Recently, MediciNova, a “biopharmaceutical company that develops therapeutics with a focus on neurology, respiratory and liver diseases with unmet needs”, as stated on their website, has posted mid-stage clinical data for ibuildilast.
This suggests that the drug is effective in progressive multiple sclerosis, a neurodegenerative disease that is very difficult to treat.
The trial (phase 2b SPRINT-MS) displayed that ibuildilast was actually well-tolerated by the subject, and it significantly slowed down the progression of brain atrophy—a symptom of MS—in patients, says the biotech.
This drug has been on the market for more than twenty years in Japan for asthma and postsroke complications.
The market of ALS is a small one, but success in combating Multiple Sclerosis could potentially unlock a greater market for the drug. Also, a third clinical program in drug dependence could arise as well, as this program is now currently in phase 2.
Approximately 85% of more than 2 million people worldwide with MS have the relapsing-remitting form of the disease at the time of the diagnosis, and the remainder have a more progressive form which results in the decline of motor actions such as walking, and vision and mental acuity as well. Unfortunately, most of those who have the relapsing form of MS go on to develop the progressive one as time goes by.
Lead investigator of SPRINT-MS, Robert Fox, M.D., recently said in a release that the results with the drug are an “encouraging step forward” in the progressive form of MS—which had no FDA-approved therapies, until it was given a green light for Roche’s injectable antibody, Ocrevus (ocrelizumab) in March.
Ocrevus had a first-to-market position in both relapsing-remitting and primary progressive MS, which put it on a course for sales of more than $4 billion by 2020, according to EvaluatePharma. However, MediciNova is hoping that there will be some opportunity to be able to get a part of the market for its orally-active, small-molecule drug.
It believes that the market for progressive MS therapies could, in time, rival that of relapsing-remitting MS therapies, which topped $20 billion globally last year.
The results of the study will be published in front of neurologists at the ECTRIMS-ACTRIMS, a conference in Paris, later this week.
For now, the biotech company is not giving away too many details other than stating that ibuildilast has achieved a very significant reduction in the progression of brain atrophy compared to the placebo variable, using MRI analysis of brain parenchymal fraction volume as a biomarker.
Currently, the phase 2b trial has enrolled 255 patients who were all treated with either a bi-daily dose of ibuildilast up to 100 mg/day or the placebo. Some patients on the trial were not given any other treatment, but another portion continued to be administered interferon beta or glatiramer acetate.
The secondary outcome measures include the continuation and progression of cognitive impairment, disability, and life quality scores.