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Early Phase II Data Shows Alnylam RSV Drug to Be Safe, Well-Tolerated

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Alnylam Pharmaceuticals this week announced that preliminary data from a phase II trial of its siRNA-based respiratory syncytial virus treatment ALN-RSV01 has shown the drug to be safe and tolerable, the primary endpoints of the study.

Detailed efficacy data, however, were not available since the trial was not designed to measure such outcomes, the company added.

In the trial, 24 lung-transplant patients with confirmed RSV infections were randomized to receive inhaled ALN-RSV01 or placebo once daily for three consecutive days, according to the company.

"There were no drug-related serious adverse events or discontinuations, and there were no clinically significant differences in the overall adverse event profile between ALN-RSV01 and placebo," Alnylam said. "Further, patients treated with ALN-RSV01 showed no significant increases in plasma cytokine levels and showed no changes in lung function post-dosing as determined by spirometry."

Additionally, there was no evidence of disease exacerbation associated with ALN-RSV01 treatment, the company noted.

In the trial, "we also collected data on viral dynamics and clinical symptoms, although these measurements are secondary endpoints that are exploratory in nature due to the small study size and an imbalance in certain baseline characteristics between treatment groups," Akshay Vaishnaw, Alnylam senior vice president of clinical research, said in a statement.

News of the phase II data comes six about six months after Alnylam licensed to Cubist Pharmaceuticals the rights to market ALN-RSV01 worldwide except for Asia, where Japanese drugmaker Kyowa Hakko Kogyo holds the rights (see RNAi News, 1/15/2009 & 6/19/2008).

Today in a statement, Cubist CSO Steven Gilman said that his company is "encouraged by these important safety results in this program in support of the continued advancement of our overall ALN-RSV program.

"In the next several months, we will be reviewing data from these and other studies related to specific plans for the advancement of our overall ALN-RSV program," he added.

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