TheracosBio has recently published a study titled “Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: a 24-week, randomized, double-blind, active-controlled, phase 3 trial” in the Journal of Diabetes. This study showcases the noninferiority of BRENZAVVY® (bexagliflozin) to dapagliflozin, known as Farxiga in the United States, among patients with type 2 diabetes mellitus.
BRENZAVVY, an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, serves as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes. Notably, BRENZAVVY is not advisable for individuals with type 1 diabetes mellitus.
Enrolling 406 patients across multiple sites in China, the randomized, double-blind, active-controlled trial achieved its primary endpoint of demonstrating noninferiority in HbA1c levels. Here are some key findings from the study:
- BRENZAVVY treatment proved noninferior to dapagliflozin, showcasing a change in HbA1c from baseline to week 24 of -1.08% in the BRENZAVVY arm and -1.10% in the dapagliflozin arm.
- Significant reductions in fasting plasma glucose were observed in both the BRENZAVVY arm (-1.95 mmol L-1 (-35.1 mg dL-1)) and the dapagliflozin arm (-1.87 mmol L-1 (-33.17 mg dL-1)) from baseline to week 24.
- Both BRENZAVVY and dapagliflozin treatments resulted in decreased body mass in patients from baseline to week 24. The change from baseline body mass was -2.52 kg (5.56 lb) in the BRENZAVVY arm and -2.2 kg (4.89 lb) in the dapagliflozin arm.
- Systolic blood pressure also exhibited reductions from baseline to week 24 in patients treated with either BRENZAVVY or dapagliflozin, with the BRENZAVVY arm showing a change of -6.4 mm Hg and the dapagliflozin arm showing a change of -6.3 mm Hg.
The study also assessed safety measures, revealing a comparable incidence of adverse events between the BRENZAVVY and dapagliflozin arms.
J. Paul Lock, MD, co-author of the publication, medical monitor at TheracosBio, and endocrinologist at MetroWest Medical Center, Framingham, MA, commented on the study’s implications, highlighting that BRENZAVVY’s clinical activity mirrors the metabolic effects and safety of dapagliflozin. He emphasized the significance of BRENZAVVY as an effective and affordable alternative for diabetes management, particularly in real-world clinical settings.
Conducted by clinicians from various Chinese hospitals under the guidance of researchers affiliated with TheracosBio and Newsoara Biopharma Co., Ltd., the study underscores the importance of accessible treatment options for patients with diabetes, such as BRENZAVVY.
TheracosBio CEO Brian Connelly reiterated the importance of providing affordable treatment options for diabetes control. He emphasized that BRENZAVVY-treated patients with type 2 diabetes experience metabolic outcomes similar to those receiving other SGLT2 inhibitors.
In the United States, BRENZAVVY is available at a straightforward, low cash-pay price through a network of pharmacies, making it accessible to uninsured individuals and simplifying the process for insured patients.
BRENZAVVY, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, has shown significant reductions in hemoglobin A1c and fasting blood sugar in Phase 3 clinical studies. It is available as 20 mg oral tablets recommended for once-daily administration, preferably in the morning with or without food.
For more information about BRENZAVVY and its full prescribing details, visit https://www.brenzavvy.com. Adverse reactions can be reported to TheracosBio at 1-855-BRENZAVVY (1-855-273-6928), the FDA at 1-800-FDA-1088, or through www.fda.gov/medwatch.
