Alnylam Pharmaceuticals says that its ALN-RSV01 inhaled RNAi drug failed to meet the primary endpoint of a Phase 2b study, not significantly reducing the incidence of bronchiolitis obliterans syndrome (BOS) at 180 days after infection in lung transplant patients infected with respiratory syncytial virus (RSV) in an “intent-to-treat” (ITTc) analysis, but that it met “last observation carried forward” and “per protocol” endpoints.
Alnylam Senior VP and Chief Medical Officer Akshay K. Vaishnaw commented, “We believe that these data provide important evidence that ALN-RSV01 reduces the incidence of new or progressive BOS in RSV-infected lung transplant patients, replicating the findings from our Phase 2a study of this agent in the same clinical setting. We plan to discuss the results of this study with US and European regulatory authorities later this year and, thereafter, determine appropriate next steps, if any, on our ALN-RSV program. In the meanwhile, we continue to execute on our ‘Alnylam 5×15’ product strategy with a focus on our transthyretin-mediated amyloidosis and hemophilia programs.”
In Asia, Alnylam is partnered with Kyowa Hakko Kirin on the RSV program; in the rest of the world, the company is partnered with Cubist Pharmaceuticals on the program.
Read the Alnylam press release.
