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Better Therapeutics (NASDAQ: BTTX) has enrolled its first patient in a real-world evidence study to evaluate the long-term effectiveness of BT-001, a prescription digital therapeutic aimed at treating type 2 diabetes. The study is conducted in collaboration with Colorado Prevention Center and seeks to assess healthcare utilization and medication changes. This milestone is part of a multi-year study that may provide insights into glycemic control and healthcare cost reduction, with expectations of delivering robust, real-world data.
Positive
Enrollment of the first patient in a real-world study for BT-001.
Study aims to provide insights on healthcare utilization and medication changes.
Potential for generating robust data on glycemic control and cost reduction.
Negative
Potential uncertainties regarding FDA approval and insurance reimbursement.
Open-label, randomized, controlled study will evaluate BT-001, a prescription digital therapeutic (PDT) delivering cognitive behavioral therapy to address behavioral root cause of type 2 diabetes
Multi-year study will evaluate effectiveness, durability, healthcare utilization and medication changes associated with use of BT-001 in a diverse patient population and real-world clinical setting
SAN FRANCISCO--(BUSINESS WIRE)--
Better Therapeutics, Inc. (“Better Therapeutics”, NASDAQ: BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, in partnership with Colorado Prevention Center (CPC) Clinical Research, today announced the first patient has been enrolled in a real-world evidence study to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001 for the treatment of type 2 diabetes. The open-label, randomized, controlled study is actively recruiting patients with type 2 diabetes from the University of Colorado Health System.
“CPC is excited to commence enrollment within the University of Colorado Health System to understand how BT-001 impacts cardiometabolic risk and healthcare utilization in our diverse, type 2 diabetes population by addressing the behavioral root causes of this complex and prevalent condition,” said Marc Bonaca, MD, MPH, executive director of CPC Clinical Research and CPC Community Health. “We look forward to providing regular updates on progress and outcomes to evaluate the long-term durability of effectiveness and cost of care impact.”
“Today’s announcement marks the second real-world study collaborator initiating enrollment within the last six months and an important milestone for Better Therapeutics,” said Mark Berman, MD, chief medical officer of Better Therapeutics. “CPC’s contribution to our multi-year real world evidence study will generate robust data demonstrating the potential to improve and maintain glycemic control and reduce ongoing healthcare costs and medications that payers can use to assess for coverage reimbursement.”
About Colorado Prevention Center (CPC) Clinical Research
CPC Clinical Research, an academic research organization and an affiliate of the University of Colorado Anschutz Medical Campus, is a mission-driven non-profit organization that exists to improve health through innovative science and community engagement. For over 30 years, CPC has been a leader in research and implementation, experienced in clinical trial design, oversight, and management, including registration trials (Phase I-IV), real-world data, and pragmatic trials. Members of CPC’s leadership team are experienced faculty of the university and have chaired and/or served on FDA advisory committees, including the Cardiovascular and Renal, Endocrine and Metabolism, and Reproductive Health committees. Through our Community Health Programs, we develop innovative and evidence-based health promotion programs, interactive health technology, and community partnerships to help win the fight against cardiovascular disease in Colorado. As a result of these efforts, CPC Community Health has provided health education and/or coaching to over 82,000 individuals and made significant improvements in the lives of those at risk for cardiovascular disease.
Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases. The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions. The cognitive behavioral therapy delivered by Better Therapeutics’ PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.
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 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 statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics’ business, such as the willingness of the FDA to approve PDTs and insurance companies to reimburse their use; and other risks and uncertainties included under the header “Risk Factors” in the definitive proxy statement/prospectus filed by us on October 12, 2021.
What is the purpose of the BT-001 study conducted by Better Therapeutics?
The study aims to evaluate the long-term effectiveness and healthcare utilization changes associated with BT-001, a digital therapeutic for type 2 diabetes.
When was the first patient enrolled in the BT-001 study?
The first patient was enrolled recently, marking an important milestone for Better Therapeutics in their multi-year study.
Where is the BT-001 study taking place?
The study is being conducted in partnership with the Colorado Prevention Center and involves patients from the University of Colorado Health System.
What are the expected outcomes of the BT-001 study?
The study is expected to provide insights into the effectiveness of BT-001 in improving glycemic control and its impact on healthcare costs.
How can the results of the BT-001 study impact the market for Better Therapeutics?
Positive results could enhance market confidence and support reimbursement strategies, influencing stock performance for Better Therapeutics (BTTX).
