Sirnaomics Announces Successful Completion of Cohort 1 from Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Treatment

HONG KONG and GERMANTOWN, Md. and SUZHOU BIOBAY, China, Dec. 6, 2023 /PRNewswire/ -- 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.

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.

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05844293.

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About STP122G

STP122G is Sirnaomics' leading GalAhead™ Factor XI RNAi drug candidate. Sirnaomics submitted a U.S. IND for STP122G in March 2023 and launched a Phase I clinical trial in April 2023 as part of the Group's Factor XI Program. This program is applicable across a broad range of disease indications such as an anticoagulation, prevention and treatment of stroke after atrial fibrillation, cancer after immunotherapy, and improving total knee replacement recovery. STP122G is the inaugural candidate utilizing Sirnaomics' proprietary GalNAc RNAi platform technology, GalAhead™.

About Sirnaomics (stock code: 2257)

Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Company's GalAhead™ technology, is currently in Phase I development. The Company has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the establishment of the Group's manufacturing facility in China, Sirnaomics is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com .