Better Therapeutics (NSDQ:BTTX) announced that it completed patient enrollment in a study of its digital therapeutic in treating diabetes.
San Francisco-based Better Therapeutics’ BT-001 prescription digital therapeutic delivers a novel cognitive-behavioral therapy to patients with uncontrolled type 2 diabetes.
According to a news release, the trial for BT-001 exceeded its enrollment target, bringing in 662 patients from centers across California, Illinois, Florida, Georgia, New York and Texas. Positive study results may support regulatory submission to the FDA, Better Therapeutics said.
The study will assess endpoint data, including change in insulin resistance, blood lipids, inflammation, blood pressure and weight, with eyes on accelerating the development of the company’s product candidates for treating other cardiometabolic conditions.
Better Therapeutics said it is also working with Mass General Brigham, Colorado Prevention Center and Catalyst Health Network to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001.
“We are deeply thankful to our study participants, investigators and partners for their dedication to this study. With their help, we now can demonstrate that use of BT-001 can meaningfully improve upon the Standard of Care,” Better Therapeutics CMO Dr. Mark Berman said in the release. “With roughly half of all patients living with type 2 diabetes not reaching treatment goals despite use of medications, the need for a novel treatment approach is urgent.
“We see tremendous potential for the development of prescription digital therapeutics, such as BT-001, to improve treatment outcomes without adding to the burden of drug-related side-effects.”
