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news.The US Food and Drug Administration (FDA) has approved the protocol of a new clinical trial in ALS patients, “A Single-Center, Open-Label Biomarker Study to Evaluate MN-166 (ibudilast) in Subjects with Amyotrophic Lateral Sclerosis (ALS).”
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This study is a collaborative effort between MediciNova and Drs. Nazem Atassi and Haruhiko Banno, Principal Investigators at Massachusetts General Hospital’s (MGH) Neurological Clinical Research Institute (NCRI) and Harvard Medical School to measure the effects of MN-166 on reducing brain microglial activation utilizing a biomarker in 15 subjects with ALS. This trial is expected to commence shortly.
MediciNova president and CEO Yuichi Iwaki said: "We are very pleased that this important regulatory step is now completed as we can continue clinical evaluation of MN-166 in the treatment of ALS.
"The objective of this trial is to evaluate MN-166 by measuring its effects using a novel imaging technology that will complement the conventional assays typically utilized in ALS trials."
About the ALS Biomarker Trial
This is an Open-Label, Proof-of-Mechanism, Phase 2a trial of ibudilast in ALS patients. Approximately 15 ALS subjects will be recruited and will be treated with ibudilast 50 mg twice daily for 36 weeks. The primary objective of this trial is to measure the effects of ibudilast on reducing brain microglial activation measured by [11C]-PBR28-PET (biomarker) in subjects with ALS. Secondary objectives include evaluation of the safety, tolerability, and clinical outcomes (ALS functional rating scale [ALSFRS-R], slow vital capacity [SVC], and muscle strength [measured by HHD – hand-held dynamometry) over 36 weeks.
About ALS
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 totally paralyzed.
Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 30,000 ALS patients in the U.S. and approximately 5,600 people in the U.S. are diagnosed with ALS each year. Riluzole is the only pharmaceutical treatment approved for ALS, but it has limited efficacy.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical for potential utility in relapse-remitting multiple sclerosis (RRMS). Intellectual property was additionally established or obtained by MediciNova in progressive MS and other neurological conditions. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) 4 and 10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors.
It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its potential therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain.