Better Therapeutics seeks US FDA breakthrough device designation for digital therapeutic platform to treat liver disease

Better Therapeutics, Inc., a pioneer in developing prescription digital therapeutics (PDTs) to treat cardiometabolic diseases, announced it has submitted a request to the US Food and Drug Administration (FDA) for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH.

MASLD affects an estimated 25%–30% of adults in the US, including approximately 70% of individuals with type 2 diabetes and up to 90% of those with obesity. The more advanced form of this disease, MASH, affects approximately 5%–11% of American adults and has recently emerged as a leading indication for liver transplant. Despite growing rates of MASLD and MASH, there are currently no FDA approved drug or device treatments.

Behavioral modification is the recommended first-line treatment in clinical practice guidelines to help address many of the root causes and cardiometabolic comorbidities associated with MASLD and MASH. However, systemic accessibility barriers to in-person behavioural therapy exist, preventing a significant number of patients from receiving the care they need. PDTs offer the potential to address the growing need for a clinical tool that healthcare providers can offer patients living with these conditions.

This regulatory step for Better Therapeutics follows the completion of the company’s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. The study 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. The study’s authors concluded the totality of positive efficacy, safety and usability data indicates the potential of Better Therapeutics’ digitally delivered CBT to help address the significant unmet clinical needs observed in MASLD and MASH.

“As a physician dedicated to addressing the complexities of metabolic disorders, witnessing the reduction in liver fat and enzymes within a short timeframe through this digital therapy is not only promising, but represents a groundbreaking advancement to use technology to help facilitate evidence-based treatment,” said Naim Alkhouri, MD, director of the Fatty Liver Programme at Arizona Liver Health and Principal Investigator of the study. “This innovation has the potential to offer effective and scalable support that can make a meaningful impact on those living with MASLD and MASH.”

The FDA’s Breakthrough Device Designation is designed to expedite the development, assessment, and review of devices that demonstrate the potential to address life-threatening or irreversibly debilitating conditions where no approved or cleared alternative treatment options exist. The expected response timeline from the FDA is 60 days after receipt of a Breakthrough Device Designation application.

“Securing Breakthrough Device Designation from the FDA has the potential to accelerate the expansion of our digital therapeutics platform beyond type 2 diabetes,” said Frank Karbe, president and CEO at Better Therapeutics. “The versatility of our therapeutic approach across a broad spectrum of cardiometabolic conditions is an exciting and unique aspect of our platform. Furthermore, the digital nature of our products allows for potential expansion in a fraction of the time and cost compared to traditional drug development.”

Better Therapeutics ended its fiscal year 2023 with cash and cash equivalents of $4.2 million, compared to $6.6 million on September 30, 2023.

Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioural therapy to address underlying factors that sustain or worsen cardiometabolic diseases.

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