Canada Approves New Patent Covering Ibudilast’s Use for ALS Treatment

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by Alice Melão |

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The Canadian Intellectual Property Office has approved a new patent application that will allow MediciNova to use its investigational therapy ibudilast (MN-166) for the treatment of patients with amyotrophic lateral sclerosis (ALS) in Canada.

The patent covers a wide range of oral ibudilast doses in people diagnosed with ALS, granting MediciNova exclusive rights to ibudilast as treatment for this neurodegenerative disease in Canada. Once issued, the patent is expected to expire no earlier than July 2028.

“We are very pleased to receive notice that this new patent will be granted as we believe it could substantially increase the potential value of MN-166,” Yuichi Iwaki, MD, PhD, president and CEO of MediciNova, said in a press release.

Ibudilast is an oral, small molecule inhibitor that targets the PDE4 and PDE10 enzymes and the MIF protein. Its broad targeting is thought to reduce the activity of immune cells in the brain and increase the production of neurotrophic factors that support the survival and growth of nerve cells that control movement.

The investigational therapy has been granted fast track status and orphan drug designation by the U.S. Food and Drug Administration, as well as orphan medicinal product designation by the European Commission for the treatment of ALS. The designations are intended to expedite and support ibudilast’s clinical development, review, and potential approval.

In a prior Phase 2 trial (NCT02238626), researchers investigated the safety and effectiveness of ibudilast, as an add-on to Rilutek (riluzole), in adult patients with ALS.

Results showed that ibudilast significantly improved patients’ functional activity, quality of life, and muscle strength, compared to a placebo. The ibudilast-Rilutek combo also delayed disease worsening and improved survival rates.

Complete results from the Phase 2 trial will be presented at the upcoming 30th International Symposium on ALS/MND, taking place in Dec. 4–6, in Perth, Australia. The presentation, “Interaction (nonuniformity) of ALS Progression and the Efficacy of MN166 (ibudilast),” will be given by Kazuko Matsuda, MD, PhD, MPH, chief medical officer of MediciNova.

“We are very pleased to present additional findings from the completed ALS study,” Iwaki said in another press release. “We will take this opportunity to share with ALS/MND researchers, clinicians, and patients the results and conclusions of the study that laid the foundation for the design and implementation of our upcoming pivotal ALS trial.”

The recently launched, pivotal Phase 2b/3 trial (NCT04057898) is expected to enroll approximately 150 participants across several sites in the U.S.

Eligible patients must have the disease for no more than 18 months and just mild disability, determined by a score of at least 35 on the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) at screening.

Researchers will evaluate the ability of ibudilast to prevent ALS progression and patients’ functional disability compared with placebo by determining changes in the ALSFRS-R score at the end of the treatment period.

Pending the success of the trial, the collected data is expected to support ibudilast’s approval for treating ALS.