Alnylam starts ALN-RSV01 clinical program

Massachusetts, USA-based Alnylam Pharmaceuticals has initiated a human experimental infection study with respiratory syncytial virus designed to establish a safe and reliable RSV infection of the upper respiratory tract in adult volunteers. On determination of the optimal level of RSV inoculum, Alnylam plans to initiate a subsequent clinical protocol to evaluate the antiviral activity for ALN-RSV01, an RNAi therapeutic being developed for the treatment of RSV infection. The company says that ALN-RSV01 is the industry's most advanced RNAi therapeutic program for the treatment of an infectious disease and is an Alnylam proprietary program.

The experimental infection study is designed to safely and reliably establish infection in healthy adult volunteers. Around 40 subjects are planned to be enrolled into the study, where gradually increasing levels of virus will be used to determine the optimal infectious inoculum. Following determination of the optimal level of the RSV inoculum, Alnylam expects the next stage of this program will be performed with a separate clinical protocol using ALN-RSV01 in order to investigate the drug's antiviral properties.