Hygieia Pharmaceuticals Announces First Patient dosed in a US/CN Multi-Center Phase II Clinical Trial Investigating a Long-acting Small Interfering RNA (siRNA) Therapy (Kylo-11) Designed to Lower the Production of Lipoprotein(a) [Lp(a)]

HANGZHOU, China – October [30], 2025 – Hygieia Pharmaceuticals (“Hygieia”, or the “Company”), a clinical-stage biopharmaceutical company today announces that the first patient has been dosed at Peking University First Hospital in an international US/CN multi-center Phase II clinical trial investigating Kylo-11, a small interfering RNA (siRNA) program designed to lower serum lipoprotein(a) [Lp(a)], an important risk factor for cardiovascular diseases. This study will be conducted in both China and the United States.  

High Lp(a) level in the serum is a major, genetically influenced and independent risk factor for cardiovascular diseases, and presents in roughly 20% of the population worldwide^1-2. This condition could double or triple the risk of cardiovascular diseases and is closely associated with stroke and aortic valve stenosis when Lp(a) level is above certain threshold^3-4. To date, no approved drug is available to significantly lower Lp(a) in order to reduce occurrence of cardiovascular events for patients with high risk.

Kylo-11 is an investigational siRNA therapy designed to silence the LPA mRNA, targeting the root cause by inhibiting the synthesis of apolipoprotein(a) (apo[a]), a core component of Lp(a), thereby effectively reducing its circulating level. The Phase I trial in China has demonstrated that Kylo-11 can reduce Lp(a) by >90% in healthy volunteers with elevated Lp(a) level and maintain such reduction for over a year with a single shot at much lower dose than competing programs in clinical development. To our knowledge, Kylo-11 is the first siRNA product globally with such potency that has demonstrated yearly dosing potential in the clinic.

In addition to Kylo-11, Hygieia has 3 other programs currently in the clinic, including an ApoC3 siRNA, a GalNac-conjugated THR-b agonist,and a chronic HBV siRNA product Kylo-04 (HT-101), which has been out-licensed to Hepa Thera, a subsidiary of Fosun Pharma. In July 2025, Kylo-04 (HT-101) was granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA) due to its potentially best-in-class efficacy in reducing HBsAg and, similar to Kylo-11, the longest acting siRNA agent in treating HBV infection. 

References:
[1] Family Heart Foundation. Lipoprotein(a) - Family Heart Foundation. Last accessed Feb. 20, 2025

[2] J Am Coll Cardiol. 2018 Jan 16;71(2):177-192.

[3] Int J Cardiol Heart Vasc. 2024 Oct 30;55:101543.

[4] NIH National Heart, Lung, and Blood Institute. Research Feature – Lipoprotein(a): What to know about elevated levels. Access here: https:// https://www.nhlbi.nih.gov/news/2024/lipoproteina-what-know-about-elevated-levels. Last accessed Feb. 20, 2025.

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About Hygieia Pharmaceuticals

Hygieia Pharmaceuticals is committed to building a delivery technology platform and drug development of siRNA and have established a complete end-to-end siRNA drug development platform from target discovery to clinical Proof of Concept (POC). We have developed multiple siRNA delivery platforms with independent intellectual property rights (IIPR) and have a professional team with rich experience covering the entire lifecycle from early research and development to industrialization.

The MVIP delivery platform has been clinically validated for efficient delivery and effective prevention of exonuclease degradation of antisense end fragments, with better stability in vivo and no antisense chain degradation in plasma. It is the first siRNA delivery platform in China that obtained global patent authorization, and the world's first dual site coupled siRNA delivery technology for hepatic diseases. It has unique stability to prevent siRNA degradation, and its high efficiency, safety, and long-term effectiveness have been verified through multiple clinical pipelines of Hygieia Pharmaceuticals

The DDP delivery platform is the second-generation siRNA delivery platform for hepatic diseases developed by Hygieia Pharmaceuticals, which can simultaneously deliver two or more siRNAs and can be used to develop drugs for complex or refractory diseases mediated by multiple targets and mechanisms. Currently, DDP pipelines have entered the IND Enabling Study phase.

NSDP is another siRNA delivery platform we developed specifically for neurological diseases, able to target not only the central nervous system (CNS) but also the peripheral nervous system (PNS). Currently, multiple NSDP pipelines are in the preclinical compound confirmation stage.

Based on the above siRNA delivery platforms, Hygieia Pharmaceuticals focuses on disease areas that are currently urgently needed or have no available drugs in clinical practice. Our pipelines mainly focus on hepatitis B, NASH/MASH, cardio cerebrovascular and metabolic diseases, complement mediated diseases, nervous system diseases, etc..