Biopharmaceutical Company MediciNova has announced additional positive clinical data from its SPRINT-MS phase IIB trial of MN-166 (ibudilast) in progressive multiple sclerosis (PMS).
MN-166 has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS and substance abuse or addiction.
MN-166 demonstrated a 26% reduction in the risk of confirmed disability progression for people with MS compared to a placebo, which was measured by Expanded Disability Status Scale (EDSS). Confirmed disability progression was a secondary endpoint in this phase IIB trial, but will be considered as a main focus and primary endpoint in Phase III. Based on the strong trends in reducing confirmed disability progression in this Phase IIB trial, MediciNova’s power analysis has determined that a Phase III trial of MN-166 that enrols approximately 700 people will be sufficiently powered to achieve statistical significance for confirmed disability progression.
The data was presented by Dr Robert Naismith, Associate Professor of Neurology at Washington University School of Medicine and an investigator of the SPRINT-MS trial, on 01 February 2018 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in San Diego, California.
In October 2017, the trial reported achieving both of its primary endpoints. The first was that MN-166 demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo as measured by MRI analysis using brain parenchymal fraction (BPF).
The second primary endpoint was that MN-166 demonstrated a favourable safety and tolerability profile. There was not an increased rate of serious adverse events in the MN-166 group compared to the placebo group. There were no opportunistic infections, no cancers, no cardiovascular events (i.e. no heart attacks or strokes), and no deaths related to the treatment either. There was also no statistically significant difference in tolerability between the MN-166 group and the placebo group. The most common treatment-emergent adverse events during the study were gastrointestinal, which occurred with a higher frequency in the MN-166 group and upper respiratory tract infections, which occurred with a higher frequency in the placebo group.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova commented: 'We are extremely pleased with these results. Ibudilast’s magnitude of reduction in disability progression was better than the data reported for the only drug approved for progressive MS and also better than the data reported for the other drugs being developed for progressive MS. With a convenient oral administration, a very favourable safety and tolerability profile compared to other MS drugs and potentially better efficacy than any other drug for progressive MS, we believe ibudilast is well positioned to become the best-in-disease drug. As a next step, we plan to get formal feedback from FDA so we can move this program forward as fast as possible.'