Alnylam Pharma (ALNY) Says DMC Recommends Continuation of Phase 3 APOLLO Trial
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Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced today that the Data Monitoring Committee (DMC) for the Phase 3 APOLLO study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN) met on October 7, 2016 and recommended continuation of the trial without modification. The APOLLO DMC met at the request of the Company following the decision – announced on October 5, 2016 – to discontinue development of revusiran for the treatment of hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM). The DMC will continue to meet periodically per their remit to monitor the overall safety of patisiran in the APOLLO study through its completion.
The APOLLO study has completed enrollment of 225 patients at 44 sites in 19 countries, between December 2013 and January 2016.
“As part of our vigilance around patient safety, we felt it was important to take immediate action and requested that the APOLLO DMC convene to evaluate accumulated safety data from the randomized, placebo-controlled Phase 3 study of patisiran,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President of R&D and Chief Medical Officer at Alnylam. “We’re pleased to learn of the DMC’s recommendation that dosing can continue in APOLLO, and we look forward to the top-line data readout from that study expected in mid-2017. There is substantial unmet need in hATTR-PN and we are committed to advancing patisiran through development in hopes of bringing a new and needed treatment option to patients.”
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