- Better Therapeutics Inc BTTX submitted a New Classification Application with the FDA to seek approval for digital therapeutic BT-001, which is being developed 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 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 template follows positive results from the pivotal BT-001 study, which met its primary and secondary endpoints and demonstrated statistically and clinically meaningful reductions in A1c from the current standard of care, even as patients in the control group increased their anti-hyperglycaemic medication use.
- Additionally, exploratory data demonstrated a variety of cardiometabolic improvements and lower drug consumption compared to the control group, supporting the potential of BT-001 to improve overall patient health.
- If approved 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 approved, Better Therapeutics is investigating the potential of using CBT for other cardiometabolic diseases.
- Price promotion: BTTX shares are up 0.40% to $1.90 on the last check Thursday.
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