Better Therapeutics (Nasdaq:BTTX) announced today that it completed the pivotal trial for its BT-001 digital therapeutic for diabetes.
San Francisco-based Better Therapeutics designed its nutritional cognitive behavioral therapy (nCBT) platform to address the root causes of cardiometabolic diseases. It designed its investigational, first-in-class BT-001 prescription digital therapeutic (PDT) to use nCBT to treat type 2 diabetes.
According to a news release, the trial produced positive data, leading the company to plan to submit a de novo classification request to the FDA in the third quarter of 2022 to try and garner marketing authorization. The company said, if granted, BT-001 would become the first authorized PDT for treating type 2 diabetes.
“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,” Better Therapeutics President and CEO Frank Karbe said in the release. “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.”
In March, the company reported that its trial had met its primary endpoint at day 90 and the secondary endpoint at 180 days announced today continued the same trend of statistically significant decreases in A1c levels when compared to a control group receiving standard of care. Results were sustainable and improved between day 90 and day 180, Better Therapeutics said, demonstrating the ability of BT-001 to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on standard of care blood sugar lowering medications.
The company also said that exploratory data revealed a range of cardiometabolic improvements as well as lower medication utilization compared to the control group, supporting the potential for BT-001 to improve the overall health of patients and potentially reduce the usage of increasingly costly medications associated with the progression of the disease.
“As a physician focused on cardiometabolic conditions, it’s a rare and important moment to see an entirely new treatment paradigm emerge for patients with T2D, but that’s what we potentially have with this digital therapeutic approach,” Better Therapeutics CMO Dr. Mark Berman said. “For too long, the treatment options available to people with T2D have largely been prescription medications that help reduce symptoms but do little to address the underlying causes of disease. This pivotal trial of digitally delivered nCBT in a complex patient population with advanced and difficult-to-treat disease generated results that were durable and a notable improvement over the current standard of care. The results also suggest that BT-001 has the potential to reduce the need for medications and lower healthcare utilization.”
The study of 668 adults with type 2 diabetes and mean baseline A1c of 8.1% produced evidence of the average A1c reduction in patients using BT-001 improving from 0.3% at day 90 to 0.4% at day 180, supporting that the treatment effects of BT-001 were durable. Additionally, the difference in A1c levels after 180 days between BT-001 and standard of care patients remained statistically significant as more standard of care patients increased blood sugar-lowering medications.
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, while BT-001 demonstrated reassuring safety with fewer adverse and serious adverse events compared to standard of care.
“The results of this trial are not just encouraging for patients with T2D mellitus but mark the start of a potential sea change in how we approach treatment of cardiometabolic diseases and their root causes,” said Dr. Marc Bonaca professor of medicine and director of vascular research, University of Colorado. “If we can deliver a scalable, sustainable and clinically validated way to make important and durable improvements in cardiometabolic disease, we can empower patients to take back control of their health from these costly, common chronic diseases.”