TheracosBio’s BRENZAVVY® Matches Dapagliflozin in Chinese Type 2 Diabetes Study

Today, TheracosBio announced the publication of a study in the Journal of Diabetes titled “Comparison of Bexagliflozin with Dapagliflozin as an Adjunct to Metformin in Chinese Patients with Type 2 Diabetes Mellitus: A 24-week Phase 3 Trial.” The study, conducted over 24 weeks and double-blinded, demonstrated that BRENZAVVY® (bexagliflozin) is as effective and safe as dapagliflozin, marketed as Farxiga in the United States, in treating type 2 diabetes mellitus when used alongside metformin.

TheracosBio has disclosed findings from a study showcasing BRENZAVVY, an FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. The drug is designated to complement diet and exercise for enhancing glycemic control in adults diagnosed with type 2 diabetes. However, it’s not advisable for managing type 1 diabetes.

The study, a randomized, double-blind, active-controlled trial, enlisted 406 Chinese patients with type 2 diabetes mellitus. It effectively met its primary objective of establishing BRENZAVVY’s noninferiority concerning HbA1c levels.

When compared to dapagliflozin, BRENZAVVY as an adjunct to metformin yielded promising results:

  • BRENZAVVY treatment demonstrated noninferiority to dapagliflozin, with both arms showing similar reductions in HbA1c levels from baseline to week 24.
  • Significant reductions in fasting plasma glucose were observed in both the BRENZAVVY and dapagliflozin groups.
  • Both treatments contributed to reductions in body mass and systolic blood pressure from baseline to week 24.
  • Safety evaluations indicated comparable incidences of adverse events between the BRENZAVVY and dapagliflozin groups.

Dr. J. Paul Lock, co-author of the study, expressed optimism about the results, emphasizing the clinical equivalence between BRENZAVVY and dapagliflozin. He highlighted the significance for healthcare professionals in selecting effective and affordable treatment options for patients with type 2 diabetes.

The study was conducted collaboratively by clinicians from various Chinese hospitals under the guidance of researchers associated with TheracosBio and Newsoara Biopharma Co., Ltd., the licensee of bexagliflozin in China.

Brian Connelly, CEO of TheracosBio, stressed the importance of providing affordable treatment options for diabetes management, underscoring BRENZAVVY’s efficacy and safety demonstrated in the head-to-head study.

In the United States, BRENZAVVY is offered at a straightforward, low cash-pay price through a network of pharmacies, aiming to make it accessible to uninsured patients and to circumvent insurance-related barriers.

BRENZAVVY is indicated for adults with type 2 diabetes as an adjunct to diet and exercise. It has shown significant reductions in hemoglobin A1c and fasting blood sugar levels in phase 3 clinical trials, either as a monotherapy or in combination with other diabetes medications. Although not approved for weight or blood pressure reduction, modest decreases in both have been observed.

BRENZAVVY is available as 20 mg oral tablets recommended for once-daily consumption, preferably in the morning with or without food. It’s contraindicated in individuals hypersensitive to bexagliflozin or any other component in the tablet.

Common side effects of BRENZAVVY include female genital mycotic infections, urinary tract infections, and changes in urination, with the possibility of more severe side effects.

BRENZAVVY treatment can commence in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or greater. Notably, it’s been shown effective for glycemic control in adults with type 2 diabetes and stage 3 chronic kidney disease, a distinction achieved in a randomized, controlled clinical trial.

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