Kylo-11 / Kylonova Biopharma, Hygieia Pharmaceuticals - LARVOL DELTA

Extremely Long Duration Lp(a) Reduction Following a Single Dose of Kylo-11: Final Data from a First-in-Human Study (ESC 2026) - No abstract available

First-in-human • Late-breaking abstract • P1 data • Cardiovascular

Deep and durable lipoprotein(a) lowering: Kylo-11 advances RNA interference therapeutics. (PubMed, Lancet) - No abstract available

Journal

Safety and lipoprotein(a)-lowering effects of Kylo-11, a non-canonical, long-duration small interfering RNA targeting lipoprotein(a): a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial. (PubMed, Lancet) - P1 | "A single dose of Kylo-11 was well tolerated, and at doses of 225 mg or higher, durably reduced serum lipoprotein(a) concentrations up to 48 weeks."

First-in-human • Journal • P1 data • Atherosclerosis • Cardiovascular • Dyslipidemia

Kylo-11-I-C01: Single-ascending Dose Study of Kylo-11 in Healthy Subjects (clinicaltrials.gov) - P1 | N=71 | Completed | Sponsor: Kylonova (Xiamen) Biopharma co., LTD. | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Cardiovascular

Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a) (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

New P2 trial • Atherosclerosis • Cardiovascular

Dose-Dependent and Sustained Reduction in Lipoprotein(a) levels after single-dose of Kylo-11, a LPA-targeted Small Interfering RNA, in Healthy Volunteers: A First-in-Human Phase I Study (AHA 2025) - P1 | "Kylo-11 was well tolerated in Chinese healthy volunteers. Higher doses produced greater and more sustained reductions in serum Lp(a) levels over 48 weeks of follow-up. These findings support further investigation of Kylo-11 in patients with elevated Lp(a), with potential for administration once every 6 months or annually."

Clinical • First-in-human • P1 data • Atherosclerosis • Cardiovascular

Kylo-11-I-C01: Single-ascending Dose Study of Kylo-11 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Kylonova (Xiamen) Biopharma co., LTD. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular

Kylo-11-I-C01: Single-ascending Dose Study of Kylo-11 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Kylonova (Xiamen) Biopharma co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular

Kylo-11-I-C01: Single-ascending Dose Study of Kylo-11 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

New P1 trial • Cardiovascular