MediciNova has posted midstage clinical data for ibudilast which suggest the drug is effective in progressive multiple sclerosis, a hard-to-treat form of the neurodegenerative disease.
The phase 2b SPRINT-MS trial showed that ibudilast was well-tolerated—as might be expected from a drug that has been on the market for more than two decades in Japan for asthma and poststroke complications—but also significantly slowed the progression of brain atrophy in progressive MS patients, says the biotech.
It’s another boost for the San Diego-based micro-cap’s lead drug program, after it reported preliminary data from an open-label study in April which suggested ibudilast was able to extend survival in patients with amyotrophic lateral sclerosis.
ALS is a small market, however, and success in MS could unlock a much bigger market for the drug, as would a third clinical program in drug dependence also in phase 2.
While 85% of the 2 million-plus people with MS worldwide have the relapsing-remitting form of the disease at the time of diagnosis, the remainder have a progressive form which results in steady declines in walking, vision and mental acuity. Added to that, most people with the relapsing form go on to develop progressive MS later on.
Robert Fox, M.D., of the Cleveland Clinic, lead investigator of SPRINT-MS, said in a release that the results with the drug are an “encouraging step forward” in progressive MS which—until a green light for Roche’s Ocrevus (ocrelizumab) infusion in March—had no FDA-approved therapies.
Ocrevus’ first-to-market position in both relapsing-remitting and primary progressive MS has put it on course for sales north of $4 billion by 2022, according to EvaluatePharma, but MediciNova is hoping that there will be an opportunity to grab a slice of the market for its orally active small-molecule drug. It reckons the market for progressive MS therapies could in time rival that of relapsing-remitting MS therapies, which topped $20 billion worldwide last year.
The biotech will put the results of the study in front of neurologists at the joint ECTRIMS-ACTRIMS conference in Paris later this week and for now isn’t giving away too much detail other than to say ibudilast achieved a significant reduction in the progression of brain atrophy compared to placebo, using MRI analysis of the volume of the brain parenchymal fraction as a biomarker.
The phase 2b trial enrolled 255 patients who were treated with a twice-daily dose of ibudilast up to 100 mg/day or placebo. Some of the patients enrolled in the trial were on no other treatment, but a proportion continued to receive interferon beta or glatiramer acetate. Secondary outcome measures include the progression of disability, cognitive impairment and quality-of-life scores.