Better Therapeutics' first digital app earns FDA de novo nod in Type 2 diabetes

Better days may have finally arrived for Better Therapeutics, after the company started this year with a swath of layoffs and sustained losses.

Better announced Monday afternoon that it received a long-awaited FDA clearance for its first digital therapeutic. Dubbed AspyreRx, the digital tool offers cognitive behavioral therapy to help people manage Type 2 diabetes.

The therapeutic specifically aims to “address the underlying factors that contribute to disease progression and achieve treatment outcomes beyond glucose management alone,” David Kerr, M.D., director of digital health at the Diabetes Technology Society, said in the announcement.

“The cornerstone of modern diabetes care is helping to improve self-efficacy, and AspyreRx now provides a prescription tool for physicians that seamlessly integrates with existing disease management programs to help patients make and sustain meaningful changes to improve their overall health,” Kerr continued.

Better submitted its digital therapeutic to the FDA for review last fall. But in February of this year, the agency asked the company to provide additional information about the technology—a request Better said it had responded to in mid-April, after which the FDA resumed its assessment.

AspyreRx landed a de novo authorization from the FDA based on the results of a study of more than 600 participants. Those assigned to use Better’s app demonstrated statistically significant improvements in their blood sugar levels over the course of several months compared to those who stayed within the current standard of care.

Those improvements lasted and even continued to grow between the three-month and six-month time points of the study. After the latter, about half of the AspyreRx users had achieved an average HbA1c reduction of 1.3 percentage points—with the study concluding that greater engagement with the app was linked to greater reductions in glucose levels.

The study also found that beyond blood sugar, the technology could help improve blood pressure, weight, mood, quality of life and other health and lifestyle factors.

With the FDA’s clearance now secured, Better said it will begin AspyreRx’s commercial launch in the fourth quarter of the year. The regulatory nod has also laid a “foundation” for the company’s technology to be translated into other applications, CEO Frank Karbe said in the announcement.

“Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our [prescription digital therapeutic] platform to multiple related conditions in the future,” Karbe said.

They include nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, or NAFLD and NASH, respectively. After the successful completion of a study of its digital tool to help treat those conditions, Better recently shared that it plans to apply for FDA breakthrough device designations in those indications.

The de novo nod comes after Better spent most of the last decade developing AspyreRx. That drawn-out process—during which the company wasn’t raking in any profits but pouring millions of dollars into developing the technology and waiting for the FDA’s green light—culminated in Better’s decision earlier this year to lay off more than a third of its workforce.

Approximately 35% of the company’s 54 employees were cut. The layoffs were announced in March, just a few days before Better published its full-year financial results for 2022, showing a net loss of just under $40 million—a number about equal to 2021’s tally.

More recently, in late June, Better disclosed in a filing with the U.S. Securities and Exchange Commission that it had received a notice from the Nasdaq warning the company that it was at risk of being delisted from the stock exchange after its shares failed to trade above $1 for 30 consecutive business days.

Better now has six months to regain compliance and seems to be on track to do so: Its stock has recently spent several days above the $1 threshold and jumped to $1.25—its highest point since April—Tuesday morning in the wake of the FDA clearance.