MediciNova has achieved the target enrolment of 200 patients in the SEANOBI-ALS clinical study, evaluating MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS).
The SEANOBI programme offers expanded access to MN-166 for people with ALS who do not qualify for ongoing randomised clinical trials.
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The study is funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), under the ACT for ALS initiative.
MediciNova stated that this enrolment milestone demonstrates engagement within the ALS community and reflects contributions from patients, families, investigators, and clinical staff.
Patients enrolled in SEANOBI-ALS are continuing treatment and follow protocol-mandated check-ups. The company has indicated that final follow-ups are expected to be completed in early 2027.
This will be followed by a data analysis phase led by an academic investigator to support scientific presentations and peer-reviewed publications.
MN-166 is described as an orally administered small molecule that inhibits phosphodiesterase 4 (PDE4) and inflammatory cytokines, such as macrophage migration inhibitory factor (MIF).
It is being investigated for a range of neuroinflammatory and neurodegenerative conditions, including ALS, degenerative cervical myelopathy, and glioblastoma.
The therapy is also being studied in Long Covid, progressive multiple sclerosis, chemotherapy-induced peripheral neuropathy, and substance use disorder.
MediciNova holds orphan drug designation (ODD) from both the US Food and Drug Administration (FDA) and European Medicines Agency for MN-166 in ALS, as well as fast track designation from the FDA for ALS. The compound also has ODD for glioblastoma.
MediciNova president and CEO Dr Yuichi Iwaki said: “Achieving full enrolment of 200 patients in this NIH funded SEANOBI-ALS study marks an extraordinary milestone for the ALS community. We are deeply grateful to the patients and families who have chosen to participate, as well as to the NIH for its vital support through the ACT for ALS.
“Their partnership has successfully enabled access to the investigational drug MN 166 (ibudilast) for individuals who otherwise lacked clinical trial options, and we remain entirely focused on executing the remaining protocol steps with the utmost urgency and care.”
MediciNova previously announced the full enrolment of its COMBAT-ALS Phase IIb/III clinical trial of MN-166 in September 2025.
