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

Area of Science:

• Neuroscience
• Neurology
• Pharmacology

Background:

• Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by motor neuron loss.
• Current therapeutic options for ALS offer modest benefits, highlighting the need for novel treatments.
• Ibudilast (MN-166) exhibits neuroprotective properties through mechanisms including anti-inflammatory effects and glial cell modulation.

Purpose of the Study:

• To evaluate the safety, tolerability, and efficacy of MN-166 in patients with ALS.
• To assess the impact of MN-166 on functional outcomes, muscle strength, quality of life, and survival in ALS.
• To characterize the pharmacokinetics of MN-166 in the ALS patient population.

Main Methods:

• The COMBAT-ALS study is a randomized, double-blind, placebo-controlled, multicenter Phase IIb/III clinical trial.
• Participants with ALS will be randomized to receive either MN-166 or a placebo.
• The study will monitor pharmacokinetic parameters, safety, tolerability, and efficacy endpoints over the study period.

Main Results:

• This section will be populated once the study is completed and results are available.

Conclusions:

• This section will be populated once the study is completed and conclusions can be drawn.