Hegia Biopharma Announces First-in-Human Dosing in Phase I Clinical Trial of Kylo-11 in China-VCBeat

Kylo-11 is another significant GalNAc-siRNA product developed by Hygieia using the MVIP platform. It targets a large population of ASCVD patients, aiming to further reduce residual cardiovascular risks and adverse clinical cardiovascular events in this patient group on the basis of existing lipid-lowering therapies. Currently, there are no approved drugs for elevated Lp(a) available in clinical practice, and the clinical development of Kylo-11 will provide more treatment options for ASCVD patients.

Animal experiments show that a single subcutaneous administration of Kylo-11 can effectively reduce serum Lp(a) levels in cynomolgus monkeys for several months, with a certain inhibitory effect on LDL-C. It also demonstrates good safety and tolerability in animal toxicology studies (rats and cynomolgus monkeys). Compared with traditional drug modalities, Kylo-11 delivered via GalNAc has the potential to become the best-in-class therapeutic in this field.

Hygieia has developed multiple siRNA delivery technology platforms with full independent intellectual property rights.

MVIPDelivery PlatformDesigned clinical validation for efficient delivery and effectively preventing exonuclease degradation of the antisense strand end fragments, demonstrating better stability in vivo and no degradation of the antisense strand in plasma.

DDPDelivery PlatformThe second-generation siRNA delivery technology for liver-originated diseases developed by Hygieia can deliver multiple siRNA drugs targeting various comorbid conditions in the complex disease field, enabling the simultaneous delivery of two or more siRNAs. Some pipelines have now advanced to the IND-Enabling Study stage.

NSDP Delivery PlatformThe technology is a technical platform developed by Hygieia for siRNA delivery in neurological diseases, which can target not only the central nervous system (CNS) but also the peripheral nervous system (PNS) and extrahepatic tissues. Currently, multiple pipelines are in the preclinical compound validation stage.

Hygieia, based on the aforementioned siRNA delivery technology platform, focuses on disease areas with urgent clinical needs or no available treatments. Its pipeline covers hepatitis B, NASH/MASH, cardiovascular and metabolic diseases, complement-mediated related diseases, and neurological disorders.