• 05 Apr 2022
• Admin
• News Article

Sirnaomics Doses First Subject in Phase I Clinical Trial of STP707 for the Treatment of Liver Fibrosis in Primary Sclerosing Cholangitis

Sirnaomics Ltd.a leading biopharmaceutical company in discovery and development of RNAi therapeutics, 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.STP707 is composed of two siRNA oligonucleotides, targeting TGF-?1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics' STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA's produces a synergistic effect that diminishes pro-inflammatory factors. Over-expressions of TGF-?1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, IV administration resulted in knock-down of TGF-?1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics for its core product, STP705. Learn more at www.sirnaomics.com.