Why Are Better Therapeutics Shares Gaining Today?

Better Therapeutics Inc BTTX shares are trading higher after the FDA approved the company's AspyreRx (formerly BT-001), a prescription-only digital treatment to provide cognitive behavioral therapy to adult patients with type 2 diabetes. 

AspyreRx, expected to launch commercially in Q4 2023​, is the first prescription digital behavioral therapeutic device delivering a novel form of cognitive behavioral therapy via smartphone.

AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results published in Diabetes Care.

The trial met its primary and secondary endpoints showing statistically significant decreases in HbA1c levels compared to a control group receiving standard of care and a control app. 

The results were sustained and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable reductions in blood sugar for a complex range of patients with T2D.

1 in 2 people achieved a mean A1c reduction of 1.3% after 180 days of use.

On average, subjects who used BT-001 also experienced a host of cardiometabolic improvements compared to subjects who did not use BT-001.

A clear dose response between greater engagement in CBT and greater reductions in HbA1c was found, supporting CBT as a mechanism of action to generate positive clinical outcomes.

Patient engagement and adherence were excellent, with 94% of the participants using the intervention at day 90 and 81% still engaged at day 180.

Price Action: BTTX shares are up 45.60% at $1.31 on the last check Tuesday.