Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced that it has published results from its Phase II GEMINI study in the Proceedings of the National Academy of Sciences (PNAS) (DOI: 10.1073/pnas.0912186107). These data, previously presented at the International Symposium on Respiratory Viral Infections in Singapore in 2008, showed human proof of concept with an RNAi therapeutic in a randomized, double blind, placebo-controlled study. In this study, treatment with ALN-RSV01 showed statistically significant anti-viral activity, including a decreased RSV infection rate and an increase in the number of subjects who remained free of infection.

"The positive results generated from GEMINI established encouraging human proof of concept with an RNAi therapeutic," said Akshay Vaishnaw, M.D., Ph.D., Senior Vice President, Clinical Research at Alnylam. "GEMINI also set the stage for us to advance ALN-RSV01 into the naturally RSV-infected adult lung transplant population where we are currently conducting a Phase IIb clinical study. We are encouraged by the cumulative data to date in this program and look forward to the program's continued advancement."

GEMINI was a double blind study, where 88 adult subjects experimentally infected with RSV were randomized to receive ALN-RSV01 or placebo. Administration of ALN-RSV01 resulted in statistically significant anti-viral activity with a 38% relative reduction in RSV infection rate (p