Friday, December 7, 2012

Mitsubishi Tanabe initiates dose finding study on MT-1303 in Multiple Sclerosis

MT-1303 is a Sphingosine 1-phosphate (S1P) receptor, a follow on to Gilenya which is already approved for the treatment of MS. MT-1303 is supposed to have lower side effects than Gilenya

The primary objectives of the study are:
  • To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
  • To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS
The study is expected to complete in March 2015.

Inclusion Criteria
  1. RRMS as defined by the revised McDonald criteria
  2. Evidence of recent MS activity defined as either: 
  • at least one documented relapse in the previous 12 months, OR
  • a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
  • at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
  • Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
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