A Better Therapeutics mobile app that digitizes cognitive behavioral therapy is now authorized by the FDA as a treatment for type to 2 diabetes, a regulatory decision that creates a new class of therapies for the metabolic disorder.
The regulatory decision covers type 2 diabetes patients age 18 and older. The prescription digital therapeutic, known in development as BT-001, will be commercialized under the brand name AspyreRx. Better expects to launch the product, its first, in the fourth quarter of this year.
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Cognitive behavioral therapy is already part of diabetes care. Patients meet one-on-one with a clinician in sessions that guide them to change behaviors and alter the course of their disease. AspyreRx puts this interactive experience in the hands of the patient via a mobile app. The software uses artificial intelligence to personalize each patient’s treatment plan.
The FDA reviewed AspyreRx under the De Novo pathway for novel medical devices. FDA authorization of the Better product is based on the results of a pivotal study that enrolled 669 patients with uncontrolled type 2 diabetes. The open-label study compared the Better app and standard of care to standard of care alone. The main goal was to show a reduction in hemoglobin A1c (HbA1c), a biological indicator of blood sugar levels. After 90 days, results showed a statistically significant reduction in HbA1c in the treatment group compared to the control arm. These data were published last December in the journal Diabetes Care.
Better reported that the results after 90 days of treatment with AspyreRx were sustained and even improved when measured at 180 days. The company also noted improvements on other cardiometabolic measures, such as fasting blood glucose, blood pressure, and weight. In a prepared statement, Better CEO Frank Karbe said the regulatory decision signals a future where technology, psychology, and medicine converge.
“This De Novo authorization also provides a foundation for potential future growth opportunities,” he said. “Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our [prescription digital therapeutics] platform to multiple related conditions in the future.”
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The Better pipeline includes BT-002 for the fatty liver disease non-alcoholic steatohepatitis, or NASH; BT-003 for hypertension; and BT-004 for hyperlipidimia. All three are in pilot testing, but Better has limited resources to advance them while also focusing on AspreRx’s commercialization. In March, Better announced the layoff of about 35% of its workforce to extend the company’s cash runway. According to Better’s 2022 annual report, the company’s headcount was 54 at the end of 2022, including three in sales and marketing.
Cash could be a problem for Better as it looks ahead to commercialization of AspyreRx. As of the end of the first quarter of this year, Better reported a cash position of $6 million. In April, the company completed a private placement that added another $6.5 million. It could be tough to raise more capital through a stock offering. Last month, the Nasdaq warned Better that its stock faced delisting for failing to maintain a price of at least $1 per share. However, news of AspyreRx’s FDA authorization boosted Better shares above that price mark on Tuesday morning.
Photo: diego_cervo, Getty Images
