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MediciNova Announces Interim Data from Clinical Trial of MN-166 (ibudilast) in ALS Presented at the American Academy of Neurology (AAN) 68th Annual Meeting in Vancouver, Canada

LA JOLLA, Calif., Apr 20, 2016 (GLOBE NEWSWIRE via COMTEX) --

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market MNOV, -1.49% and the JASDAQ Market of the Tokyo Stock Exchange (code number:4875), announced that principal investigator Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System's Neuromuscular/ALS-MDA Center, will present interim data today from MediciNova's ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology (AAN) 68th Annual Meeting at the Vancouver Convention Centre in Vancouver, BC, Canada. The interim analysis, which was performed by an independent statistician consultant, includes a total of 25 subjects without non-invasive ventilator support who completed the 6-month double-blind treatment period with complete spirometry (respiratory function test) data.

Major findings from the interim analysis include the following:

  • The mean decline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score (the higher the score the more function is retained) from Baseline to Month 6 was 4.55 (0.76 per month) in the MN-166 group compared to 5.80 (0.97 per month) in the placebo group (a higher rate of decline indicates a greater worsening of disability).
  • The lower decline in the ALSFRS-R total score in the MN-166 group was driven by lower declines in two ALSFRS-R subscores: the ALSFRS-R Bulbar score and the ALSFRS-R Arm score.
  • The mean decline in the ALSFRS-R Bulbar score (which measures speech, salivation and swallowing ability) from Baseline to Month 6 was 0.90 (0.15 per month) in the MN-166 group compared to 1.80 (0.30 per month) in the placebo group.
  • The mean decline in the ALSFRS-R Arm score (which measures handwriting, cutting foods/handling utensils, and dressing/hygiene ability) from Baseline to Month 6 was 1.50 (0.25 per month) in the MN-166 group compared to 2.40 (0.40 per month) in the placebo group.
  • The mean decline in slow vital capacity (SVC), a measure of respiratory function, from Baseline to Month 6 was 10.93% (1.82% per month) in the MN-166 group compared to 12.71% (2.12% per month) in the placebo group.
  • As this is the first study of MN-166 in ALS, there was no prior clinical data from which to base statistical powering assumptions. Hence, this study was not powered to detect statistical significance. This study does provide the necessary clinical data for powering assumptions for the next study of MN-166 in ALS.
  • No cluster of adverse events was differentially present in MN-166 treatment and placebo treatment subjects.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with the positive interim data, particularly the ALSFRS-R data, which indicates that MN-166 has potential to slow disease progression in ALS patients. We believe the results for the bulbar subscore are particularly impressive as bulbar...


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