Clinical Trials

GlaxoSmithKline's Duchenne MD drug mirrors placebo effect in PhIII

   October 7, 2013 | By John Carroll
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   endpoint for improved walking distances in a 6-minute test but also
   flunked out on three separate secondary endpoints, with the outcomes
   looking almost identical in each case with a placebo.

   After 48 weeks of therapy, says Kraus, the drisapersen group suffered a
   decline in walking distance, just as the placebo arm did. The decline
   was 10.3 meters in the drug arm's favor, falling short of a significant
   improvement and well off the more than 30-meter improvement seen in
   Phase II. Using the North Star Ambulatory Assessment test, the placebo
   arm scored 6.7 compared to a close 7.2 score for drisapersen. A
   velocity test gauging the time to climb four stairs was also virtually
   identical--a 0.12 decline in the placebo arm and a 0.14 decline in the
   drug group. There was a near mirror-image decline in the rate of
   patients' 10-meter walk/run velocity gauge.