Pivotal trial of BT-001 in type 2 diabetes fully enrolled; interim data analysis determines trial is adequately powered and should continue to completion without changes; primary endpoint readout expected in Q1 2022
Early clinical discovery study in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) expected to commence enrollment in Q1 2022
Mass General Brigham (MGB) joins Colorado Prevention Center (CPC) and Catalyst Health Network (Catalyst) in real-world evidence initiative evaluating the long-term effectiveness and healthcare cost impact of BT-001 expected to commence enrollment in Q1 2022
Recent additions to the leadership team include Chief People and Chief Strategy Officers, and Senior Vice President of Clinical Development
Chardan, Cowen and Company, Lake Street Capital Markets and LifeSci Capital have initiated coverage of BTTX since its public debut on NASDAQ
Better Therapeutics, Inc. (“Better Therapeutics”; NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing cognitive behavioral therapy to address root causes of cardiometabolic diseases, today provided an update on recent progress.
“We’ve made excellent progress since debuting as a public company,” said Kevin Appelbaum, co-founder and chief executive officer of Better Therapeutics. “Our clinical development pipeline across multiple product candidates is progressing as planned. Our potentially pivotal study of BT-001, a PDT for treating type 2 diabetes, is now fully enrolled and primary endpoint data is expected later this quarter. Mass General Brigham has joined our research effort to evaluate the long-term effectiveness and impact on health care utilization and medication use in real-world clinical practice alongside CPC and Catalyst, and all three sites will be enrolling patients this quarter. We strengthened our team with key additions across all functions. We also recognize we are in the very early stages of creating a new modality for treating diseases caused by behaviors using regulated and prescribed software instead of molecules, and are pleased to have multiple analysts doing independent research on our company in order to educate investors about the PDT opportunity in general, and Better Therapeutics in particular.”
The Better Therapeutics platform blends clinical, behavioral and psychological inputs into a series of cognitive behavioral therapy lessons and skill-building modules designed to shift neural pathways of the brain and treat the disease at its source through behavior change. If the FDA provides marketing authorization, it is anticipated that primary care providers will prescribe, and insurers will reimburse, Better Therapeutics’ PDTs much like they would a traditional medication.
Clinical data on the efficacy and safety of Better Therapeutics developmental product candidates has been published in multiple peer-review journals including Journal of the Endocrine Society , JMIR Cardio , JMIR Diabetes and more.
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. For more information visit: bettertx.com
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220106005199/en/
Heidi Chokeir, Ph.D.
+1 619 203 5391