Sino Biopharmaceutical Limited (SBP Group) disclosed final results from the first-in-human Phase I trial of Kylo-11, a novel long-acting small-interfering RNA (siRNA) targeting the LPA gene. The data were delivered as a Late-Breaking Clinical Science presentation at the European Society of Cardiology (ESC) Congress 2026 and published concurrently in The Lancet (Impact Factor 109).
The randomized, double-blind, placebo-controlled study enrolled 70 healthy adults across seven single-ascending-dose cohorts. Participants with baseline lipoprotein(a) [Lp(a)] levels of 75–200 nmol/L received 9 mg, 30 mg, 75 mg, 225 mg, 450 mg or 600 mg, while a separate cohort with baseline Lp(a) >200 nmol/L received 225 mg.
Efficacy data demonstrated profound and durable Lp(a) lowering after a single subcutaneous injection. At Week 48, median percentage reductions from baseline were: • 94.6% at 225 mg (cohort 4) • 95.6% at 225 mg in high-baseline patients (cohort 7) • 96.3% at 450 mg (cohort 5) • 97.0% at 600 mg (cohort 6)
In the high-baseline cohort, median Lp(a) fell from 217.7 nmol/L to 10.5 nmol/L, an absolute decline of 207.7 nmol/L at Week 48. Maximum reduction was reached roughly four weeks post-dose and sustained through one year, supporting the feasibility of an annual dosing regimen.
Safety constituted the primary endpoint. Within 24 weeks post-dose, 37 of 70 subjects reported adverse events, predominantly Grade 1–2 and largely deemed unrelated to Kylo-11. No serious adverse events, injection-site reactions or deaths were recorded, and no participants discontinued treatment.
Kylo-11 employs a non-canonical siRNA architecture with dual GalNAc conjugations on both strands, designed to enhance hepatic uptake and extend duration of action. A Phase II study is ongoing in China and the United States to evaluate efficacy in patients with atherosclerotic cardiovascular disease and elevated Lp(a) and to refine dosing for potential once-yearly administration.
The publication of these Phase I results in a high-impact peer-reviewed journal and their presentation at a premier cardiology forum mark a significant clinical milestone for SBP Group’s cardiometabolic pipeline.