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

By Angela McDaniels

Seattle, Dec. 19 - Alnylam Pharmaceuticals Inc. said it has begun a phase 1 study in the United States to evaluate the safety and pharmacology of ALN-RSV01, an RNAi therapeutic for respiratory syncytial virus infection (RSV).

"RSV infection is a cause of serious disease and hospitalization in infants, the elderly, and others with compromised immune systems," president and chief executive officer John Maraganore said in a company news release.

"ALN-RSV01 has the potential to be a novel approach for the treatment of RSV, an area where an effective anti-viral is clearly needed. We look forward to continuing to advance this important program through the clinic. We expect that combined results from our two phase 1 studies will provide us with safety data from over 90 volunteers, representing one of the most extensive human clinical experiences with an RNAi therapeutic."

Alnylam is conducting two phase 1 trials with ALN-RSV01. The trial underway 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.

The second trial, underway in Europe, was designed 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.

In both studies, ALN-RSV01 will be evaluated for safety, tolerability and pharmacokinetics. Alnylam said it expects to have preliminary data available from these trials in the first half of 2006.

ALN-RSV01 is a small interfering RNA that is designed to selectively silence the respiratory syncytial virus' nucleocapsid N gene, which is essential for viral replication, the company said.

The respiratory syncytial virus is highly contagious and 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 in children and people with compromised immune systems, the company said.

Alnylam is a biopharmaceutical company based in Cambridge, Mass., that develops therapeutics based on RNA interference, a naturally occurring mechanism within cells for selectively silencing and regulating genes.

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