Suzhou Ribo Life Science Co., Ltd. (Ribo) has announced the successful completion of two phase II clinical trials of ISIS 449884, an antisense oligonucleotide（ASO）drug for treatment of Type 2 Diabetes Mellitus (T2DM).
Those studies are the first two clinical studies for ISIS 449884 in China for evaluation of its effects in patients with type 2 diabetes, who were either treatment-näive undergoing life-style intervention or on background treatment with metformin. RBGR1201 was "A Multicenter, Randomized, Double-blind, Placebo-Controlled, 2: 1 Parallel-Group Phase II Clinical Study to Evaluate the Efficacy and Safety of ISIS 449884 Injection Monotherapy in Patients with Type 2 Diabetes Mellitus with Poorly Controlled Blood Glucose Following Diet and Exercise Interventions", and a total of 57 T2DM patients were recruited from 20 study sites. RBGR1202 was " A Multicenter, Randomized, Double-blind, Placebo-Controlled, 2: 1 Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of ISIS 449884 Injection in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Controlled Inadequately by Metformin Monotherapy." 90 T2DM patients were recruited from 26 study sites.
The results of both clinical studies showed that ISIS 449884 significantly reduced HbA1c level compared to placebo, and met the primary endpoint. No increased incidence of hypoglycemic or serious hypoglycemic events was associated with the drug treatment. Noteworthy, especially on top of metformin as a background treatment, ISIS 449884 showed even stronger clinically meaningful HbA1c reducing ability as compared to its effects in patients on life-style intervention. The PK profiles were similar to those seen in the previous clinical trials of ISIS 449884. Except for several cases of reversible mild liver enzyme elevations, ISIS 449884 was in general safe and tolerated.
About ISIS 449884
ISIS 449884 is a 2 '-O- (2-methoxyethyl) (2' -MOE) antisense inhibitor targeting glucagon receptor (GCGR). Ribo obtained the exclusive R&D and commercialization rights of ISIS 449884 in China from Ionis Pharmaceuticals Inc. (Ionis), a global leader in antisense drug development. With a different mechanism of action from other hypoglycemic agents, ISIS 449884 blocks the function of glucagon by reducing the expression of glucagon receptors in liver and adipose tissue, thus reducing the conversion and output of glycogen and achieving the purpose of lowering blood glucose. ISIS 449884 is expected to provide potential benefit for patients with severe diabetes or poor glycemic control with existing treatments.