SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a digital prescription therapy company developing nutritional cognitive-behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases, today announced the publication of a manuscript detailing study design and methodology for its pivotal clinical trial of BT-001 in adult patients with type 2 diabetes (T2DM) in the medical journal Clinical Cardiology. The study represents a first-in-class, randomized, controlled clinical trial of a prescription digital therapeutic therapy (PDT) for the treatment of T2DM and is expected to support filing for de novo classification with the Food and United States Drug Administration (FDA). in the third quarter of 2022. The company announced positive primary endpoint data for this trial in March this year and expects to release secondary data in the third quarter of this year.
The manuscript, titled “Cognitive-behavioral therapy delivered via a digital mobile app for the treatment of type 2 diabetes: rationale, design and basic features of a randomized controlled trial”, includes a detailed description of the study design. , efficacy and safety criteria, nCBT protocols embedded in BT-001, statistical considerations, and baseline characteristics of the study population. BT-001 is an investigational digital therapy designed to deliver nCBT via a T2D patient’s smartphone to support dietary change, physical activity and medication adherence for A1c reduction.
“This is one of the largest randomized trials of a digital treatment that includes a diverse population of patients who need more treatment options for their type 2 diabetes,” said Dr. Marc Bonaca. , director of vascular research at the University of Colorado. the data, to date, support a new approach to the treatment of type 2 diabetes that does not just treat the symptoms, but rather addresses the behavioral causes of the disease. This technology holds promise not only for patients with type 2 diabetes, but potentially for those with a wider range of cardiometabolic diseases that share common root causes.
The open-label, randomized, controlled, parallel-group trial evaluated the efficacy and safety of BT-001 and its ability to improve glycemic control in patients with T2DM. Participants were randomized to receive standard treatment 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 . The secondary efficacy endpoint is the change from baseline to day 180. Exploratory endpoints include physical measures, biomarkers, healthcare utilization, and patient-reported outcomes. patients (PRO). Patients receiving standard care took multiple anti-hyperglycemic medications initially and were free to adjust medications as needed. In this way, the design parallels trials of cardiovascular outcomes of other drugs. The clinical trial recruited 669 adults with T2DM and supported the inclusion and exclusion criteria chosen to enroll a representative population of adult outpatients with T2DM in population groups often underrepresented in biotechnology research, including women, minority groups and patients from low socioeconomic status neighborhoods.
The manuscript highlights key potential advantages of digital therapeutics over in-person nCBT, including scalability, standardization of intervention, and ease of access. The latter is particularly important for rural residents and patients with time, mobility or transport constraints. CBT in the clinic is a long-standing and well-studied therapeutic approach, but its widespread use has been limited by inherent access and resource constraints. Digital prescription therapies that digitally deliver nCBT have the potential to overcome these barriers by making behavioral therapy accessible and affordable for millions of patients in need.
About Better Therapeutics
Better Therapeutics is a prescription digital therapy (PDT) company developing a new form of cognitive behavioral therapy to address the root causes of cardiometabolic disease. The company has developed a proprietary platform for the development of FDA-regulated prescription software solutions for type 2 diabetes, heart disease and other conditions. Nutritional Cognitive Behavioral Therapy delivered by Better Therapeutics PDT is designed to enable changes in the neural pathways of the brain so that lasting behavioral changes become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while reducing healthcare costs. Better Therapeutics’ clinically validated mobile apps are intended to be prescribed by doctors and reimbursed like traditional medicines.
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Certain statements made in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are generally identified by words such as “plan”, “believe “, ” to expect “, “to anticipate,” “intention,” “outlook,” “estimate,“forecast”, “project”, “Carry on,“could”, “could”, “could”, “could”, “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. 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, plans for Better Therapeutics regarding FDA submissions, expectations related to the potential benefits of BT-001 and CBT and their potential treatment applications, Better Therapeutics’ plans regarding research and advancement of its product candidates for additional treatments, expectations related to healthcare providers’ and payers’ interest 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 Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statements. There can be no assurance that future developments will be those anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that could cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements, including: risks relating to the business of Better Therapeutics, such as the FDA’s willingness to clear PDTs for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates and other risks and uncertainties included under the heading “Risk factorsin the definitive proxy statement/prospectus that we filed on October 12, 2021.