Hygieia Pharmaceuticals’s Kylo-11 significantly reduces Lp(a) level with once-a-year dosing in Phase I study for people with Hyperlipidemia

HANGZHOU, China — Hygieia Pharmaceuticals Co., Ltd. (hereinafter referred to as “Hygieia”) recently announced that it has obtained promising results from interim analysis of a Phase I clinical trial for Kylo-11, an LPA-targeted small interfering RNA to reduce the expression of lipoprotein(a) in healthy volunteers with Hyperlipidemia.

The study (NCT06363851/CTR20241810) is a placebo-controlled, double-blind, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Kylo-11 in healthy volunteers with elevated lipoprotein(a) [Lp(a)]. All data collected so far support continuous exploration of Kylo-11 in atherosclerotic cardiovascular disease (ASCVD) patients with abnormal Lp(a) levels.

Though this is an early investigation, Kylo-11 has showed great potency in lowering Lp(a) with long-lasting effect. A single subcutaneous injection of Kylo-11 is capable of achieving >95% Lp(a) reduction, and the therapeutic effect is expected to last for more than 12 months. According to publicly available data, Kylo-11 is the only siRNA in its class that can achieve such long-lasting effect with relatively low dose. Moreover, Kylo-11 exhibited favorable safety profile during the trial. We are fully confident in progressing Kylo-11 to a global multi-center Phase II clinical trial that is coming soon.

It is worth mentioning that Kylo-04/HT-101 (collaborated with Fosun Pharma), the first siRNA product developed by Hygieia, has been recently awarded Breakthrough Designation in HBV treatment by China’s National Medical Products Administration (NMPA) due to its best-in-class potency in HBsAg reduction (＞3log) and long-lasting effect. Together with Kylo-04, Kylo-11 once again demonstrates the unique capabilities of Hygieia’s best-in-class, proprietary MVIP platform for efficient hepatic delivery of siRNA.

Hygieia is redefining the future of chronic disease treatment by forging a new class of durable and potent siRNA therapeutics for patients.

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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..