Ibudilast, Potential Progressive MS Therapy, Awaits US Patent

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by Patricia Inacio PhD |

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MediciNova announced that it will be given a U.S. patent covering the use of ibudilast (MN-166) in treating eye disease. This oral medication aims to lessen inflammation, including that of progressive multiple sclerosis (MS).

Specifically, it will cover ibudilast’s use in  treating injury or damage to the macula — the part of the retina at the back of the eye — due to neuro-ophthalmologic or neurodegenerative diseases, such as MS. Once issued, the patent will be valid at least until October 2039.

“We are very pleased to receive notice that this new patent will be granted because it could substantially increase the potential value of MN-166 as it provides more options for further development and commercialization,” Kazuko Matsuda, MD, PhD, chief medical officer of MediciNova, said in a press release.

The thinning of certain of the eye’s retinal layers has been proposed as a potential biomarker of brain volume loss and overall disease activity in people with MS.

These layers’ thickness can be measured using optical coherence tomography (OCT), an imaging technique that relies on light waves to non-invasively acquire cross-sectional pictures of the retina.

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Results of a Phase 2 progressive MS clinical trial — called SPRINT-MS (NCT01982942) — showed that ibudilast significantly slowed brain volume loss (by 48%), and increased the thickness of a particular retinal layer called peripapillary retinal nerve fiber layer (pRNFL) in treated patients.

It enrolled 255 people with either primary or secondary progressive MS, who were randomized to either ibudilast or a placebo for 96 weeks (about 22 months).

Patients on ibudilast also experienced a slower decrease in the thickness of another retinal layer, called the ganglion cell inner plexiform layer, and a slower loss of macular volume compared with those on a placebo.

These findings were independent of the kind of device used to acquire the OCTs, and suggested that ibudilast may help prevent further damage to the macula.

“Last November, we reported positive optical coherence tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. All OCT measures showed less loss of retinal tissue for MN-166 compared to placebo,” Matsuda said.

Ibudilast is a small molecule thought to ease the neuroinflammation underlying MS symptoms by blocking the activity of phosphodiesterase type-4 (PDE-4) and other pro-inflammatory proteins, namely IL-1 beta, TNF-alpha, and IL-6.

The investigational therapy is also being tested for other neurodegenerative diseases, including amyotrophic lateral sclerosis, glioblastoma, and chemotherapy-induced peripheral neuropathy, a condition characterized by damage to peripheral nerves.

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