PARI's eFlow, an advanced electronic nebulizer, was optimized and used to deliver Alnylam's ALN-RSV01 in a Phase I human clinical trial. Results of the Phase I trial were announced at the 18th Annual Drug Delivery to the Lungs meeting held in Edinburgh, U.K.
ALN-RSV01 is an RNAi therapeutic being developed as a treatment for respiratory syncytial virus (RSV) infection, the leading cause of pediatric hospitalization in the U.S. and a prevalent infection in immune-compromised adults. RSV currently does not have a viable treatment option. The Phase I study represents the first-ever clinical study of an RNAi therapeutic administered via inhalation.
"With the flexibility of the eFlow platform, we are collaborating with a number of pharmaceutical companies to develop new respiratory therapies that are delivered to the lungs in a faster, more effective manner. We hope that working with Alnylam on a treatment for RSV will open up a new treatment option to meet this unmet need," said Geoff Hunziker, President of eFlow LLC.
Alnylam's Phase I study for ALN-RSV01 was a randomized, double-blind, placebo-controlled trial in healthy adult volunteers to assess the safety, tolerability, and pharmacokinetics of ALN-RSV01 administrated by inhalation via nebulizer.
All major objectives of the trial were met, including definition of a safe and well-tolerated dose and regimen for advancement of ALN-RSV01 into further Phase II development. Importantly, data showed that the efficiency of delivery of ALN-RSV01 delivered via inhalation, as measured by plasma levels, was significantly greater in humans than observed pre-clinically.