Arbutus Biopharma’s (NASDAQ:ABUS) lipid nanoparticle (LNP) licensee, Alnylam Pharmaceuticals (NASDAQ:ALNY), announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints.
The program represents the most clinically advanced application of Arbutus’ proprietary LNP delivery technology. Alnylam intends to file a NDA in late 2017 and a Marketing Authorization Application in Europe in early 2018.
Under terms of the LNP license agreement for patisiran, Arbutus will be eligible for single-digit royalties on sales of patisiran.
In a statement, Dr. Mark Murray, president and CEO of Arbutus, said the successful Phase 3 study of patisiran is an important achievement for patients and for the field of RNAi therapeutics.
“These data provide further validation of the utility of our leading LNP technology,” he added. “Our LNP technology represents the most proven delivery technology for the systemic delivery of nucleic acid-based therapeutics."