TheracosBio has reported data from a Phase III clinical trial where BRENZAVVY (bexagliflozin) as an adjunct to metformin in managing type 2 diabetes (T2D) mellitus in Chinese patients, met the primary endpoint.
BRENZAVVY is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the US Food and Drug Administration (FDA).
The oral tablet is designed to improve glycemic control in adults with T2D when used adjunct to diet and exercise.
The 24-week, randomised, double-blind, active-controlled trial analysed the efficacy and safety of bexagliflozin against dapagliflozin, both in conjunction with metformin.
It enrolled 406 patients across various sites in China.
The trial met the primary endpoint indicating BRENZAVVY’s noninferiority to dapagliflozin in HbA1c levels.
A -1.08% change in HbA1c from baseline to week 24 was seen in the BRENZAVVY arm, compared to a -1.10% change in the dapagliflozin arm.
Significant improvements were observed in fasting plasma glucose levels with the BRENZAVVY arm showing a reduction of -1.95 mmol L-1 versus -1.87 mmol L-1 in the dapagliflozin group.
Furthermore, patients treated with BRENZAVVY experienced reductions in body mass and systolic blood pressure from baseline to week 24.
The safety profile of BRENZAVVY was in line with dapagliflozin, with a similar number of patients experiencing adverse events in both treatment groups.
TheracosBio CEO Brian Connelly said: “It is important for patients with diabetes to have affordable treatment options such as BRENZAVVY to control their disease.
“We do not think that patients should have to compromise on efficacy or safety when they receive a more affordable option.
“This head-to-head study offers additional evidence that BRENZAVVY-treated patients with type 2 diabetes see metabolic outcomes similar to those with other SGLT2 inhibitors.”
In August last year, the company reported data from a Phase III of BRENZAVVY as an adjunct to metformin versus placebo in T2D mellitus patients.
