The Better Therapeutics Inc (NASDAQ: BTTX) stock price rallied 32.2% after announcing that it had received authorisation from the US Food and Drug Administration (FDA) for the marketing of AspyreRx™, a prescription-only digital therapeutic (PDT) treatment for type 2 diabetes (T2D).
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AspyreRx™ was formerly known as BT-001 and is a treatment that provides cognitive behavioral therapy to patients 18 years or older with T2D. AspyreRx was reviewed through the FDA’s De Novo pathway, and its authorization creates a new class of diabetes digital behavioral therapeutic devices.
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Better Therapeutics intends to launch AspyreRx in Q4 2023. 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.
AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results published in Diabetes Care.
The trial met its primary (p<0.0001) and secondary (p=0.01) endpoints showing statistically significant decreases in HbA1c levels when compared to a control group receiving standard of care and a control app. The results were sustained and improved between day 90 and day 180 of the trial.
David Kerr MBChB, Director of Digital Health at the Diabetes Technology Society, said: “AspyreRx is a game-changer as we now have an evidence-based intervention to help clinicians and people living with type 2 diabetes address the underlying factors that contribute to disease progression and achieve treatment outcomes beyond glucose management alone.”
Frank Karbe, the Better Therapeutics CEO, said: “This regulatory milestone signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioral causes of disease for the 37 million patients living with T2D in the U.S.”
“This De Novo authorization also provides a foundation for potential future growth opportunities. Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our PDT platform to multiple related conditions in the future.”
*This is not investment advice.
The Better Therapeutics (BTTX) stock price.
The Better Therapeutics (BTTX) stock price rallied 32.22% to trade at $1.19, from Monday’s closing price of $0.90.
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