Sirnaomics Announces Positive Interim Results for Phase I Clinical Study of RNAi Therapeutic STP122G Targeting Factor XI

09 July 2024 | Tuesday | News

Cohort 2 of Phase I Trial Shows Promising Safety and Efficacy for Novel Anticoagulation Agent, Advancing to Next Dosing Cohort with No Serious Adverse Events
Image Source : Public Domain

Image Source : Public Domain

Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics,  announced the interim results for successful completion of the second cohort of its Phase I clinical study of GalNAc-based RNAi therapeutic STP122G, targeting Factor XI as a novel form of anticoagulation agent.

The Cohort 2 is comprised of eight healthy participants who completed dosing of 50 mg via subcutaneous administration and were followed over a period of 140 days. Safety data showed there were no dose-limiting toxicities or serious adverse events, with a dose dependent target silencing activity, so the study will proceed to the next dosing cohort. Sirnaomics plans to enroll up to a total of five escalating dosing cohorts. The Phase I, multicentred, randomized, double-blind, sequential cohort study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose of STP122G when administered subcutaneously to healthy participants. The safety and tolerability will be compared among five different doses of STP122G (25 mg, 50 mg, 100 mg, 200 mg, 400 mg) to select one for future studies. The target silencing activity and therapeutic benefit will also be measured and compared for dose-dependent evaluation. The study plans to recruit 40 total participants.

"STP122G is the first candidate based on the Group's GalAhead™ mxRNA technology targeting Factor XI for anticoagulation application." said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "STP122G may have a broad range of conditions that would benefit from a novel form of anticoagulation therapy such as prevention of deep vein thrombosis, treatment of atrial fibrillation for stroke prevention, and treatment of pulmonary embolism. The clinical studies with the first two cohorts of 16 healthy participants have demonstrated an excellent safety profile and a dose-dependent Factor XI silencing activities."

STP122G is a third-generation Factor XI inhibitor in cases of prior treatments have not completely prevented bleeding for patients with anticoagulant disorders. Factor XI is an enzyme produced predominantly by hepatocytes in the liver and it plays an important role in the body's blood clotting cascade. By inhibiting Factor XI, STP122G may have a better safety profiles than current anticoagulant drugs. There are three types of Factor XI inhibitors currently on the market or in clinical trials: RNA-based, small molecule, and monoclonal antibody treatments. As an RNA-based treatment driven by Sirnaomics' GalAhead™ mxRNA delivery system, STP122G targets the hepatocyte to inhibit the production of Factor XI, which could offer long-term efficacy and less risk of bleeding.


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