Sirnaomics Ltd. announced today dose administration for the first subject in a U.S. Phase I clinical trial of the Company’s systemic siRNA (small interfering RNA) therapeutic, STP707, for the treatment of liver fibrosis in primary sclerosing cholangitis with intravenous (IV) administration.
The single-center, randomized, dose-escalation, sequential cohort study is evaluating the safety, tolerability and pharmacokinetics of STP707, administered intravenously in healthy volunteers as a single ascending dose. Subjects are divided into four cohorts, of which Cohort A will receive a 3mg dose via IV infusion, Cohort B will receive 6mg, Cohort C will receive 12mg, and Cohort D will receive 24mg. The study is enrolling up to 50 healthy subjects between the ages of 18 to 55 years old.
“This Phase I study is a crucial step forward in our liver fibrosis drug development program and will allow us to gather very important data on safety and dosing that will support our future studies utilizing STP707 for the treatment of liver fibrosis due to primary sclerosing cholangitis. This study will allow us to expand our understanding of how this therapeutic candidate can impact more patients with rare disorders that are in need of effective treatments,” said Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux M.D.
“As the most severe type of liver fibrosis, evaluating STP707 for the treatment of primary sclerosing cholangitis, will bring hope to a massive patient population suffering various types of liver fibrosis, and with tremendous unmet medical needs. This is a key milestone for Sirnaomics in our development of an IV formulation of this siRNA therapeutic product for chronic disease treatment,” commented Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics.