Dive Brief:
- Better Therapeutics has received breakthrough device status for a digital therapeutic designed to treat adults with advanced liver disease, the company said Tuesday.
- The Food and Drug Administration awarded the designation after seeing the results of a clinical trial that linked the digital cognitive behavioral therapy (CBT) to reductions in liver fat.
- Better Therapeutics won FDA authorization in Type 2 diabetes in July but, like the wider digital therapeutics sector, has struggled to allay concerns about commercialization. The company has discussed substantial doubts about its ability to continue as a going concern.
Dive Insight:
The breakthrough designation covers the use of Better Therapeutics’ platform in the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH). Studies have found 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, a condition that was previously called nonalcoholic steatohepatitis.
However, lifestyle changes have proven hard to maintain. Clinicians report that they lack the “training, tools and time to effectively deliver lifestyle interventions,” and adherence to changes that help reduce body weight is a long-standing problem.
The situation is analogous to other conditions, such as substance use disorder, where behavior change is needed but challenging to facilitate and maintain because of healthcare capacity constraints. Digital CBT is designed to alleviate those constraints by using apps, rather than individuals, to deliver therapy.
Better Therapeutics’ work to establish the model in MASH advanced in October, when a paper published in the journal Gastro Hep Advances described results from a 22-subject, single-arm clinical trial. Subjects had lower liver fat after using software designed to improve dietary quality and physical activity for 90 days. The authors tracked a more than 16% reduction in the 14 subjects included in the efficacy analysis.
Last month, Better Therapeutics filed for breakthrough device designation on the strength of the data. The receipt of the designation this week positions the company to interact with FDA experts as it works to generate and submit data to support authorization in MASH.
In early November, Better Therapeutics told investors it had enough cash to fund operations into the first quarter of 2024. Changes disclosed at the end of November were expected to extend the runway enough to show “commercial traction” for the Type 2 diabetes product.
Other companies, notably Pear Therapeutics, have struggled to commercialize digital therapeutics. Pear filed for bankruptcy in April 2023 after failing to meet revenue goals for its FDA-authorized insomnia and substance use disorder apps. Diane Gomez-Thinnes, chief commercial officer at Better Therapeutics, set out how she has approached commercialization of the diabetes app AspyreRx on an earnings call.
“Our strategy has always been to be extremely focused, really carefully managing our resources,” Gomez-Thinnes said in November. “The work we’ve done has really been to identify where the highest concentration of high-volume targeted providers are. We expect to be these early adopters of AspyreRx.”
The company also disclosed a rebate agreement with a pharmacy benefit manager two weeks ago.