HONG KONG, Germantown, Md. and Suzhou, China, June 2, 2023 /PRNewswire/ -- 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, today announced it has dosed the first participant in a Phase I clinical trial of STP122G for anticoagulation treatment. STP122G is part of the Group's GalAhead™ Factor XI RNAi therapeutic program, which has applications across a broad range of disease indications such as the potential prevention and treatment of stroke after atrial fibrillation, cancer patients after immunotherapy, and improving total knee replacement recovery.
The phase I, single-center, 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.
"This phase I study will focus on the safety of various doses of STP122G (Factor XI program) and it will also allow us to monitor the anticoagulation effect as well as the Factor XI reduction. These results will allow us to gain insight into efficacy to determine future safe and effective doses with our Factor XI program technology. Successful reduction in Factor XI activity will allow us the optionality to enter many diseases states where anticoagulant therapy is needed to manage or prevent illness such as Atrial Fibrillation, blood clot prevention in patients undergoing orthopedic procedures and blood clot prevention in patients with end stage renal disease receiving dialysis," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics.
Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics added, "STP122G is our first GalAhead™-based RNAi drug candidate and has been well-validated for its anticoagulant therapeutic potential with a remarkable efficacy using a non-human primate model. With Phase I clinical study on the drug started and the first participant's dosing completed, we are not only helping advance anticoagulant therapies, but also giving hope to a vast patient population with substantial unmet needs in the realm of anticoagulation disorders."
STP122G is considered a third generation Factor XI anticoagulant medication in which prior generations have not completely prevented bleeding for patients with anticoagulant disorders. STP122G is a Factor XI inhibitor, a target that is only involved in the endogenous coagulation process that does not impact the coagulation process caused by injury or surgical operation. Therefore, it is considered to have better safety profiles than all previous anticoagulant drugs. There are three types of Factor XI inhibitors currently in the market or clinical trials, including RNA-based treatment, small molecule and monoclonal antibody treatment. As an RNA-based treatment driven by our GalAheadTM delivery system, STP122G targets the hepatocyte to inhibit the production of Factor XI, which could have 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, Sirnaomics' leading RNAi drug candidate, is a siRNA that targets Factor XI. Sirnaomics submitted a U.S. IND for STP122G in March 2023 and launched in April 2023 Phase I clinical trial of STP122G based on its GalNAc-driven Factor XI RNAi therapeutic Program. This Factor XI program is applicable across a broad range of disease indications as an anticoagulant therapeutic, for potential prevention and treatment of stroke after atrial fibrillation, cancer patients after immunotherapy, and improving total knee replacement recovery, etc. It marks the first time Sirnaomics is utilizing its proprietary GalNAc RNAi platform technology, GalAhead™, in one of its siRNA-based candidates and conducting a trial for patients with high unmet need in anticoagulation disorders.
About Sirnaomics Ltd. (Stock Code: 2257)
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 conjugation, the Group has established an enriched drug candidate pipeline. Sirnaomics is currently holding a leadership position on 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 establishment of the Group's manufacturing facility, Sirnaomics currently is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.