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Better Therapeutics, Inc (NASDAQ: BTTX) announced a call on March 25, 2022, to discuss top-line results from its pivotal clinical trial for BT-001, a digital therapeutic aimed at treating type 2 diabetes. The trial showed a clinically significant reduction in A1c levels by -0.4% (p<0.001) without any adverse effects. The company plans to submit a de novo classification request to the FDA following the trial's completion in Q2 2022. The call will focus on the clinical significance of the results and future research expectations.
Positive
Achieved a statistically significant reduction in A1c levels by -0.4% (p<0.001) in the trial for BT-001.
No adverse effects reported after 90 days in the clinical study.
Plans to file a de novo classification request with the FDA following trial completion in Q2 2022.
Negative
None.
Leading Medical Experts to Discuss Top-Line Results Showing Significant Glycemic Improvement Using BT-001
SAN FRANCISCO--(BUSINESS WIRE)--
Better Therapeutics, Inc. (“Better Therapeutics”, NASDAQ: BTTX), a prescription digital therapeutics company developing nutritional cognitive behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases, today announced that it will hold a call this Friday, March 25, to provide a deeper look at the results from the company’s pivotal clinical trial for BT-001, a prescription digital therapeutic for type 2 diabetes.
Last week, the company shared the primary endpoint results from this milestone trial, which demonstrated clinically meaningful and statistically significant improvement in A1c, a measure of sugar in the blood, between the intervention and control groups (difference of -0.4%; p<0.001) and no device or study-related adverse effect after 90 days. The company also indicated that it plans to file a de novo classification request with the FDA following trial completion in Q2 2022.
WHEN: Friday, March 25, 2022 – 1:00 PM ET
WHAT: The call will be hosted by Rahul Rakhit, an equity research analyst with LifeSci Capital, and will provide an opportunity to take a deeper look at the clinical significance of this safety and efficacy data and will provide additional context for how BT-001 may be used in the current treatment paradigm. It will also cover expectations and considerations for the 180-Day readout of the study data in Q2, as well as the upcoming Real World Evidence study in Q3.
WHO: Dr. Mark Bermanserves as Better’s Chief Medical Officer. Previously, he practiced as an internal and lifestyle medicine physician at One Medical. Dr. Berman received his M.D. from Yale. He completed residency at Harvard’s Brigham and Women’s Hospital and a clinical research fellowship at University of California, San Francisco. He has also served as a director of the American College of Lifestyle Medicine
Dr. Marc Bonacais a Cardiologist and Vascular Medicine Specialist who serves as the Executive Director of CPC Clinical Research and CPC Community Health which is an Academic Research Organization created by and affiliated with the University of Colorado Anschutz Medical Campus. Dr. Bonaca has extensive experience in the design and conduct of large multicenter randomized clinical trials as well as analyses in registries and real-world datasets. His key areas of interest include patients with peripheral artery disease, polyvascular disease and diabetes with a focus on the breadth of risk including ischemic limb outcomes, microvascular complications, and major adverse cardiovascular events. Other clinical research interests include the evaluation of novel antithrombotic, lipid lowering and glucose lowering drugs, and the use of established and novel biomarkers or risk prediction and personalization of therapy. He is a member of the Society of Vascular Medicine, American College of Cardiology (ACC) and American Heart Association (AHA). He currently serves on the ACC PVD Leadership Council and is an associate editor for the Vascular Medicine.
WHERE: To attend the call, please email Robert Fromberg (rfromberg@lifescicapital.com) to register and receive the dial-in information. Additionally, a replay link will be available following the call at investors.bettertx.com.
About Better Therapeutics
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 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 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 authorize 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 header “Risk Factors” in the definitive proxy statement/prospectus filed by us on October 12, 2021.
