HomeNewsibudilast, medicinova, ms, multiple sclerosisPh 2b trial results of MN-166 (ibudilast) in Progressive MS presented at AAN 2018

Ph 2b trial results of MN-166 (ibudilast) in Progressive MS presented at AAN 2018

  • April 26, 2018
  • Posted by: PharmaScroll
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MediciNova, Inc., a biopharmaceutical company, announced that Dr. Robert Fox, Staff Neurologist at the Cleveland Clinic and the principal investigator of this clinical trial, presented data from the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) at the American Academy of Neurology (AAN) 70th Annual Meeting held in Los Angeles, California during the Clinical Trials Plenary Session.

The highlights of the presentation entitled “A Phase II Trial of Ibudilast in Progressive Multiple Sclerosis” include the following:

  • For the primary endpoint of whole brain atrophy, MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo (p=0.04) in the modified ITT (intent-to-treat) population as measured by MRI analysis using brain parenchymal fraction (BPF), which was previously reported. New analysis of the primary endpoint of whole brain atrophy is confirmatory:
    • There was no evidence for outliers driving the overall result
    • A modified per-protocol sensitivity analysis was consistent with findings from the primary analysis (p=0.02)
    • Similarly, analysis to adjust for baseline age was consistent (p=0.03)
  • For the secondary endpoint of cortical atrophy (measured by Cortical Longitudinal Atrophy Detection Algorithm), MN-166 (ibudilast) demonstrated a statistically significant 80% reduction in the progression of cortical atrophy compared to placebo (p=0.004).
  • For the secondary endpoint of retinal nerve fiber layer thickness (measured by Optical Coherence Tomography), MN-166 (ibudilast) had no effect on the progression of retinal nerve fiber layer thinning.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, “We are extremely pleased with the new positive results from additional MRI analysis which confirms the positive effect of ibudilast in reducing the progression of whole brain atrophy.  We thank the NIH, the investigators, and the National Multiple Sclerosis Society and now we look forward to moving on to Phase 3.  As a next step, we are preparing for the end-of-Phase 2 meeting with FDA.  With a convenient oral administration, a very favorable 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.”

 

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News Source: MediciNova Website

Image Source: http://www.engineersjournal.ie/2015/04/07/medical-device-trials-design/