Better Therapeutics (Nasdaq:BTTX) announced today that the FDA granted breakthrough device designation for its MASH treatment.
The company’s prescription digital therapeutic (PDT) delivers novel cognitive behavioral therapy (CBT). It aims to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.
This novel form of CBT targets the lifestyle behaviors known to cause and/or contribute to the progression of metabolic diseases. The company developed its platform 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. Its AspyreRx PDT for type 2 diabetes received FDA clearance and launched last year.
Better Therapeutics said in a news release that it earned a breakthrough nod based on the outcomes of its LivVita clinical study. The trial successfully met its primary endpoint by reducing liver fat within 90 days. It also achieved key secondary endpoints related to improved liver health without any device-related adverse events.
“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 CEO at Better Therapeutics. “This also reinforces the potential for our therapeutics platform to broadly address metabolic disorders.”