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Better Therapeutics health app for liver disease treatment receives FDA breakthrough status

March 6, 2024

Better Therapeutics, a prescription digital therapeutics company known for its cognitive behavioral therapy (CBT) designed to address underlying factors of cardiometabolic diseases, was granted the FDA’s Breakthrough Device Designation for its CBT platform used to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). The company’s CBT platform had already demonstrated clinically meaningful outcomes in treating type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx in July 2023.

FDA 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. The breakthrough designation allows the company to work toward marketing authorization for the platform in MASH. (Better Therapeutics, 2024; Taylor, 2024)

What’s the potential patient impact?

According to the American Liver Foundation, one in four American adults is estimated to have nonalcoholic fatty liver disease (NASH), now referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). MASLD is the most common cause of chronic liver disease and the leading cause of liver-related morbidity and mortality. The more advanced form of the condition, MASH, affects approximately 5-11% of American adults. The projected prevalence of MASLD and MASH is projected to grow, contributing to an increasing risk for patients and a burden to the health care system. There are currently no approved treatments for these conditions; rather, the standard of care guidelines emphasize the importance of lifestyle behavioral changes and reducing cardiometabolic risk. (Alkhouri, 2023)

Previous studies have found that behavioral changes that reduce body weight and increase physical activity can slow or reverse the buildup of fat and scarring of the liver in patients with MASH. However, long-term adherence to these changes can be difficult to maintain. According to Better Therapeutics, digital CBT is designed to provide a safe, effective, and scalable treatment option for patients with MASLD and MASH, like what the company offers for T2D. (Alkhouri, 2023; Better Therapeutics, 2024)

How does it work?

Better Therapeutics’ CBT platform works by targeting lifestyle behaviors known to cause and/or contribute to the progression of metabolic diseases. According to the company’s news release, the platform was developed to address the current gap in broadly accessible and standardized intensive behavioral therapies that enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment. (Better Therapeutics, 2024)

What does the evidence show?

The FDA awarded the designation based on the results of Better Therapeutics’ 22-subject, single-arm LivVita clinical trial, which successfully met its primary endpoint by reducing liver fat within 90 days, and achieved key secondary endpoints related to improved liver health without any device-related adverse events. This first-of-its kind study of a prescription digital therapeutic in patients with MASH/MASLD demonstrated improvements across multiple markers, including MRI-PDFF, FibroScan score, and weight. Subjects had lower liver fat after using software designed to improve dietary quality and physical activity for 90 days. The author tracked more than 16% reduction in the 14 subjects included in the efficacy analysis. Results from the study were published in Gastro Hep Advances. (Alkhouri, 2023; Better Therapeutics, 2024)

Sources:

(2024, February 20). Better Therapeutics. Advanced Liver Disease. [News release]. https://investors.bettertx.com/news-releases/news-release-details/better-therapeutics-receives-fda-breakthrough-device-designation

Alkhouri, N et al. (2023, October 1). Gastro Hep Advances. A novel prescription digital therapeutic option for the treatment of metabolic dysfunction-associated steatotic liver disease. https://www.ghadvances.org/article/S2772-5723(23)00143-7/fulltext

Taylor, NP. (2024, February 21). MedTech Dive. Better Therapeutics wins breakthrough status for health app to treat liver disease. https://www.medtechdive.com/news/better-therapeutics-breakthrough-liver-disease/708034/