BRENZAVVY proves effective in TheracosBio’s Phase 3 Type 2 diabetes study

TheracosBio announced the publication of a 24-week randomized, double-blind, placebo-controlled trial, proving Bexagliflozin’s effectiveness as an adjunct to Metformin for treating adults with type 2 diabetes. The Phase 3 study, published in “Diabetes, Obesity and Metabolism,” highlights the positive impact of BRENZAVVY (bexagliflozin), 20 mg, in improving glycemic control and reducing systolic blood pressure levels.

BRENZAVVY Shows Improvement in Glycemic Control

The study assessed BRENZAVVY’s safety and effectiveness in comparison to a placebo in adults with type 2 diabetes. The results revealed that BRENZAVVY treatment decreased systolic blood pressure levels and fasting plasma glucose levels, in addition to enhancing glycemic control in patients with type 2 diabetes. The medication is now indicated for improving glycemic control in adults with type 2 diabetes, including chronic kidney disease stage 3 patients.

“These data illustrate the potential benefits of BRENZAVVY for adults with type 2 diabetes,” said Brian Connelly, President and CEO of TheracosBio. “These data strengthen the evidence that BRENZAVVY supports improvements in systolic blood pressure, which is beneficial for patients with kidney disease. BRENZAVVY represents an important addition to the treatment options for type 2 diabetes.”

Study Details and Key Findings

The trial enrolled 317 adults and included an open-label group of 34 patients with severe diabetes. The primary endpoint was the change in HbA1c from baseline to week 24. Key findings include:

• 1.09% reduction of HbA1c from baseline with a placebo-adjusted treatment effect of −0.53%.
• A decrease in systolic blood pressure levels by 5.03 mm Hg with a placebo-adjusted reduction of 7.07 mm Hg.
• A decrease in fasting plasma glucose levels by 45.2 mg dL-1 with a placebo-adjusted reduction of 24.3 mg dL-1.

BRENZAVVY is available in 20 mg oral tablets and is recommended to be taken once daily. Certain side effects and contraindications are associated with the medication.

Conclusion

The publication of the BRENZAVVY study emphasizes the promising role of the medication as a therapeutic option for type 2 diabetes patients, particularly those with stage 3 chronic kidney disease. The results reinforce its potential for improving glycemic control, a critical factor in managing diabetes.