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news.Biotech firm Alnylam Pharmaceuticals has initiated a phase I study in Europe to evaluate the safety and pharmacology of its RNAi therapeutic drug candidate to treat infection by the respiratory syncytial virus.
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The study will look at the effects of ALN-RSV01 in healthy volunteers in two separate phase I trials. The first trial underway in Europe and is expected to enroll 57 healthy adult male volunteers. The regulatory application for the second trial, to be conducted in the US, has cleared the 30-day review period by the FDA and is expected to begin by the end of the month.
“There is a significant need for novel therapeutics to effectively treat patients with RSV infection, a cause of serious disease and hospitalization in infants, the elderly, and others with compromised immune systems,” said Dr John DeVincenzo, associate professor of pediatrics at the University of Tennessee Health Science Center. “Based on its novel mechanism of action and impressive preclinical efficacy data, ALN-RSV01 may represent a breakthrough treatment option for patients infected with RSV.”
During the trial, 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 US 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 expects to have preliminary data available from these trials in the first half of 2006.