Alnylam Pharmaceuticals, Inc. ALNY announced that it has initiated the final part of the phase I/II study on ALN-CC5 for the treatment of patients with complement-mediated diseases.
The open-label, multi-dose study will evaluate ALN-CC5, administered for up to 13 weeks, on patients with paroxysmal nocturnal hemoglobinuria (PNH). Initial data from the study is expected in mid-2016. The company plans to initiate phase III studies in 2017.
We remind investors that the phase I/II study on ALN-CC5 is being conducted in three parts – Part A, B and C. The randomized, double-blind, placebo-controlled Part A and Part B studies evaluated the candidate in healthy adult volunteers in single-ascending and multiple-ascending doses, respectively. Results from both parts revealed that the candidate was generally well tolerated in patients.
We note that Alnylam has an agreement with Genzyme Corporation, a Sanofi SNY company, for the development and commercialization of RNAi therapeutics targeting rare diseases. As per the terms of the agreement, Alnylam holds rights in North America and Western Europe, while Genzyme has rights to access certain programs in Alnylam's current and future Genetic Medicines pipeline, including ALN-CC5, in the rest of the world.
Meanwhile, Alnylam continues to progress with its pipeline candidates. Earlier this month, the company announced positive results from a phase I study on fitusiran (ALN-AT3) for the treatment of patients with hemophilia A and B, and rare bleeding disorders. Currently, the company is enrolling patients in a phase I open-label extension study on fitusiran and expects to present data every year starting from 2016. Alnylam also expects to initiate a phase III program on the candidate in mid-2016 for hemophilia A and B, including patients with and without inhibitors.
Alnylam currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector includes Anika Therapeutics Inc. ANIK and Achillion Pharmaceuticals, Inc. ACHN both sporting a Zacks Rank #1 (Strong Buy).
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