Alnylam Initiates Phase II Clinical Trial to Evaluate Safety and Anti-viral Efficacy of ALN-RSV01 in the Treatment of Respiratory Syncytial Virus (RSV) Infection
Tuesday June 26, 8:00 am ET
New Study Represents an Important Advancement in the Development of a Novel RNAi Therapeutic to Treat Viral Disease
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, today announced that it has initiated a Phase II experimental infection trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection. This trial is designed to evaluate the safety, tolerability, and anti-viral activity of ALN-RSV01 in adult subjects experimentally infected with RSV. ALN-RSV01 is the industry's most advanced RNAi therapeutic program for the treatment of an infectious disease and is an Alnylam proprietary program.
This new Phase II study represents an important component of Alnylam's clinical development plan for ALN-RSV01. At the 2007 Pediatric Academic Societies meeting in May, the company demonstrated the establishment of a model for the safe and reliable RSV infection of the upper respiratory tract of adult volunteers. Results showed that a robust and quantifiable infection was observed in 72 percent of subjects. The current Phase II trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and anti-viral activity of ALN-RSV01 administered to healthy adult volunteers experimentally inoculated with RSV. A total of approximately 90 subjects are expected to be enrolled in the trial which will evaluate the effects of ALN-RSV01 on the following parameters of RSV infection: incidence of infection; measures of viral load; and occurrence of clinical symptoms. In the study, ALN-RSV01 will be administered both before and after inoculation with RSV; drug, virus, and placebo will all be administered intranasally. Data from this trial are expected toward the end of the year.
"Initiation of this well-controlled Phase II trial represents an important milestone in our efforts to advance ALN-RSV01 as an anti-viral drug for the treatment of RSV infection in patients. Experimental infection models have been used to develop many anti-viral treatments including those for flu and the common cold, and we believe that such a model is a significant advancement for the development of novel anti-RSV therapies," said Akshay Vaishnaw, M.D., Ph.D., Vice President, Clinical Research of Alnylam. "This step in our clinical development plan for ALN-RSV01 is particularly exciting as it offers the opportunity to demonstrate human proof-of-concept with an RNAi therapeutic in a viral disease."
"Working with Alnylam has been very gratifying as we have rapidly advanced ALN-RSV01 from pre-clinical studies to this Phase II study. To go from proof-of-concept in a rodent model to the potential for proof-of-concept in humans in such a short time is an important step forward in the development of ALN-RSV01 for the treatment of RSV infection," said John P. DeVincenzo, M.D., Associate Professor of Pediatrics and Infectious Diseases at the University of Tennessee Health Science Center. "Most importantly, the initiation of this new clinical study has the potential to advance the development of ALN-RSV01 for both adult and pediatric patients suffering from RSV infection, a disease with urgent need for viable treatment options."
In clinical trials to date, ALN-RSV01 has been found to be safe and well tolerated when administered intranasally in relevant doses to human adult volunteers where it demonstrated a safety profile comparable to placebo. Alnylam is currently enrolling subjects in the U.S. in a Phase I inhalation safety study with data expected in the second half of this year. |
