Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the FDA for its BT-001 technology.
San Francisco-based Better Therapeutics seeks marketing authorization for the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. Marketing initially would cover type 2 diabetes patients aged 18 years and older.
In July, the company completed the pivotal trial for its BT-001 digital therapeutic for diabetes. It said at the time that the positive data supports its coming claim for FDA authorization.
Its study of 668 adults with type 2 diabetes and mean baseline A1c of 8.1% produced evidence of the average A1c reduction in patients using BT-001 improving from 0.3% at day 90 to 0.4% at day 180, supporting that the treatment effects of BT-001 were durable. Additionally, the difference in A1c levels after 180 days between BT-001 and standard of care patients remained statistically significant as more standard of care patients increased blood sugar-lowering medications
“Submitting this de novo request is not just a major milestone for our company but an important moment for patients, providers and payers. As the first digital therapeutic submitted to the FDA for the treatment of type 2 diabetes, BT-001 marks a new kind of treatment paradigm with the potential to address the root causes of this and other cardiometabolic diseases,” said Dr. Mark Berman, CMO, Better Therapeutics. “By providing people with convenient, personalized treatment rooted in decades of behavioral science, we aim to help them take back control and live healthier lives, instead of relying on increasingly costly pharmaceutical treatments that place undue burden on patients and fail to address the behavioral root causes of disease.”
Additional exploratory data found a range of cardiometabolic improvements, Better Therapeutics said. It also lowered medication utilization compared to control. This supports BT-001 in improving overall health and potentially reducing costs associated with diabetes medications.
Better Therapeutics said BT-001 would be the first validated, prescription solution for delivering CBT to type 2 diabetes patients at scale from their digital devices. The company is exploring the use of CBT in other cardiometabolic conditions. These include nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, and hyperlipidemia.