Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes
First prescription digital behavioral therapeutic device delivering novel form of cognitive behavioral therapy via smartphone
In a randomized controlled trial AspyreRx demonstrated clinically meaningful and statistically significant durable reductions in A1c
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"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,” 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.,” said
AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results, which were published in Diabetes Care.
Summary of Clinical Trial Results
- 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, demonstrating that BT-001 has the potential to deliver meaningful, durable reductions in blood sugar for a complex range of patients with T2D.
- 1 in 2 people achieved a mean A1c reduction of 1.3% after 180 days of use.
- On average, subjects who used BT-001 also experienced a host of cardiometabolic improvements including improved fasting blood glucose, reduced systolic blood pressure, reduced weight, improved mood, improved quality of life scores, lower medication utilization and fewer diabetes related risks compared to subjects who did not use BT-001.
- A clear dose-response between greater engagement in CBT and greater reductions in HbA1c was found, supporting CBT as a mechanism of action to generate positive clinical outcomes.
- Patient engagement and adherence was excellent with 94% of the participants using the intervention at day 90 and 81% still engaged at day 180.
The majority of patients with T2D progress in their disease, despite advances in pharmacotherapy. Treatment guidelines emphasize lifestyle behavior change as the cornerstone in the prevention and treatment of disease; however, given the constraints of delivering in-person therapy there has been limited advancement in helping patients make and sustain behavior change in a way that is standardized, convenient and scalable. AspyreRx is designed to address these barriers, leveraging technology to deliver an evidence-based therapeutic intervention to patients. The involvement of healthcare providers adds an important layer of expertise and oversight, ensuring seamless coordination between AspyreRx and other aspects of treatment.
“Our team has dedicated eight years to developing this treatment and we are grateful for the thousands of patients who have used our platform and for the many clinicians who have guided us to this point,” said
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About Type 2 Diabetes
Type 2 diabetes (T2D) is a widespread chronic disease in the
About AspyreRx
AspyreRx (formerly BT-001) is Better Therapeutics’ clinically validated prescription digital therapy for the treatment of T2D. Using proven techniques that target the underlying psychological, behavioral and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access anytime/anywhere. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes. AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in HbA1c when used up to 180 days.
Indications for Use
BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
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Forward-Looking Statements
Certain statements made in this press release are "forward-looking statements" within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding Better Therapeutics’ plans and expectations regarding FDA submissions, plans related to the potential commercial launch of AspyreRx (formerly BT-001) for the treatment of T2D, expectations related to the efficacy and potential benefits of BT-001 and CBT and their potential treatment applications, the potential of AspyreRx to address barriers and enhance access to care, Better Therapeutics’ plans regarding the research and advancement of its product candidates for additional treatments, expectations related to pricing research and results and the interest of healthcare providers and payers in PDTs, Better Therapeutics’ plans regarding publications, and statements related to its long-term plans and expectations, among others. These forward-looking statements are based on the current expectations of the management of
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