MediciNova has completed full patient enrolment in the COMBAT-ALS Phase IIb/III clinical trial of MN-166 (ibudilast) as a potential therapy for amyotrophic lateral sclerosis (ALS).
The trial randomised 234 participants across two treatment arms at several clinical centres in Canada and the US. Recruitment is now closed.
MN-166 is a small molecule orally administered, intended to modulate neuroinflammation and oxidative stress implicated in ALS progression.
COMBAT-ALS is a double-blind, randomised, placebo-controlled study with a 12-month blinded phase followed by a six-month open-label extension.
The primary efficacy endpoint is the Combined Assessment of Function and Survival (CAFS). Secondary endpoints include the ALS Functional Rating Scale Revised (ALSFRS-R), quality of life evaluations, and muscle strength as measured by hand-held dynamometry. Top-line results are anticipated by the end of next year.
Previous studies of MN-166 showed a positive safety profile and indications of treatment response in preclinical models and Phase I/II and Phase II studies.
The therapy holds fast track and orphan drug designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency.
MediciNova chief medical officer Dr Kazuko Matsuda said: “Completing enrolment in this Phase IIb/III trial marks a major milestone for our MN-166 programme and reflects the dedication of our clinical team and the ALS community.
“We are deeply grateful to the patients and families participating in this study and look forward to advancing MN-166 (ibudilast) toward potential regulatory submission.”
MediciNova president and CEO Dr Yuichi Iwaki said: “ALS remains a devastating disease with limited treatment options. We are hopeful that MN-166 may offer a meaningful therapeutic advance for patients living with ALS.”
