Jul 12,2018
Recently, Center for Drug Evaluation, National Medical Products Administration officially accepted the clinical trial application of imported drug ISIS449884 Injection submitted by Suzhou Ribo Life Science Co. Ltd.,. This product belongs to Class 1 innovative drug not marketed in China or abroad, and the proposed indication is type 2 diabetes.
Unlike currently marketed glucose-lowering products, ISIS449884 has a dual glucose-lowering effect by inhibiting glucagon: it reduces hepatic glucose production and effectively regulates insulin secretion by improving pancreatic β-cell function. The glucagon/insulin imbalance results in enhanced glucagon action for patients with diabetes. ISIS449884 blocks glucagon function by decreasing the expression of the glucagon receptor (GCGR) in the liver and adipose tissue.
ISIS449884 is a product introduced by Suzhou Ribo from Ionis, a global leader in oligonucleotide therapeutics development. Completed clinical trials have shown that once-weekly dosing exhibited good safety and tolerability and achieved significant efficacy in reducing HbA1c levels by at least 1% in more than half of patients at lower doses.
Ribo plans to initiate a phase II clinical study as early as possible in China, further optimize the dosing frequency and dose in the type II diabetic population, explore a dosing regimen suitable for Chinese patients, and address the unmet clinical needs of type II diabetic patients with poor response to existing treatments.
The study on ISIS449884 will be the second clinical trial of oligonucleotide therapeutics initiated by Suzhou Ribo in China. In November 2017, Suzhou Ribo announced the completion of the administration in the first Chinese subject in a global pivotal study QPI-1007 on its optic nerve protection, which is currently progressing smoothly.
