Better Therapeutics Announces Publication of the Rationale, Design and Baseline Characteristics Manuscript for Type 2 Diabetes Pivotal Trial of BT-001, a Novel Prescription Digital Therapy, in Clinical Cardiology
Better Therapeutics, Inc. (NASDAQ: BTTX) announced the publication of a manuscript in Clinical Cardiology detailing the pivotal trial design for BT-001 in treating type 2 diabetes (T2D). This is the first randomized controlled trial of a prescription digital therapeutic for T2D. Positive primary endpoint data were reported in March, with secondary data expected soon. The trial included 669 diverse T2D patients, targeting accessibility to behavioral therapy through a mobile app. The company plans to submit a de novo classification request to the FDA by Q3 2022.
- Successful primary endpoint results from BT-001 trial reported in March.
- Publication in a reputable medical journal enhances credibility.
- Diverse patient enrollment promotes broader applicability of findings.
- Potential for high scalability of digital therapeutic solutions.
- Dependence on FDA approval for commercialization of BT-001.
- Market risks due to potential insurance non-reimbursement for PDTs.
The manuscript, titled, “Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial,” includes a detailed description of study design, efficacy and safety endpoints, the nCBT protocols embedded in BT-001, statistical considerations and baseline characteristics of the study population. BT-001 is an investigational digital therapeutic designed to provide nCBT via a T2D patient’s smartphone to support dietary change, physical activity and medication adherence for the reduction of A1c.
“This is one of the largest randomized trials of a digital therapeutic that includes a diverse population of patients that need more treatment options for their type 2 diabetes," said Dr.
The open-label, randomized, controlled, parallel group trial evaluated the efficacy and safety of BT-001 and its ability to improve glycemic control among patients with T2D. 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. The secondary efficacy endpoint is the change from baseline to Day 180. Exploratory endpoints include physical measures, biomarkers, healthcare utilization, and patient-reported outcomes (PRO). Patients receiving standard of care were on multiple anti-hyperglycemic meds at baseline and free to adjust meds as needed. In this way, the design parallels cardiovascular outcome trials of other medications. The clinical trial enrolled 669 adults with T2D and supported inclusion and exclusion criteria chosen to enroll a representative population of adult outpatients with T2D across population groups often underrepresented in biotech research, including women, minority groups and patients in low socioeconomic status neighborhoods.
The manuscript highlights key potential advantages of the digital therapeutic over in-person nCBT, which include its scalability, standardization of the intervention, and ease of access. The latter is particularly important for rural residents and patients with time, mobility or transportation limitations. In-clinic CBT is a long-standing and well-studied therapeutic approach, but broad utilization has been limited by inherent access and resource constraints. Prescription digital therapeutics that digitally deliver nCBT have the potential to overcome these obstacles by making behavioral therapy accessible and affordable to millions of patients in need.
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Forward-Looking Statements
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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