FDA Approves Better Therapeutics’ Mobile App as Treatment for Type 2 Diabetes

The FDA has authorized a mobile app called AspyreRx, developed by Better Therapeutics, as a treatment for type 2 diabetes. This regulatory decision creates a new class of therapies for the metabolic disorder. AspyreRx is a prescription digital therapeutic that digitizes cognitive behavioral therapy, which is already part of diabetes care. The app allows patients to have an interactive experience and personalized treatment plan via their mobile devices. The FDA reviewed AspyreRx under the De Novo pathway for novel medical devices and based its authorization on the results of a pivotal study that demonstrated a reduction in hemoglobin A1c (HbA1c) levels in patients with uncontrolled type 2 diabetes.
Better reported that the results of using AspyreRx after 90 days of treatment were sustained and even improved after 180 days. The company also noted improvements in other cardiometabolic measures such as fasting blood glucose, blood pressure, and weight. Better’s CEO, Frank Karbe, sees this regulatory decision as a sign of a future where technology, psychology, and medicine converge. He also sees potential for future growth opportunities, as cardiometabolic diseases share common underlying factors.
Better has a pipeline of other digital therapeutics in development, including ones for non-alcoholic steatohepatitis, hypertension, and hyperlipidemia. However, the company has limited resources to advance these projects while also focusing on the commercialization of AspyreRx. In March, Better announced layoffs of about 35% of its workforce to extend its cash runway. Cash could be a problem for the company, as it reported a cash position of $6 million at the end of the first quarter of this year. It completed a private placement in April to add another $6.5 million in funds. There may be challenges in raising more capital through a stock offering, as the Nasdaq warned Better of potential delisting due to its stock price falling below $1 per share.
Despite these challenges, the FDA authorization of AspyreRx has had a positive impact on Better’s stock price, boosting it above the $1 mark. Better plans to launch AspyreRx, its first product, in the fourth quarter of this year. The company also intends to expand its prescription digital therapeutics platform to other related conditions in the future.