ALS Patients Show Gains in Ongoing Study of MediciNova’s Ibudilast Therapy

ALS Patients Show Gains in Ongoing Study of MediciNova’s Ibudilast Therapy

MediciNova has presented positive interim data from an ongoing clinical trial to evaluate the efficacy and safety of MN-166 (ibudilast) in the treatment of amyotrophic lateral sclerosis (ALS). The study, entitled “Adaptive Design Single Center Phosphodiesterase Type 4 (PDE4) Inhibitor – Ibudilast (MN-166) Phase 1b/2a Clinical Trial [NCT02238626] for Amyotrophic Lateral Sclerosis (ALS) Patients [1] Not Requiring Non-Invasive Ventilation (no-NIV) up to 5 years and [2] Requiring Non-Invasive Ventilation (NIV) up to 10 years from Disease Onset,” was presented by principal investigator Dr. Benjamin Rix Brooks at the 26th International Symposium on ALS/MND (amyotrophic lateral sclerosis/motor neurone disease).

The clinical trial (ClinicalTrials.gov Identifier: NCT02238626), which is recruiting patients, is a randomized and placebo-control study to evaluate the efficacy and safety of MN-166 (ibudilast) in the treatment of early and advanced stage ALS patients. MN-166, licensed by MediciNova from Kyorin Pharmaceutical for potential utility in relapse-remitting multiple sclerosis (RRMS), is a small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF), whose anti-neuroinflammatory and neuroprotective properties have been proven in previous preclinical and clinical trials. The trial aims to enroll 60 ALS patients without NIV (Non-Invasive Ventilator) and an additional 60 ALS patients with NIV.

The presentation, referring to results from a total of 36 subjects, covered several efficacy points addressed by the trial, such as functional activity (ALSFRS-R), respiratory function, and muscle strength. The first results included the ALSFRS-R score from baseline to month six, a measure of functional impairment, which was below rates observed in other ALS trials. Moreover, non-invasive ventilation (NIV) usage was lower in clinical trial participants when compared to a sample from ALS Multidisciplinary Clinic patients. In the non-NIV group, slow vital capacity (SVC), a measure of respiratory function, declined by 1.50% predicted/month, a value also below rates previously observed. No significant adverse effects differences were found between the drug and placebo groups. The subjects will now proceed to the six-month, open-label extension part of the study.

Dr Yuichi Iwaki, MD, president and chief executive officer of MediciNova, said in a press release, “We are very pleased with the encouraging interim data, particularly the slow vital capacity and NIV utilization data which may indicate that MN-166 has potential to improve respiratory function in ALS patients. If the final results of the study confirm it, MN-166 would potentially offer a substantial clinical benefit in the treatment of ALS as most patients die from respiratory failure.”

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