Sirnaomics Successfully Completes Phase I Study for Anticoagulant RNAi Therapeutic STP122G

06 December 2023 | Wednesday | News

Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced the successful completion of Cohort 1 in an ongoing Phase I clinical trial of STP122G, targeting Factor XI as a novel form of anticoagulation.
Image Source : Public Domain

Image Source : Public Domain

Cohort 1 is comprised of eight subjects who completed dosing and were followed over a period of 140 days. Safety data showed there were no dose-limiting toxicities or serious adverse events, so the study will proceed to the next dosing cohort. Sirnaomics plans to enroll up to five escalating dosing cohorts.

The phase I, multicenter, 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 study plans to recruit 40 total participants.

"STP122G is the first candidate to move through clinical trials as part of our GalAhead™ Factor XI RNAi therapeutic program," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "By targeting Factor XI, STP122G may have applications across 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. There is a very large market opportunity for novel, safe anticoagulants and the benefits of siRNA therapies in relation to method of administration and longer duration of action should fit very well in the conditions we are targeting. We look forward to continuing to examine the efficacy of STP122G into 2024."

"The completion of the first-in-human, dosing cohort of our GalNAc-based platform is encouraging," said Dr. Francois Lebel, M.D., Chief Medical Officer of Sirnaomics. "As expected, the safety profile was found to be acceptable by prespecified protocol criteria and is allowing us to escalate further. In the next two or three dose cohorts, we expect to highlight the pharmacodynamic properties of this novel molecule directed at a validated target. The observation period between cohorts is related to the anticipated sustained pharmacologic effect of STP122G, a desirable characteristic for an anticoagulant."

STP122G is a third-generation Factor XI inhibitor in cases where 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 profile 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™ delivery system, STP122G targets the hepatocyte to inhibit the production of Factor XI, which could offer long-term efficacy and less risk of bleeding.

Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in