Better Therapeutics, Inc. (NASDAQ: BTTX) is engaged as a prescription digital therapeutics company, which is focused on the research and development of an innovative form of cognitive behavioral therapy (CBT) to address cardiometabolic diseases. Shares of the therapeutics company are rallying 29% through early trading on Thursday, July 28, 2022. Over the past three months, Better Therapeutics has seen average daily volume of 6.78 million shares. However, volume of 30.6 million shares or dollar volume of around $59.98 million, has already exchanged hands through early trading.
Shares of Better Therapeutics are gaining after the company announced that its pivotal clinical trial for BT-001 has met the company’s positive primary and secondary endpoints. BT-001 is an investigational, first-in-class prescription digital therapy that utilizes nutritional cognitive behavior therapy (nCBT) to treat type 2 diabetes. As a result of the positive results, Better Therapeutics says it intends to submit a de novo classification request to the U.S. FDA during the third quarter of 2022.
In March 2022, Better Therapeutics announced the clinical trial had reached its primary endpoints. The secondary endpoint was assessed at day 180 in patients to determine if A1c levels remained stable. The results found patients saw statistically significant decreases in A1c levels compared to the placebo group. This shows that BT-001 has the potential to serve as a meaningful treatment against type 2 diabetes and lowering blood sugar levels, compared to the current standard of treatment.
“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,” said Frank Karbe, president and CEO of Better Therapeutics. “We believe the data from this trial is remarkable, given we enrolled a diverse patient population with advanced disease already on rigorous blood sugar lowering regimens and who could self-select their dose of BT-001, unlike in traditional new drug pivotal trials. 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.”
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