Better Therapeutics BTTX announced positive results from its pivotal clinical trial for BT-001, prescription digital therapeutic that is designed to use nCBT to treat c diabetes (T2D).
The secondary endpoint data of the study assessed at day 180 continued this trend, showing statistically significant decreases in A1c levels when compared to a control group receiving standard of care (p-value = 0.01).
Earlier in the month of March, 2022, The company announced that the trial had met its primary endpoint at day 90 with a p-value of < 0.0001.
As the pivotal study is concluded, the company now intends to submit a de novo classification request to the regulatory agency in the third quarter of 2022, seeking marketing authorization for BT-001 for the treatment of patients with T2D.
Frank Karbe, president and CEO, commented: "Today's announcement is a moment to celebrate – not just for the team at Better Therapeutics – but for the patients and health care providers who know all too well that the way we treat T2D today simply isn't good enough given the magnitude of this epidemic disease, The positive data from this trial serves as an important stepping stone towards our goal of bringing BT-001 to patients and physicians in need of new therapies, and entering the next phase of our growth as a commercial-stage company.”
Price Action : Better Therapeutics shares are trading around 60 percent higher at $2.45 on Thursday during pre-market session.
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