Better Therapeutics, Inc. announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for BT-001, its potentially first-in-class digital therapeutic designed to use CBT to treat Type 2 Diabetes (T2D) in patients 18 years and older. This submission follows positive results from the BT-001 pivotal trial, the largest randomized control study ever conducted of a digital therapeutic to evaluate glycemic response in T2D. The trial met both its primary and secondary endpoints demonstrating statistically and clinically meaningful reductions in A1c over the current standard of care, even as control group patients increased use of blood sugar lowering medications.

The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on standard of care blood sugar lowering medications. In addition, exploratory data revealed a host of cardiometabolic improvements as well as lower medication utilization compared to the control group, supporting the potential for BT-001 to improve the overall health of patients with T2D and potentially reduce the usage of increasingly costly T2D medications associated with the progression of the disease. If authorized by the FDA, BT-001 would be the first validated, prescription solution for delivering CBT to T2D patients at scale, from their digital devices.

In addition to treating T2D with BT-001, if authorized, Better Therapeutics is exploring the potential to use CBT for other cardiometabolic conditions, including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, and hyperlipidemia.