Better Therapeutics Announces Positive Primary Endpoint Data From Pivotal Clinical Trial of BT-001, a Prescription Digital Therapeutic (PDT) for Patients With Uncontrolled Type 2 Diabetes
Data Demonstrates Clinically Meaningful and Statistically Significant Results, Improving Glycemic Control by Reducing A1c 0.4% Versus the Control Group Receiving Standard of Care
The open label, randomized, controlled, parallel group trial enrolled 669 adults with type 2 diabetes and mean baseline A1c of 8.1%. Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. Following is an overview of key takeaways from the 90-day data:
- The clinical trial included a diverse, nationally representative patient population including participants from minority groups often underrepresented in diabetes studies. 40.2% of participants were non-white; 15.7% were Hispanic or Latin American.
- Participants had long-standing type 2 diabetes, high cardiovascular risk, multiple comorbidities with use of multiple medications.
- The primary efficacy endpoint (n=602) showed highly statistically significant improvement in A1c between the intervention and control groups (-0.4%, p <0.001).
- Clinically meaningful changes (A1c reductions of 0.4% or more) occurred in 42.7% of the group receiving standard of care and BT-001 vs. 25.4% in the group receiving standard of care alone (difference of 17.3%, p <0.001); we believe this demonstrates use of BT-001 significantly improved A1c compared to standard of care alone.
- There was a clear dose-response between greater engagement in nCBT and greater reductions in A1c, supporting nCBT as a mechanism of action.
- Measures of patient engagement, adherence, persistence, and satisfaction were all positive.
- No meaningful differences in safety events were observed between groups.
The six-month trial is ongoing and is expected to be completed in Q2 2022. Given the compelling benefit-to-risk profile of BT-001 and highly statistically significant 0.4% reduction in A1c,
“The data we’re unveiling today is a critical step in our journey to reimagine how cardiometabolic diseases are treated. By demonstrating that BT-001 can improve glycemic control at 90 days by addressing the behaviors that are root causes of type 2 diabetes, even in a very sick, poorly controlled population with long-standing diabetes, we not only open a new avenue of potential treatment, but a new horizon for non-pharmaceutical approaches to care,” said Dr.
“The existing treatment paradigm for type 2 diabetes relies almost exclusively on the use of traditional medications to address the symptoms of the disease, while doing very little about the behaviors that are the underlying causes. We created nutritional CBT delivered as a prescription digital therapeutic to fill a known gap in clinical care,” said
BT-001 is part of a new class of PDTs that are increasingly garnering interest from health care providers and payers. The
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Certain statements made in this press release are "forward-looking statements" within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding the timing and results of the ongoing trial of BT-001 in patients with type 2 diabetes, Better Therapeutics’ plans regarding FDA submissions, expectations related to the potential benefits of BT-001 and CBT and their potential treatment applications, Better Therapeutics’ plans regarding the research and advancement of its product candidates for additional treatments, expectations related to the interest of healthcare providers and payers in PDTs and legislative developments affecting PDTs and the outcome of such developments, among others. These forward-looking statements are based on the current expectations of the management of
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