Alnylam Pharmaceuticals, Inc.
) recently presented complete results from a phase IIb trial on
ALN-RSV01 at the European Respiratory Society's (ERS) Annual
Meeting. The candidate failed to achieve the primary end point of
the phase IIb trial.
However, the candidate demonstrated significant treatment
effect. Alnylam will provide an update on its development plans for
ALN-RSV01's by the end of 2012 after discussing the complete
results from the trial with regulatory authorities.
The randomized, double-blind, placebo-controlled phase IIb trial
enrolled 87 patients. The reduction in the occurrence of new or
progressive bronchiolitis obliterans syndrome (BOS) at 180 days was
the primary endpoint of the trial, which the candidate failed to
achieve. However, the candidate showed a statistically significant
reduction in BOS at 90 days and was found to be generally safe and
well tolerated in the trial.
Alnylam has collaborated with Kyowa Hakko Kirin Co. for the
development of ALN-RSV01 in Asia and with
Cubist Pharmaceuticals Inc.
) in the rest of the world.
Alnylam makes use of the potentially revolutionary RNAi technology,
a natural cellular process for selectively turning off the activity
of genes, to build a pipeline to treat a wide array of diseases. In
January 2011, Alnylam launched its "Alnylam 5X15" strategy aimed at
developing RNAi therapeutic products for the treatment of
genetically defined diseases addressing major unmet medical
Alnylam expects to have five such RNAi therapeutic programs in
advanced clinical development by the end of 2015. We expect
investor focus to remain on the company's pipeline progress.
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The major programs under development are ALN-PCS
(hypercholesterolemia), second generation ALN-TTR
(transthyretin/TTR-mediated amyloidosis/ATTR), ALN-HPN (refractory
anemia), ALN-AT3 (hemophilia) and ALN-TMP (hemoglobinopathies).
Alnylam also has collaborations or deals with players, such as
Biogen Idec Inc.
Roche Holding AG
) to further develop and utilize its core technology.
The stock carries a Zacks #3 Rank (Hold rating) in the short