SAN FRANCISCO, Calif. — Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Breakthrough status is reserved for technologies that demonstrate the potential to be more effective than current standard of care in patients with serious or life-threatening conditions.
Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances.
“With breakthrough device designation in hand, we now have a pathway to accelerate the attainment of marketing authorization for a potential second indication and we are actively seeking strategic partnerships to expedite the development and commercialization of this therapy for the millions of patients with advanced liver disease,” said Frank Karbe, President and Chief Executive Officer at Better Therapeutics. “This also reinforces the potential for our therapeutics platform to broadly address metabolic disorders.”
Better Therapeutics’ novel form of CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. The platform was developed to address the current gap in broadly accessible and standardized intensive behavioral therapies that effectively enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment. The Company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx™ in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D.
“Earning breakthrough status is a significant milestone and underscores the potential for digitally delivered CBT to offer a vital option for patients with MASH, where very few alternatives exist,” said Naim Alkhouri, MD, Director of the Steatotic Liver Program at Arizona Liver Health and Principal Investigator of the LivVita Liver Study. “We are committed to advancing this innovative therapy and look forward to its potential to transform the lives of those affected by MASH.”
About MASH
MASH represents an advanced stage of metabolic dysfunction-associated steatotic liver disease (MASLD), a condition tied to the escalating obesity and diabetes epidemics. One in four American adults is estimated to have MASLD, with up to 16.5 million adults diagnosed with severe liver complications, including MASH.
MASH is a leading cause of liver related mortality and an increasing burden on healthcare systems globally. Additionally, patients with MASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.
About AspyreRx
AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access from their smartphone. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDTs 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.
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