Better Therapeutics Inc (NASDAQ:BTTX) has announced primary endpoint data from its pivotal trial of BT-001 designed to use digitally delivered cognitive-behavioral therapy (nCBT) to treat type 2 diabetes.
- The trial enrolled 669 adults with type 2 diabetes.
- The primary efficacy endpoint (n=602) showed a highly statistically significant improvement in A1c between the intervention and control groups.
- Clinically meaningful changes (A1c reductions of 0.4% or more) occurred in 42.7% of the group receiving standard of care and BT-001 vs. 25.4% in the standard of care alone group.
- No meaningful differences in safety events were observed between groups.
- The six-month trial is ongoing and is expected to be completed in Q2 2022.
- Better Therapeutics intends to file a De Novo classification request with the FDA upon completion of the study.
- Better Therapeutics plans to advance its BT-002 and BT-003 for hypertension and hyperlipidemia, respectively, to pivotal trials after completing its pivotal trial in type 2 diabetes.
- The Company will soon begin clinical research in fatty liver disease to understand the potential of nCBT as a potential treatment.
- Price Action: BTTX shares are up 24.7% at $3.05 during the market session on the last check Tuesday.
