Administration for the treatment of ALS. These designations are intended to expedite and support MN-166/ibudilast’s clinical development, review, and potential approval. 

Ibudilast’s benefits in ALS have been explored in a previous Phase 2 trial with 71 participants in combination with Rilutek. This study’s results showed that add-on treatment with ibudilast could significantly improve functional activity and quality of life in ALS patients compared with Rilutek alone. 

Ibudilast has been prescribed to over 3.2 million patients and has a good post-marketing safety profile. 

Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc., commented in a press release, "We are very pleased to achieve this milestone and look forward to initiating patient enrollment shortly.” 

Amyotrophic lateral sclerosis, 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. 

No one knows for sure what causes ALS and currently, there is no cure. The 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. 

MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.