Alnylam Pharma initiates APOLLO-B phase III trial of Onpattro to treat transthyretin amyloidosis with cardiomyopathy.

Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced that the Company has initiated APOLLO-B, a global Phase III 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.

APOLLO-B Phase III Study Design : The APOLLO-B Phase III 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.