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Sarepta Therapeutics, Inc. Message Board

  • immediatereliefxxx immediatereliefxxx Aug 16, 2013 7:56 AM Flag

    Significance of the Prosensa data release

    Many of you are undoubtedly waking up to the news that GSK finally issued more data from its Phase II trial of Prosensa's Drisapersen. Drisapersen, for any newbies, is a drug considered to be in direct competition with Sarepta. Since Prosensa (RNA)'s IPO many investors became worried that Sarepta would have problems, given that drisapersen was further along in trials. Turns out the worries were overblown. Drisapersen (unlike Sarepta's eteplirsen) simply isn't a very good drug.

    The most important piece of news from the data release was that Drisapersen simply isn't as good at generating the key protein dystrophin as Eteplirsen. In fact, by week 25, only 72% of patients on continuous dosing showed increased dystrophin. Only 59% of patients on intermittent dosing showed same. We don't know why the effect is more muted. Possibly due to the low dosing required by drisapersen's dangerous side effects. Possibly due to the larger drisapersen molecule having more difficulty penetrating cells.

    Note that the data also reiterated the FAILURE of Drisapersen to attain statistical significance in clinical outcomes as well. I leave off with a direct quote from the data:

    At Week 25, no statistically significant treatment benefit (3.51 m) over placebo in 6MWD was observed for the intermittent regimen. At Week 49, a treatment difference (similar magnitude to Week 25 of 35.84 m) over placebo in 6MWD was observed for the continuous regimen, though the results were no longer statistically significant due to increased variability. At Week 49, a treatment benefit (27.08 m) over placebo in 6MWD was observed for the intermittent regimen, although the results were not statistically significant

    Sentiment: Strong Buy

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