Details

Autor(en) / Beteiligte

• Oskarsson, Björn
• Maragakis, Nicholas
• Bedlack, Richard S
• Goyal, Namita
• Meyer, Jenny A
• Genge, Angela
• Bodkin, Cynthia
• Maiser, Samuel
• Staff, Nathan
• Zinman, Lorne
• Olney, Nicholas
• Turnbull, John
• Brooks, Benjamin Rix
• Klonowski, Emelia
• Makhay, Malath
• Yasui, Seiichi
• Matsuda, Kazuko

Titel

MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design

Ist Teil von

• Neurodegenerative disease management, 2021-12, Vol.11 (6), p.431-443

Ort / Verlag

England: Future Medicine Ltd

Erscheinungsjahr

2021

Link zum Volltext

Quelle

Taylor & Francis Journals Auto-Holdings Collection

Beschreibungen/Notizen

• Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with motor neuron loss as a defining feature. Despite significant effort, therapeutic breakthroughs have been modest. MN-166 (ibudilast) has demonstrated neuroprotective action by various mechanisms: inhibition of proinflammatory cytokines and macrophage migration inhibitory factor, phosphodiesterase inhibition, and attenuation of glial cell activation in models of ALS. Early-phase studies suggest that MN-166 may improve survival outcomes and slow disease progression in patients with ALS. This article describes the rationale and design of COMBAT-ALS, an ongoing randomized, double-blind, placebo-controlled, multicenter Phase IIb/III study in ALS. This study is designed to evaluate the pharmacokinetics, safety and tolerability and assess the efficacy of MN-166 on function, muscle strength, quality of life and survival in ALS. Amyotrophic lateral sclerosis (ALS) is a neurological disease defined by the loss of the nerve cells going to the muscles. Despite significant effort, we still do not have good treatments for ALS. MN-166 (ibudilast) can protect nerve cells by calming inflammation in several ways in models of ALS. Early human studies suggest that MN-166 may extend life and slow disease progression in ALS patients. This article describes the rationale and design of COMBAT-ALS, an ongoing randomized, double-blind, placebo-controlled, multicenter Phase IIb/III study. This study will show the drug’s safety and tolerability and its effects on physical function, muscle strength, quality of life and survival in people living with ALS. MN-166 (ibudilast) is a promising neuroprotective agent for the treatment of neurodegenerative disease. The clinical trial protocol in #fsgnmt provides a summary of the ongoing #COMBAT-ALS trial. Follow the link www.futuremedicine.com/doi/10.2217/NMT-2021-0042 to read full study details