Sarepta Therapeutics, Inc.
) reported results through week 144 from a phase IIb study (Study
202: a long-term open-label extension study) on its lead candidate,
eteplirsen, being developed for the treatment of Duchenne muscular
Sarepta's shares tumbled 12.9% following the news. The study's 144
week data was comparatively weaker than the 120 week data reported
in Jan 2014.
Results from the study through 144 weeks revealed that patients
under eteplirsen cohorts (30 mg/kg and 50 mg/kg) being able to
perform a 6-minute walk test experienced a decline of 33.2 meters
from baseline in walking ability. However, a statistically
significant benefit of 75.1 meters was observed in modified
Intent-to-Treat (mITT) population (n=6) compared with the
placebo/delayed-treatment cohort (n=4), who started treatment with
eteplirsen at week 25 after 24 weeks of placebo treatment.
Meanwhile, Sarepta's previously reported 120-week data showed that
patients under eteplirsen cohorts experienced a decline of 13.9
meters from baseline in walking ability as against a statistically
significant benefit of 64.9 meters in mITT population compared with
the placebo/delayed-treatment cohort, who started treatment with
eteplirsen at week 25 after 24 weeks of placebo therapy.
Sarepta shares had soared over 39% earlier this year after it
announced that it would submit a New Drug Application (NDA) to the
FDA for eteplirsen in the DMD indication by year end. Sarepta's
decision on the filing of regulatory application for eteplirsen was
based on a guidance letter from the FDA. In Nov 2013, the FDA had
stated that the NDA filing of eteplirsen would be premature at that
time. The company met with the FDA several times before receiving
the guidance letter.
The company maintained its stance that it will be filling for
eteplirsen by year end. However, we remain concerned about the
relatively weaker results at week 144 compared to that of week 120.
Sarepta shares may drop further if any other disappointing news on
its lead candidate emerges.
Sarepta Therapeutics currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
The Medicines Company
Synergy Pharmaceuticals, Inc.
). All three stocks carry a Zacks Rank #1 (Strong Buy).
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