SRSD216 Demonstrates Sustained Lp(a) Reduction and Favorable Safety Profile in Phase 1 Trial
March 31st, 2026
Data presented at the American College of Cardiology (ACC) Annual Session in New Orleans highlight substantial and durable reductions in lipoprotein(a) across multiple dose cohorts.
San Diego, US and Shanghai, China – March 31, 2026 – Sirius Therapeutics today announced positive new data from its ongoing clinical trial of SRSD216, a novel drug candidate designed to lower lipoprotein(a) (Lp(a)). The findings, presented this past weekend at the American College of Cardiology (ACC) Annual Scientific Session in New Orleans, reinforce the candidate's best-in-class potential, demonstrating a favorable safety profile alongside substantial and sustained reductions in Lp(a) levels.
The data showed that SRSD216 produced robust, dose-dependent reductions in Lp(a). Maximal median percent changes from baseline were:
● -87.2% in the 100mg dose cohort
● -94.5% in the 300mg dose cohort
● -94.7% in the 600mg dose cohort
In comparison, the placebo group saw a median change of -0.1%.
Furthermore, the Lp(a)-lowering effect proved durable, with reductions persisting throughout the current observation period of seven months. At 7 months, the % inhibition of Lp(a) levels remained greater than 90% in the 300mg and 600mg groups.
SRSD216 continued to exhibit a favorable safety and tolerability profile. Notably, there were no serious adverse events (SAEs), no deaths, and no drug discontinuations reported during the trial.
"We are highly encouraged by these results, which underscore SRSD216's potential to offer patients a potent, durable, and well-tolerated option for reducing Lp(a), a key risk factor for cardiovascular disease," said Patrick Yue, Chief Medical Officer at Sirius Therapeutics. "The combination of deep, sustained reductions with a clean safety profile supports our confidence as we advance into the next phase of development."
The company initiated a Phase 2 clinical trial, with the first patient dosed in December 2025 in a multi-regional study, which is being conducted across sites in China and the United States. The company expects to begin reading out interim data from the Phase 2 trial in the second half of this year.
About ASCVD and hyperlipoproteinemia(a)
Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death worldwide. Dyslipidemia is regarded as a key contributor to the development of ASCVD. While low-density lipoprotein cholesterol (LDL-c) has been considered the primary lipid indicator and target for intervention for decades, numerous studies have identified lipoprotein(a) [Lp(a)] as an independent risk factor for ASCVD. Moreover, Lp(a) is not modified by age, diet, or exercise and currently available pharmacotherapies for dyslipidemia have only modest effects on Lp(a), highlighting a significant clinical unmet need for agents that directly target Lp(a).
About SRSD216
SRSD216 is a double-stranded small interfering ribonucleic acid (siRNA) that specifically modulates the LPA gene, decreasing hepatic Apo(a) production and reducing circulating Lp(a) levels. In pre-clinical studies, analysis has demonstrated high target specificity and clean safety profile. In a Phase 1 study, 3-month interim readouts indicated dose-dependent activity, up to 95% reduction in Lp(a) levels, with reductions persisting for at least 12 weeks and no meaningful safety findings reported after a single subcutaneous dose. Subjects remain in the follow-up period, with data collection ongoing.
About Sirius Therapeutics
Sirius is a global, clinical-stage biotech company developing innovative siRNA therapies focusing on the treatment of chronic diseases. The Company's pipeline is centered around three key franchises with mega blockbuster potential: coagulation disorders, cardiometabolic diseases, and obesity. Sirius' most advanced investigational programs include SRSD107, a FXI inhibitor targeting the anticoagulation market, SRSD216, an inhibitor of Lp(a) synthesis intended to address atherosclerotic cardiovascular disease, and SRSD384, an INHBE inhibitor for managing obesity.
Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovation center in the United States and a translational medicine center in China. Sirius has raised nearly US$150 million in funding to date from OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, and BioTrack Capital.
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