TY - JOUR
T1 - MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study
T2 - COMBAT-ALS study design
AU - Oskarsson, Björn
AU - Maragakis, Nicholas
AU - Bedlack, Richard S.
AU - Goyal, Namita
AU - Meyer, Jenny A.
AU - Genge, Angela
AU - Bodkin, Cynthia
AU - Maiser, Samuel
AU - Staff, Nathan
AU - Zinman, Lorne
AU - Olney, Nicholas
AU - Turnbull, John
AU - Brooks, Benjamin Rix
AU - Klonowski, Emelia
AU - Makhay, Malath
AU - Yasui, Seiichi
AU - Matsuda, Kazuko
N1 - Publisher Copyright:
© 2021 MediciNova, Inc.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - ALS
KW - amyotrophic lateral sclerosis
KW - glial cell attenuation
KW - ibudilast
KW - neurodegenerative disease
KW - neuroprotection
KW - survival
UR - http://www.scopus.com/inward/record.url?scp=85121913252&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121913252&partnerID=8YFLogxK
U2 - 10.2217/nmt-2021-0042
DO - 10.2217/nmt-2021-0042
M3 - Article
C2 - 34816762
AN - SCOPUS:85121913252
SN - 1758-2024
VL - 11
SP - 431
EP - 443
JO - Neurodegenerative disease management
JF - Neurodegenerative disease management
IS - 6
ER -