Biopharmaceutical company Sirnaomics has completed the investigational new drug (IND)-enabling studies of the safety and efficacy of STP125G, a small interfering RNA (siRNA) therapeutic that targets apolipoprotein C3 (ApoC3).
The studies, conducted on non-human primates (NHP), have reported positive results in safety and efficacy, paving the way for a Phase I clinical trial submission to the US Food and Drug Administration (FDA) for cardiovascular disease indications.
The efficacy of STP125G was evaluated in a dose-dependent manner, with the highest silencing activity observed at a 10mg/kg dose, which was sustained over 13 weeks.
In terms of safety, the therapy demonstrated a strong profile, even at high doses of up to 250mg/kg in the NHP model.
Said to be a potent modulator of several established CVD risk factors, ApoC3 is found on chylomicrons, LDL, VLDL, and HDL particles.
Based on Sirnaomics’ GalAhead mxRNA technology, STP125G aims to silence the ApoC3 mRNA, thereby reducing the risk of cardiovascular events.
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Sirnaomics founder and CEO Dr Patrick Lu said: “STP125G is the second drug candidate based on our GalAhead mxRNA technology that has shown excellent safety and potent efficacy results with the NHP models. Its long-lasting silencing activity against ApoC3 may provide better therapeutic benefit to patients suffering cardiovascular conditions, than those of antisense and other siRNA drugs.
“Those data readouts further validated STP125G as a novel siRNA therapeutic candidate for the treatment of hypertriglyceridemia and other cardiovascular diseases, using our proprietary GalAhead-based delivery technology.”
Last week, Sirnaomics concluded the second cohort of its Phase I clinical trial of siRNA candidate STP122G for anticoagulant therapeutics.
The GalNAc-based RNAi therapy targets Factor XI and aims to provide a safer alternative to current treatments.
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
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- Source: https://www.clinicaltrialsarena.com/news/sirnaomics-trials-sirna-therapy/