ALN-RSV01: Final Phase II data

Final data from 87 lung transplant patients in the intent-to-treat (ITT) population of a double-blind, international Phase IIb trial showed once-daily 0.6 mg/kg inhaled ALN-RSV01 for 5 days plus standard of care met the secondary endpoint of reducing the incidence of new or progressive bronchiolitis obliterans syndrome at 90 days post-RSV infection vs. placebo plus standard of care (15.9% vs. 33.3%, p=0.044). Alnylam said there was no significant difference between the arms on other secondary endpoints, including viral parameters and symptom score. ALN-RSV01 also significantly reduced the incidence of new or progressive bronchiolitis obliterans syndrome at 180 days post-RSV infection in patients treated within 5 days from symptom onset (8% vs. 71%, p=0.0095), but did not significantly reduce the incidence in patients treated >=5 days after symptom onset (16% vs. 19%, p=0.74) vs. placebo. Data were presented at the European Respiratory Society meeting in Vienna. ...