Why Better Therapeutics Shares Are Surging During Premarket Session

  • Better Therapeutics Inc BTTX completed the pivotal clinical trial for BT-001, an investigational prescription digital therapeutic designed to use nutritional cognitive behavioral therapy (nCBT) to treat type 2 diabetes (T2D).
  • The company plans to submit a de novo classification request to the FDA in Q3 of 2022.
  • If approved, BT-001 would become the first prescription digital therapeutic for the treatment of T2D.
  • This data follows the announcement in March that the trial had met its primary endpoint.
  • The data showed sustained and improved A1c (blood sugar) levels in patients using BT-001, with average absolute A1c reduction improving from 0.3% at day 90 to 0.4% at day 180.
  • The difference in A1c levels after 180 days of treatment between BT-001 treated patients, and Standard of Care (SOC) control group patients receiving standard of care remained statistically significant.
  • Half of the patients using BT-001 experienced clinically meaningful A1c reductions with a mean reduction of 1.3% in this subgroup at 180 days.
  • Results indicated that patients who did not use BT-001 were more likely to be placed on additional medications to improve A1c control. 
  • BT-001 demonstrated reassuring safety, with significantly fewer adverse events than the SOC control group.
  • Price Action: BTTX shares are up 54.90% at $2.37 during the premarket session on the last check Thursday.
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