Benzinga | Nov 18, 2021 08:09AM EST

Better Therapeutics Completes Enrollment Of Pivotal Trial For BT-001, A Prescription Digital Therapeutic For Type 2 Diabetes

Better Therapeutics, Inc. (("Better Therapeutics", NASDAQ:BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, today announced the completion of patient enrollment in its potentially pivotal study to evaluate the safety and efficacy of BT-001 for the treatment of type 2 diabetes.

BT-001 is being developed as an FDA-regulated, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes. The study exceeded its target, enrolling 662 patients from California, Illinois, Florida, Georgia, New York, and Texas.

"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," said Mark Berman, M.D., chief medical officer of Better Therapeutics. "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."

If positive, study results may support a regulatory submission for marketing authorization from the U.S. Food & Drug Administration (FDA). Exploratory endpoint data captured during this study, including change in insulin resistance, blood lipids, inflammation, blood pressure and weight, could accelerate the development of Better Therapeutics' product candidates to treat other cardiometabolic conditions.

Better Therapeutics is also conducting a real-world evidence study 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. It is expected that primary care providers will prescribe, and insurers will reimburse the company's therapeutics much like they would a traditional medication.

The Better Therapeutics platform blends clinical, behavioral, and psychological inputs into a series of therapy lessons and skill-building modules. These are designed to isolate and shift the underlying thoughts and beliefs which guide diet and lifestyle behaviors that cause a wide range of cardiometabolic diseases, including type 2 diabetes.

Clinical data on the efficacy and safety of Better Therapeutics developmental product candidates has been published in multiple peer-review journals including Journal of the Endocrine Society, JMIR Cardio, JMIR Diabetes and more.