Sirnaomics has concluded the second cohort of its Phase I clinical trial of small interfering RNA (siRNA) candidate, STP122G, for anticoagulant therapeutics.
An anticoagulation agent, the GalNAc-based RNAi therapy targets Factor XI and aims to provide a safer alternative to current treatments.
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The second cohort consisted of eight healthy participants who received a 50mg dose of STP122G through subcutaneous administration.
Over a 140-day follow-up period, no dose-limiting toxicities or serious adverse events were reported.
Due to the observed dose-dependent target silencing activity, the study will advance to the next dosing cohort with up to a total of five escalating dosing cohorts planned.
The multi-centre, randomised, double-blind Phase I trial is assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of STP122G.
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By GlobalDataIt will compare the effects of five escalating doses (25mg, 50mg, 100mg, 200mg, and 400mg) to determine the optimal dose for future research.
The company aims to recruit a total of 40 participants across the five dosing cohorts.
Factor XI is a crucial enzyme in the blood clotting cascade, and its inhibition could reduce bleeding risks for patients with anticoagulant disorders.
The Phase I trial commenced in April 2023 with the second cohort launched in January this year.
Sirnaomics CEO, executive director, president and founder Dr Patrick Lu said: “STP122G is the first candidate based on the group’s GalAhead mxRNA technology targeting Factor XI for anticoagulation application.
“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 dose-dependent Factor XI silencing activities.”
Recently, the company concluded the Phase I clinical trial of a siRNA therapeutic candidate, STP707, to treat patients with pancreatic cancer.
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