Sirnaomics Reports Successful Phase I Interim Results for RNAi Therapeutic STP122G

July 8, 2024 -- Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceutical company specializing in the discovery and development of advanced RNAi therapeutics, has announced the successful completion of the second cohort in its Phase I clinical study of GalNAc-based RNAi therapeutic STP122G. This therapeutic agent is designed to target Factor XI as a novel anticoagulation therapy.

The second cohort included eight healthy participants who were administered a 50 mg dose subcutaneously and monitored over a span of 140 days. The safety data indicated no dose-limiting toxicities or serious adverse events, along with a dose-dependent target silencing activity. This positive outcome allows the study to advance to the next dosing cohort. Sirnaomics has plans to enroll up to five escalating dosing cohorts in total. The Phase I, multicentered, randomized, double-blind, sequential cohort study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose of STP122G given subcutaneously to healthy participants. A comparison of safety and tolerability among five different doses of STP122G (25 mg, 50 mg, 100 mg, 200 mg, 400 mg) will be conducted to select the most appropriate dose for future studies. Additionally, the target silencing activity and therapeutic benefits will be evaluated in a dose-dependent manner. The study plans to recruit a total of 40 participants.

Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President, and CEO of Sirnaomics, stated, "STP122G is our first candidate based on the Group's GalAhead™ mxRNA technology, targeting Factor XI for anticoagulation. This therapeutic has the potential to be beneficial for various conditions requiring novel anticoagulation therapy, such as preventing deep vein thrombosis, treating atrial fibrillation for stroke prevention, and managing pulmonary embolism. The clinical trials with the first two cohorts of 16 healthy participants have shown excellent safety profiles and dose-dependent Factor XI silencing activities."

STP122G is a third-generation Factor XI inhibitor, developed for cases where previous treatments have failed to completely prevent bleeding in patients with anticoagulant disorders. Factor XI, an enzyme primarily produced by hepatocytes in the liver, is crucial in the blood clotting process. By inhibiting Factor XI, STP122G may offer improved safety profiles over current anticoagulant drugs. There are three types of Factor XI inhibitors available or under clinical trials: RNA-based, small molecule, and monoclonal antibody treatments. As an RNA-based treatment leveraging Sirnaomics' GalAhead™ mxRNA delivery system, STP122G targets hepatocytes to inhibit Factor XI production, potentially offering long-term efficacy and a reduced risk of bleeding.

STP122G is Sirnaomics' leading GalAhead™ mxRNA drug candidate, designed for anticoagulation therapeutics. Sirnaomics submitted a U.S. IND for STP122G in March 2023 and commenced a Phase I clinical trial in April 2023 as part of the Group's Factor XI Program. The second cohort study, launched in January 2024, has demonstrated excellent safety and dose-dependent silencing activity of Factor XI. This program targets a variety of conditions, including anticoagulation, stroke prevention after atrial fibrillation, cancer post-immunotherapy, and enhancing recovery after total knee replacement. STP122G is the first candidate utilizing Sirnaomics' proprietary GalNAc RNAi platform technology, GalAhead™.

Sirnaomics is an RNA therapeutics biopharmaceutical company with a strong presence in both Asia and the United States. The Group's proprietary delivery technologies, including Polypeptide Nanoparticle Formulation and GalNAc conjugates, have enabled the development of a robust drug candidate pipeline. Sirnaomics is driving RNAi therapeutics for oncology applications, with multiple successful clinical programs for STP705 and STP707. STP122G marks the first drug candidate of the GalAhead™ technology to enter clinical development. With the expansion of its clinical pipeline and the establishment of a manufacturing facility, Sirnaomics is transitioning from a biotech company to a biopharma corporation.

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