Better Therapeutics Seeks FDA Approval For First Digital Therapeutic For Type 2 Diabetes

Better Therapeutics Inc BTTX has submitted a de novo classification request to the FDA seeking approval for BT-001 digital therapeutic designed to use CBT to treat Type 2 Diabetes (T2D) in adult patients.
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 Mark Berman, Chief Medical Officer of Better Therapeutics.
This submission follows positive results from the BT-001 pivotal trial that met 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 their use of blood sugar lowering medications.
In addition, exploratory data revealed a host of cardiometabolic improvements and lower medication utilization compared to the control group, supporting the potential for BT-001 to improve patients' overall health.
If authorized by the FDA, BT-001 would be the first validated prescription solution for delivering cognitive behavioral therapy (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.
Price Action: BTTX shares are up 0.40% at $1.90 on the last check Thursday.