Jan 02,2019
Recently, the Center for Drug Evaluation, National Medical Products Administration completed the technical review on the application for a clinical trial of a new oligonucleotide therapeutics for the treatment of type 2 diabetes submitted by Suzhou Ribo Life Science Co., Ltd., and issued the Notice for Clinical Trial. This marks another important milestone for Ribo after the oligonucleotide therapeutics for the treatment of optic neuropathy were approved to enter phase II/III pivotal clinical trials in 2015. It is also the second oligonucleotide-based drug in China to enter Phase II clinical trials.
This oligonucleotide therapeutics belongs to Class I innovative drugs not marketed in China or abroad. Unlike the mechanism of action of other hypoglycemic agents, this product blocks the function of glucagon by decreasing the expression of glucagon receptors (GCGR) in the liver and adipose tissue, thereby reducing hepatic glucose conversion and output while achieving the purpose of lowering blood glucose. This product also helps to increase GLP-1 expression levels in vivo and up-regulate insulin secretion by improving pancreatic β-cell function. The dual mechanism of this product provides multiple benefits for patients with severe diabetes or poor glycemic control with existing therapies.
This new anti-diabetic oligonucleotide therapeutics is a product introduced by Ribo from the world's leading oligonucleotide pharmaceutical company, Ionis, in the United States. The clinical trial on ISIS449884 has been completed overseas and it showed that once-weekly dosing not only exhibited good safety and good tolerability, but also achieved significant efficacy in reducing HbA1c levels by at least 1% in more than half of patients at lower doses. Based on the available and informative overseas clinical study data, the Center for Drug Evaluation agreed that the product could enter Phase II clinical study in China to explore appropriate drug regimens for Chinese patients with type 2 diabetes. In addition, it will address the unmet clinical needs of patients with type 2 diabetes who had poor responses to existing treatment.
2018 was a year of milestones in the development of oligonucleotide therapeutics: the first RNAi drug Patisiran and the new ASO Tegsedi were approved for marketing in the United States. So far, eight oligonucleotide therapeutics have been approved worldwide. This shows that oligonucleotide therapeutics, representing the third wave of modern pharmaceutical development following monoclonal antibodies, are entering an exciting explosive stage of development with their revolutionary advantages. As the pioneer and leader of China's siRNA pharmaceutical industry, Ribo has a spontaneous burst-out driven by deep accumulation. Furthermore, it has steadily moved from the accumulation period of technological innovation to the industrialization stage of innovative varieties.
