Alnylam begins phase 1 study of ALN-RSV01 for respiratory syncytial virus infection

New York, Dec. 7 - Alnylam Pharmaceuticals, Inc. said it has started a phase 1 study in Europe to evaluate the human safety and pharmacology of ALN-RSV01 in healthy volunteers.

Additionally, the company's Investigational New Drug application to conduct a separate phase 1 trial in the United States has cleared the 30-day review period by the Food and Drug Administration and the U.S. study is expected to begin by the end of the month.

ALN-RSV01 is an RNA interference (RNAi) therapeutic designed to selectively and potently silence the nucleocapsid N gene in the respiratory syncytial virus. Respiratory syncytial virus is a highly contagious virus that causes infections in both the upper and lower respiratory tract. It infects nearly every child at least once by the age of two years and is a major cause of hospitalization due to respiratory infection in children and people with compromised immune systems, and others.

"The initiation of this phase 1 study represents significant progress in the field of RNAi as it is the first clinical trial of an RNAi therapeutic to treat an infectious disease," said John Maraganore, president and chief executive officer of Alnylam, in a news release.

"Importantly, this trial also marks Alnylam's transition to a clinical-stage company and is a major milestone in our continued effort to develop a pipeline of RNAi therapeutics to address major unmet medical needs."

The European trial is expected to enroll 57 healthy adult male volunteers. Drug or placebo will be administered intranasally in both single ascending doses across three cohorts and in multiple ascending doses daily for five consecutive days across three cohorts.

The second trial in the United States is expected to enroll 35 healthy adult male volunteers. Drug or placebo will be administered intranasally in single ascending doses across five cohorts.

In both studies, ALN-RSV01 will be evaluated for safety, tolerability, and pharmacokinetics.

Alnylam, based in Cambridge, Mass., expects to have preliminary data available from these trials in the first half of 2006.

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