02 June 2023 | Friday | News
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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.
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