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On 27th April, SynerK, an innovative biopharmaceutical company focusing on developing RNA-targeted therapeutics, announced that its Phase I clinical trial of the first small interfering RNA (siRNA) product under research has been completed with the first subject enrolled for dosing. Public data shows that this is the first domestic siRNA candidate drug against a specific target, which is involved in the clinical administration and treatment phase in subjects. SynerK owns the completely independent intellectual property right.
The siRNA candidate is developed based on SynerK's patent-pending, internationally leading GalNAc liver-targeted delivery platform, which is capable of safely and efficiently delivering siRNAs to liver cells, utilizing the RNA interference to intervene in the synthesis of liver-targeted proteins directly at the mRNA level to achieve therapeutic goals. Compared to earlier developed siRNA drugs, this siRNA candidate is more stable in vivo while maintaining excellent activity and drug safety.
This Phase I, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and tolerance of subjects injected with the drug and to explore the pharmacokinetics and preliminary efficacy. Dr. Lan Tao, CEO of SynerK, said that novel nucleic acid therapeutics represented by siRNA drugs currently possess a huge market space, with many industry players, but most of them are still focused on the preclinical stage. "The achievement of safe administration to the first subject in this study represents that this new siRNA drug has taken the lead in the human trial stage, which is an important milestone for SynerK on the road to exploring siRNA therapy."
This milestone was accomplished thanks to the SynerK team's decades of technical accumulation and superior execution capabilities in the field of nucleic acid therapeutics. "For the time being, the SynerK team is probably the only team in China with complete experience in siRNA drug launch, with first-hand experience in siRNA design, synthesis, and screening, CMC, preclinical studies, and clinical trials. We will use this siRNA product as a breakthrough to lay the foundation for subsequent development of innovative therapies for other disease targets." Dr. Lan Tao, CEO of SynerK, said, " SynerK has several siRNA-targeted drugs in development covering cardiovascular/metabolic diseases, liver diseases, infectious diseases, complement, coagulation-related diseases, and CNS diseases. Our company has a unique platform of innovative delivery technologies targeting the liver and extrahepatic organs. We currently advance several preclinical R&D projects and expect more breakthrough small nucleic acid-based drugs to enter the clinical stage in the future."
Dr. Weiwen Jian, Co-Founder and Head of Research of SynerK, said, "Based on decades of experience in nucleic acid pharmaceuticals and extensive in-vitro and in-vivo experimental screening, SynerK's team has carefully designed this siRNA drug candidate, which has applied for patents around the world. In animal model experiments, the efficacy of this drug candidate, including the indicators of biomarker changes and duration, has reached an internationally advanced level. In preclinical trials, it has demonstrated a similar or better safety than other marketed siRNA drugs.
"Compared to small molecules and antibody-based drugs, siRNA drugs have a longer duration of efficacy and are administered less frequently, which can significantly improve patient's adherence to medication." Dr. Xing Gang, Head of Clinical Research and Development of SynerK, said, "This Phase I clinical trial will provide us with sufficient safety, tolerance, and PK/PD data to support future mid- to late-stage clinical trials. We will advance the clinical trial as fast as possible to provide patients with a new treatment as soon as possible."