Sarepta Therapeutics Inc.
) shares are slowly climbing following the announcement of
encouraging additional data from a phase IIb open label extension
study (Study 202) on eteplirsen for the treatment of patients
suffering from Duchenne muscular dystrophy (DMD).
The study had met its primary endpoint of increased novel
dystrophin at week 48 - these results were presented earlier. 96
week data showed continued stability of walking ability in
Post 96 weeks of treatment, patients taking 30 mg/kg and 50
mg/kg doses of eteplirsen experienced less than a 5% decline from
baseline in walking ability as measured by the 6-minute walk test
(6MWT). A statistically significant treatment benefit of 70.8
meters was observed as compared to placebo.
According to information provided by Sarepta, roughly one in
every 3,500 boys globally is affected by DMD.
Sarepta intends to file a New Drug Application (NDA) for
eteplirsen in the first half of 2014 with the U.S. Food and Drug
Administration (FDA).The decision to file the NDA was based on
productive interactions with the FDA including a meeting with the
agency in July.
We note that several other companies including
) are developing therapies targeting the DMD market. However, a
few days back, a phase III study being conducted by Prosensa
failed to meet the primary endpoint as Prosensa's drisapersen did
not show statistically significant improvement in the 6MWD test
versus placebo. Sarepta shares climbed 18% on the drisapersen
Sarepta currently has a Zacks Rank #2 (Buy). Currently,
) look more attractive with a Zacks Rank #1 (Strong Buy).
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