Better Therapeutics, Inc. announced positive topline results of the first-ever study evaluating the feasibility of using a prescription digital therapeutic to reduce liver fat and improve liver disease biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH). The study included a cohort of 22 patients with NAFLD and NASH and used Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) scans, a validated proxy for liver biopsies, to monitor changes in liver fat. Changes in a range of exploratory liver biomarkers were also assessed.

Currently, there is no FDA approved treatment for these conditions, which affect approximately one in four Americans and cause approximately $100 billion in direct medical cost annually. And while some drug candidates are in various phases of research and development, they often present side effects that could limit their utility in patients, if approved. The LivVita Study met its primary endpoint, showing a statistically significant positive signal with an average relative reduction in MRI-PDFF of 16% (p=0.01) in the intent-to-treat population (N=19).

Additional highlights include: A statistically significant mean reduction in Alanine transaminase (ALT) of -17 IU/L (p=0.002); A statistically significant mean change in FAST Score of 20% (p=0.01); No severe adverse events or device related adverse events; and High engagement and patient satisfaction with treatment, with Net Promoter Score of +75 and 94% of subjects still using the app after 90 days. The study relied on Better Therapeutics' CBT platform, which has been developed with the intention of helping patients with cardiometabolic diseases – including NASH and NAFLD – access a tailored treatment that leverages CBT techniques to address underlying causes of these diseases and help them make sustainable behavioral changes. This platform has already shown progress elsewhere, leading to the submission of a de novo classification request for BT-001, Better Therapeutics' prescription digital therapy for type 2 diabetes, currently under review by the FDA.

Better Therapeutics intends to publish these data in a peer-reviewed journal, apply for breakthrough device designation with the FDA, and potentially seek a partner to accelerate development of a NAFLD/NASH specific PDT.