Alnylam Pharma Announces Its Initial 2017 Pipeline Goals - Quick Facts

(RTTNews) - Alnylam Pharmaceuticals, Inc. (ALNY), the leading RNAi therapeutics company, announced the company expects to report top-line data from the APOLLO Phase 3 trial in mid-2017 and additional results in late 2017. Assuming positive Phase 3 data, Alnylam plans to submit a New Drug Application and Marketing Authorisation Application for patisiran at year-end 2017. Patisiran is an investigational RNAi therapeutic in development for the treatment of hereditary ATTR amyloidosis with polyneuropathy.

Alnylam Pharma expects the ATLAS program to consist of three separate Phase 3 trials. The company plans to initiate the ATLAS Phase 3 program in early 2017 and present data from ongoing fitusiran trials in mid- and late 2017.

Alnylam also plans to continue support of The Medicines Company's advancement of inclisiran into Phase 3 studies in early and mid-2017.

Alnylam Pharma announced positive preliminary clinical data from its Phase 1 study of ALN-TTRsc02, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. The Phase 1 trial is a randomized, placebo-controlled, single ascending-dose study in healthy volunteers receiving fixed subcutaneous doses ranging from 5 mg to 300 mg.

Eric Green, Vice President, General Manager of the TTR Program, said: "Pending positive results from the APOLLO Phase 3 study of patisiran, we plan to engage regulators to align on a development path for ALN-TTRsc02."