Sirnaomics Initiates First-in-Human Dosing in Phase 1 Clinical Trial of STP707 for Primary Sclerosing Cholangitis-Associated Liver Fibrosis

Hong KongApril 4, 2022/PR Newswire/ -- Sirnaomics Ltd. (“Company”，“Sirnaomics”Sirnaomics, Inc. (Stock Code: 2257.HK) is a leading biopharmaceutical company focused on exploring and developing RNAi therapies. Sirnaomics today announced the initiation of a Phase I clinical trial in the United States for its small interfering ribonucleic acid (siRNA) drug candidate STP707, administered intravenously for the treatment of Primary Sclerosing Cholangitis (PSC), with the first subject having received systemic dosing.

This single-center, randomized, dose-escalation, sequential cohort study aims to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of STP707, administered as a single ascending dose intravenously in healthy volunteers. Participants are divided into four groups: Group A will receive a 3mg dose via intravenous infusion, Group B will receive 6mg, Group C will receive 12mg, and Group D will receive 24mg. The study has recruited up to 50 healthy subjects aged between 18 and 55.

Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux, M.D., said, "This Phase I clinical trial is a very important step in our drug development program for the treatment of liver fibrosis. It will allow us to gather critical data on safety and dosing, which will support our future research using STP707 to treat liver fibrosis caused by primary sclerosing cholangitis. This study will expand our understanding of how this therapeutic candidate impacts more patients with rare diseases who need effective treatments."”

Dr. Yang Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, Inc., said:“The evaluation of STP707 for the treatment of primary sclerosing cholangitis, the most severe type of liver fibrosis, brings hope to a large patient population suffering from various types of liver fibrosis and addresses a significant unmet medical need. This study represents a key milestone in Sirnaomics' development of this siRNA therapeutic product with an intravenous infusion formulation for the treatment of chronic diseases.”

For more information about Sirnaomics clinical trials, please visit the company's official website:www.sirnaomics.com。

AboutSTP707

STP707 consists of two small interfering RNAs (siRNAs) that target TGF-β1 and COX-2 mRNA, respectively, and are formulated into a nanoparticle formulation with a proprietary histidine-lysine copolypeptide (HKP+H) as the drug delivery carrier. This unique carrier differs from the one used in the STP705 product. Each individual siRNA is capable of inhibiting the expression of the corresponding target mRNA, and these two siRNAs can be used in combination to produce a synergistic effect. The overexpression of TGF-β1 and COX-2 plays a key regulatory role in tumorigenesis. In preclinical studies of STP707, intravenous administration resulted in the knockdown of TGF-β1 and COX-2 gene expression in organs such as the liver and lungs. Additionally, in preclinical model testing, STP707 demonstrated antitumor activity against various types of solid tumors.

AboutSirnaomics

Sirnaomics is an RNA therapeutics biopharmaceutical company with candidate products in preclinical and clinical stages, focusing on exploring and developing innovative drugs for the treatment of indications with unmet medical needs and significant market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics biopharmaceutical company to hold a strong market position in both China and the United States, and it is also the first company to achieve positive Phase IIa clinical results for its core product, STP705, an RNAi therapy in the field of oncology. For more information about the company, please visit:www.sirnaomics.com。

Contact Information:

Michael Molyneaux, MD, MBA
Executive Director and Chief Medical Officer of Sirnaomics
Email:michaelmolyneaux@sirnaomics.com

Investor Relations:

Ye Yongji
CFO of Sirnaomics China
Email:NigelYip@sirnaomics.com

U.S. Media Inquiry:

Mark Corbae
Phone: +1 203 682 8288
Email:Mark.Corbae@westwicke.com

Asia Media Inquiry:

Li Yaorong
Phone: +852 3150 6707
Email:sirnaomics.hk@pordahavas.com