Data Readout

MediciNova heads toward H2-2026 ALSFRS-R data for ibudilast in ALS

The COMBAT-ALS trial is the only Phase 2/3 PDE4-inhibitor program running in ALS, leaving a functional-decline and survival readout with no direct in-class comparator.

By AppliedXLJuly 14, 2026Trial NCT04057898

Executive Summary

MediciNova has told shareholders to expect topline data this year from its long-running Phase 2/3 trial testing ibudilast in ALS, a readout that will measure functional decline and survival rather than a surrogate marker.
No other industry-sponsored trial has advanced a PDE4 inhibitor into Phase 2 or later testing in ALS, so the result will be read as a first test of this mechanism in this disease rather than against a direct rival's data.
The sponsor's own guided data window runs through the end of 2026, but the trial's registered primary completion date was pushed out to April 2027 in the most recent amendment, a divergence that has not been reconciled.
Enrollment closed above its original target and the trial moved cleanly into its post-enrollment phase, signaling normal execution rather than a program in distress.

The catalyst

MediciNova, Inc. told shareholders on June 30, 2026 that it expects topline data from its COMBAT-ALS trial before the end of the year. The trial, registered as NCT04057898, is evaluating MN-166 (ibudilast) over 12 months followed by a 6-month open-label extension in patients with amyotrophic lateral sclerosis. Its primary outcome measure is the change from baseline in ALSFRS-R score, a validated ALS functional-decline scale, at Month 12 or last measurement before death in the case of censoring, combined with survival time. MediciNova+1

Trial status and timing

The trial is Active, not recruiting, having enrolled 234 patients, above its original 230-patient count, when it stopped recruiting in September 2025. Its registered primary completion date has moved three times since 2024: from December 2023 to December 2024, then to December 2025, then in March 2026 to April 2027. That April 2027 registered date falls outside the sponsor's H2-2026 topline guidance issued the same week the letter went out, a divergence between the registry timeline and the disclosed communication timeline that has not been reconciled. NCT04057898+1

What the design can establish

The trial is registrational, industry-sponsored, and designed as a randomized, controlled Phase 2/3 study, giving its ALSFRS-R and survival endpoints decision-grade weight if the analysis population matches the enrolled cohort. No results have posted to ClinicalTrials.gov as of this writing. The company's own regulatory history shows ibudilast holds Orphan Drug and Fast Track designations from the FDA, along with Orphan Designation from the European Commission, signals of unmet need in ALS rather than a marker of approval likelihood. NCT04057898

A mechanism without a direct peer

No other industry-sponsored trial has advanced a phosphodiesterase-4 inhibitor into Phase 2 or later testing in ALS, making COMBAT-ALS the only asset at this class-indication intersection. The nearest ALS-focused Phase 2/3 programs test different mechanisms entirely: masitinib against KIT, pridopidine against the sigma-1 receptor, and an NLRP3 inflammasome inhibitor, none of which shares ibudilast's PDE4 target. With no validated disease-modifying mechanism established in this competitive field, a result that shows a slowing of ALSFRS-R decline paired with a survival signal that holds up in the open-label extension would be the finding that distinguishes this readout from a mechanism the field has not yet validated.

Sponsor track record

MediciNova has completed 14 of 15 prior trials tracked across its portfolio, with one termination, and has completed both of its prior Motor Neuron Disease trials. That execution history supports the trial reaching a readable dataset, though it does not speak to what that dataset will show. MediciNova

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