RiboLife Announces Positive Top-Line Results from Two Phase 2 Trials of ASO Drug ISIS449884 in Type 2 Diabetes

On February 22, Ribo Life Science announced that the two Phase II clinical trials of the antisense oligonucleotide (ASO) drug ISIS449884 injection for type 2 diabetes were successfully completed. Both clinical studies met their primary endpoints.

According to the introduction on Ribo Life Science's official website, antisense oligonucleotides are single-stranded oligonucleotide molecules. After entering cells, they bind to target mRNA through sequence complementarity under the action of ribonuclease H1 (RNase H1), causing degradation of the mRNA and thereby inhibiting protein expression; or they regulate gene transcription through steric hindrance effects, achieving selective splicing of RNA precursors, modulating protein expression and function, playing a role in treating diseases.

ISIS449884, introduced from Ionis Pharmaceuticals, is exclusively licensed to Ribo Life Science for research, development, and commercialization in China. According to reports, this is a second-generation 2′-O-(2-methoxyethyl) (2′-MOE) antisense oligonucleotide inhibitor targeting the glucagon receptor (GCGR). Unlike other hypoglycemic drugs, ISIS449884 blocks the function of glucagon by reducing the expression of glucagon receptors in the liver and adipose tissue, thereby decreasing hepatic glucose production and output to lower blood glucose levels. The product also has the ability to increase GLP-1 expression and improve pancreatic β-cell function, offering potential dual benefits for patients with severe diabetes or those whose blood glucose levels are poorly controlled by existing treatments.

This time, both of the two clinical trials of ISIS449884 have reached the clinical study endpoints. Among them, the RBGR1201 trial is "A multicenter Phase 2 clinical study to evaluate the efficacy and safety of ISIS449884 injection as monotherapy in patients with type 2 diabetes whose blood glucose control is poor after dietary and exercise interventions." A total of 20 research centers participated in patient recruitment, enrolling 57 patients with type 2 diabetes; the RBGR1202 trial is "A multicenter Phase 2 clinical study to evaluate the efficacy and safety of ISIS449884 injection combined with metformin in patients with type 2 diabetes whose blood glucose control is inadequate with metformin alone." A total of 26 centers participated in patient recruitment, enrolling 90 patients with type 2 diabetes.

Results from two clinical studies both showed that the ISIS449884 treatment group significantly reduced glycated hemoglobin (HbA1c) levels compared to the placebo group, achieving the primary endpoint without increasing the incidence of hypoglycemic events or severe hypoglycemic events. Particularly when metformin was used as a background medication, the candidate drug demonstrated a stronger clinically significant ability to lower HbA1c. Additionally, apart from reversible mild elevation of liver enzymes observed in some participants, the candidate drug exhibited good safety and tolerability.

Public information shows that Ribo Life Science was founded in 2007. It is committed to the research and development of innovative small nucleic acid drugs, as well as the development and commercialization of clinical projects worldwide. Through independent innovation and international cooperation, Ribo Life Science has developed a rich pipeline of small nucleic acid drug candidates, covering various therapeutic areas such as ophthalmic diseases, central nervous system disorders, cancer, liver diseases, and antiviral treatments.

We look forward to the smooth progress of Ribo Life Science's antisense oligonucleotide drug in subsequent clinical development, and hope it can bring more treatment options to patients with type 2 diabetes as soon as possible.

References:

[1] Ribo Life Science Successfully Completes Two Phase II Clinical Trials of Antisense Nucleic Acid Drug for Type 2 Diabetes. Retrieved Feb 22, 2022. From https://mp.weixin.qq.com/s/rfHc2lBb2uDkN-Bao_qCJw

[2] Ribo Life Science Official Website. From https://www.ribolia.com/about-ribo

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