Better Therapeutics Completes Exploratory Trial for Fatty Liver Disease and Announces Positive Topline Results

Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing cognitive behavioral therapy (CBT) to address the root causes of cardiometabolic diseases, today 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.

“With approximately 90 million Americans affected by NAFLD, fatty liver disease is a public health crisis that has hit epidemic levels. Because there are currently no FDA approved therapies available to treat these patients, we need to evaluate every possible option to reduce the burden of this condition – and in this study we have found positive topline signals across multiple disease biomarkers for a potential new option in our fight against NAFLD and NASH,” said Mazen Noureddin, MD, Director of the Houston Liver Institute and who served as the Senior Scientific Advisor for the LivVita Study. “Since the cause and progression of these conditions are linked to behavioral factors like diet and activity level, the utilization of a prescription digital therapy that targets these behaviors is compelling and appears to have the potential to make a real difference in this costly disease.”

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
• 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 results seen in the LivVita Study give us confidence that there is merit in further development of treatments for NASH and NAFLD that leverage digital therapies and CBT techniques,” said Naim Alkhouri, MD, Director of the Fatty Liver Program at Arizona Liver Health and Principal Investigator of the study. “We have long understood that making real changes to certain behaviors can result in slowed progression of this disease, but we have not had a reliable, scalable way to deliver the support people need to make them. If we can use smartphones as a delivery mechanism for meaningful therapy, it should certainly become a tool we lean on as we help patients live with these chronic conditions.”