Sirnaomics Announces Interim Results for Successful Completion of the Second Cohort of Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Therapeutics

2024-07-08

临床1期临床结果临床申请siRNA免疫疗法

HONG KONG and GERMANTOWN, Md. and SUZHOU, China, July 8, 2024 /PRNewswire/ --

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, today 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.

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

About STP122G

STP122G is Sirnaomics' leading GalAhead™ mxRNA drug candidate, targeting Factor XI for anticoagulation therapeutics. 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. The Group launched the second cohort study in January 2024 and has seen an excellent safety readout and a dose-dependent silencing activity of Factor XI. 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

Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with 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: Polypeptide Nanoparticle Formulation and the 2nd generation of GalNAc conjugates, the Group has established an enriched drug candidate pipeline. Sirnaomics is advancing RNAi therapeutics for oncology application with multiple successes of its clinical programs for STP705 and STP707. STP122G represents the first drug candidate of GalAhead™ technology entering clinical development. With the expansion of the Group's clinical pipeline and establishment of the Group's manufacturing facility, Sirnaomics is still focusing on a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.

SOURCE Sirnaomics