MN-166 (Ibudilast) Granted “Fast Track” Designation by FDA to Speed its Potential Approval for Progressive MS
March 22, 2016
MediciNova, Inc. has announced that the experimental oral therapy MN-166 (ibudilast) has been designated by the U.S. Food and Drug Administration as a “Fast Track Product” in terms of its development as a possible treatment of progressive MS, including secondary progressive
and primary progressive
MS. Fast Track is a process designed to facilitate the development, and expedite the review of, treatments for serious conditions and fill an unmet medical need (read more on the FDA Web site)
. Fast Track would apply once the company submits the data from phase III trials to the FDA, along with a New Drug Application.
Investigators are currently conducting a phase II clinical trial
of ibudilast in 250 people with progressive forms of MS, at 28 sites nationwide. The study, called the SPRINT-MS trial, is principally funded by the National Institutes of Neurological Diseases and Stroke (NINDS), with additional support by MediciNova and the National MS Society. This trial is ongoing with all participants enrolled, and is expected to report results in 2017.
“This is good news for people with progressive forms of MS, for which there are few treatment options,” says Bruce Bebo, PhD, Executive Vice President, Research at the National MS Society. “We look forward to the completion of this groundbreaking clinical trial and the FDA’s Fast Track review of the results.”
Among other actions, ibudilast inhibits an enzyme called phosphodiesterase, and has been shown to protect brain tissue in animal models. While considered a “New Chemical Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat asthma and symptoms from cerebrovascular disorders. In a previous study, ibudilast did not reduce relapses or MRI-observed new lesions in a phase II trial involving people with relapsing MS. However, some evidence that this agent could protect the nervous system from damage (neuroprotection) was observed, which is why it’s being tested further in people with progressive forms of MS. (Neurology 2010;74:1033
Read about more agents under study for progressive MS (pdf).
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.