On April 8 (local time), Kylo-11 (LPA-siRNA), independently developed by Hygieia, a wholly-owned subsidiary of Sino Biopharmaceutical (1177.HK), achieved the enrollment of the first US patient in the United States for its Phase II clinical trial in patients with atherosclerotic cardiovascular diease (ASCVD) and elevated lipoprotein (a) [Lp(a)]. In October 2025, the China portion of this clinical trial had completed the enrollment of the first Chinese patient. Currently, there are no approved therapeutic drugs targeting elevated Lp(a) on the global market. The development of Kylo-11 will bring more treatment options to patients. 

 

This study (Kylo-11-II-C01) is a China-US Phase II clinical study of Kylo-11 for the treatment of patients with ASCVD and elevated Lp(a), aiming to evaluate the efficacy and safety of Kylo-11 with semi-annual or annual dosing in this patient population. At the 2025 American Heart Association (AHA) Scientific Sessions, the preliminary blinded data analysis results of the Phase I clinical trial of Kylo-11 were announced in an oral presentation^[1]:

 

● After a single dose of Kylo-11, the reduction in serum Lp(a) levels was significant and durable

 

- At 24 weeks, the reductions in cohorts 1-7 (9 mg, 30 mg, 75 mg, 225 mg, 450 mg, 600 mg, and 225 mg) were maintained at 83.5%, 88.9%, 95.2%, 96.7%, 97.2%, 97.4%, and 98.4%, respectively. 

 

- In subjects with baseline Lp(a) of 75-200 nmol/L, the reduction in Lp(a) in the 30 mg group (cohort 2) was still maintained at 77.6% at week 48, the reduction in the 75 mg group (cohort 3) was maintained at 88.8% at week 44, and the reduction in the 225 mg group (cohort 4) was maintained at 96.7% at week 40. 

 

- In subjects with baseline Lp(a) >200 nmol/L who received a single 225 mg dose, the reduction in Lp(a) was still maintained at 98.4% at week 28. 

 

- In dose groups ≥30 mg, subjects' serum Lp(a) levels dropped below 75 nmol/L from week 4 post-dosing and remained below this level throughout the follow-up period. 

 

● Good safety and tolerability

 

- Most treatment-emergent adverse events were Grade 1-2 and not related to the study drug. No serious adverse events, adverse events leading to study discontinuation, or injection site adverse reactions occurred during the trial. 

 

ASCVD is a group of diseases caused by atherosclerosis, encompassing coronary heart disease, cerebrovascular disorder, and peripheral artery disease, and has become a leading cause of death worldwide. Lipoprotein(a) [Lp(a)], a genetically determined, cholesterol-rich particle, has been established as an independent risk factor for ASCVD^[2]. Lp(a) not only has pro-atherogenic properties similar to low-density lipoprotein (LDL), but its unique apolipoprotein(a) structure may also promote inflammation and thrombosis^[3]. Currently, there are no effective treatments specifically for lowering Lp(a) levels worldwide, and no specific drugs targeting Lp(a) have been approved for marketing, leaving a significant unmet clinical need. 

 

Kylo-11 is a siRNA drug targeting the LPA gene, developed based on Hygieia's MVIP delivery platform, with BIC potential. This technology platform is the first siRNA delivery technology platform in China to receive global patent authorization. Its world-first dual-conjugate siRNA delivery technology targeting liver-derived diseases can effectively prevent exonuclease degradation of the antisense strand's terminal fragments and reduce antisense strand degradation in plasma, achieving efficient delivery and long-term stability, and granting Kylo-11 ultra-long-acting potential for once-yearly administration. 

 

The Phase II clinical trial of Kylo-11 is currently advancing patient enrollment simultaneously in China and the US. Sino Biopharmaceutical will strive to bring a new treatment option to patients worldwide as soon as possible, contributing to technological breakthroughs in the field of cardiovascular disorder treatment. 

 

References:

 

[1] Xiaolin Du, et al.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.2025 AHA.#4390197.

[2] PAMIR N, FAZIO S. Lipoprotein (a)gets worse [J].Circ Res,2020,126(10): 1360-1362.

[3] Wu D R, Lin X K. The role of lipoprotein(a) in atherosclerotic cardiovascular disease and new progress in its treatment[J]. Journal of Frontiers of Medicine, 2026, 16(08):38-41+45. 

 

Declaration:

 

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

 

Forward-Looking Statements:

 

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expected clinical benefits and advantages, commercialization prospects, the possibility of clinical benefit to patients, and potential commercial opportunities for [Kylo-11]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.