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Alnylam Pharmaceuticals Announces Initiation of APOLLO-B Phase 3 Study of Patisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy
– APOLLO-B Will Enroll Patients with Both Hereditary and Wild-Type Amyloidosis – CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq:
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n– APOLLO-B Will Enroll Patients with Both Hereditary and Wild-Type Amyloidosis –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company has initiated APOLLO-B, a global Phase 3 placebo-controlled clinical trial of patisiran, an intravenously administered RNAi therapeutic, for the treatment of transthyretin amyloidosis (ATTR amyloidosis) with cardiomyopathy. The primary endpoint is the change from baseline in the 6-minute walk test (6-MWT) at 12 months. Secondary endpoints will evaluate the efficacy of patisiran on quality of life using the Kansas City Cardiomyopathy Questionnaire Overall Summary, and composite endpoints of mortality and hospitalization.\n\n\n“ATTR amyloidosis is a rare, debilitating, and life-threatening disease encompassing hereditary ATTR (hATTR) amyloidosis and wild-type ATTR (wtATTR) amyloidosis. Based on the encouraging exploratory results on cardiac endpoints in the Phase 3 APOLLO study, we are investigating the potential for patisiran to treat cardiovascular-related manifestations of ATTR amyloidosis,” said Eric Green, Senior Vice President and General Manager, TTR Program. “The initiation of APOLLO-B represents a significant milestone in our commitment to explore the full potential of patisiran for patients living with all types of ATTR amyloidosis.”\n\n\nPatisiran is the non-branded drug name for ONPATTRO®. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union, Canada, and Japan.\n\n\nAPOLLO-B Phase 3 Study Design\nThe APOLLO-B Phase 3 trial is a randomized, double-blind, placebo-controlled multicenter global study designed to evaluate the efficacy and safety of patisiran in approximately 300 adult patients with ATTR amyloidosis (hereditary or wild type) with cardiomyopathy. Patients will be randomized on a 1:1 basis to receive 0.3 mg/kg of patisiran or placebo intravenously administered every three weeks over a 24-month treatment period. After 12 months, all patients will receive patisiran in an open-label treatment period. For more information on APOLLO-B (NCT03997383), including the full list of eligibility criteria, please visit www.clinicaltrials.gov, email clinicaltri...