Ibudilast plus interferon-beta to get European patent for progressive MS

Protections for wide range of combo's doses and use run until October 2039

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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MediciNova announced the approval of a European patent covering the use of ibudilast (MN-166) in combination with interferon-beta medications to treat progressive forms of multiple sclerosis (MS) — primary progressive MS (PPMS) and secondary progressive MS (SPMS) — in patients previously using an interferon-beta.

The patent will apply to a wide range of doses, and dosing frequency and duration for both medications. It will also cover the use of the two therapies simultaneously or consecutively, and administered in the same or in separate dose forms. Patent protections would be valid at least until October 2039.

“We are very pleased to receive notice that this new patent will be granted in Europe and we believe it could increase the potential value of [ibudilast],” Kazuko Matsuda, MD, PhD, MediciNova’s chief medical officer, said in a company press release.

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Ibudilast designed to protect nerve cells damaged in multiple sclerosis

A similar U.S. patent covering this combination therapy and its use in treating progressive MS forms was granted previously.

In MS, the immune system mistakenly attacks the myelin sheath, a protective coating around nerve fibers that helps in sending electrical signals efficiently, causing the inflammation and damage that lead to a range of disease symptoms.

Ibudilast is an oral small molecule designed to lower the levels of pro-inflammatory signaling molecules that contribute to MS-driving inflammation and nerve cell damage.

A Phase 2b clinical trial, called SPRINT-MS (NCT01982942), analyzed the effects of ibudilast in 255 people with PPMS or SMPS, with or without relapses.

Participants were randomly assigned to either ibudilast or a placebo for 96 weeks (almost two years), and those being treated with glatiramer acetate (sold as Copaxone, generics available) or interferon-beta MS therapies could continue their use.

Interferon-beta therapies, such as Rebif, Avonex, Betaseron, Extavia, and Plegridy, contain a naturally occurring signaling molecule that immune cells use to reduce excessive inflammatory responses and better protect nerve cells.

SPRINT-MS demonstrated that ibudilast significantly slowed by 48% brain volume loss compared with a placebo, with a much stronger effect in PPMS patients. Its use also helped to protect nerve cells of the retina, a light sensitive layer of the eye whose thinning is associated with brain degeneration.

Ibudilast plus an interferon-beta show potential to slow disability progression

Moreover, “analysis of the data from our completed Phase 2b trial in progressive MS indicated that there may be a synergistic effect of the combination of [ibudilast] and interferon-beta which could result in an even lower risk of disability progression compared to the risk reduction for [ibudilast] alone,” Matsuda said.

MediciNova announced an intent to open a Phase 3 trial of ibudilast, potentially only in people with SPMS without relapses, in 2019.

Ibudilast also is being tested in Phase 2 and Phase 3 trials for other conditions, including amyotrophic lateral sclerosis.