Results for Ibudilast Phase II trial in progressive MS to be presented at AAN

MediciNova would be presenting Phase II trial results for Ibudilast, an oral therapy which works by suppressing three cytokines that promote inflammation: IL-1ß, TNF-a, and IL-6 and is considered to have potential to effectively treat progressive multiple sclerosis (MS).

The trial was conducted with an aim to assess efficacy, safety, and tolerability of ibudilast in progressive MS. 255 subjects with primary or secondary progressive MS and evidence for disability progression in the prior two years were randomized to receive either ibudilast up to 100 mg/d or matching placebo. Over this 96 week study, clinical and imaging outcomes were assessed every 24 weeks. Primary outcome was change in brain atrophy as measured by brain parenchymal fraction (BPF) over 96 weeks. Secondary outcomes included magnetization transfer ratio (MTR), diffusion tensor imaging (DTI), optical coherence tomography and cortical atrophy. Analysis was based on modified intention-to-treat (mITT). Linear mixed effects modeling was used to estimate the rate of change of each imaging measure; the difference in rates between groups was used to assess efficacy.

Results of the study:

244 subjects (96%) were included in the mITT analysis; 220 (86%) completed 96 weeks follow-up. Ibudilast was associated with a 48% reduction in the rate of brain atrophy progression (p=0.04). The adverse events reported more commonly (p<0.1) with ibudilast included gastrointestinal (nausea, diarrhea, abdominal pain, and vomiting), rash, depression, and fatigue. There was no significant difference in either serious adverse events or discontinuation rates between the groups. Ibudilast was associated with a 77–82% reduction in change in MTR (p=0.05), and a trend for improvement on transverse diffusivity (p=0.15). Remaining secondary and clinical outcomes will be presented.

The study concluded that budilast met its primary outcome of brain atrophy. Safety and tolerability were also favorable. The study highlighted that the results support further investigation of ibudilast as a potential treatment for progressive MS.

About Pharmascroll:

Pharmascroll is a diligent business consulting and market research firm focused solely towards pharmaceutical markets. The company consults and researches in majorly chronic disease indications prevalent across the globe. The research conducted by Pharmascroll analysts is targeted to provide analytical and logical answers to the key business questions of the pharmaceutical and medical insights teams and to make better informed business decisions with the detailed relevant information available.

To read more news about Multiple Sclerosis, visit https://pharmascroll.com/news-category/multiple-sclerosis/

News Source: http://n.neurology.org/content/90/15_Supplement/CT.004

Image Source: http://local12.com/health/medical-edge-reports/medication-shows-promise-treating-progressive-ms