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news.Alnylam Pharmaceuticals, a RNAi therapeutics company has reported positive top-line results from Gemini, a ALN-RSV01 Phase II experimental infection study. The data showed that ALN-RSV01 was safe and well tolerated and demonstrated statistically significant anti-viral activity.
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The Gemini study was designed to evaluate the safety and anti-viral activity of ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. The Gemini study was a double-blind, placebo-controlled, randomized study of ALN-RSV01 or placebo in 88 adult subjects experimentally infected with a wild type clinical strain of RSV. The study was performed using ALN-RSV01 or placebo administered intranasally for five consecutive days -two days prior and three days after viral inoculation.
John Maraganore, CEO of Alnylam, said: “We look forward to advancing this program to its next stage of development, a Phase II study in naturally infected adult patients, which we expect to initiate in the first half of 2008.”