Tuesday, July 11, 2023
Better Therapeutics, a renowned developer of software solutions for cardiometabolic diseases, has announced that the Food and Drug Administration (FDA) has granted approval for AspyreRx™ (formerly known as BT-001). This groundbreaking prescription-only digital therapeutic aims to provide cognitive behavioral therapy to individuals aged 18 and above who have been diagnosed with type 2 diabetes (T2D). AspyreRx underwent an extensive review process through the FDA's De Novo pathway, resulting in the establishment of a new category of diabetes digital behavioral therapeutic devices. The commercial launch of AspyreRx is anticipated in the fourth quarter of 2023.
As per David Kerr MBChB, DM, FRCP, FRCPE, Director of Digital Health at the Diabetes Technology Society, AspyreRx is a revolutionary intervention that provides clinicians and individuals with type 2 diabetes (T2D) an evidence-based approach to address the underlying factors contributing to disease progression. It goes beyond managing glucose levels alone and helps patients achieve treatment outcomes by improving self-efficacy. The integration of AspyreRx into existing disease management programs seamlessly provides physicians with a prescription tool to assist patients in making sustainable changes for overall health improvement.
Frank Karbe, Chief Executive Officer at Better Therapeutics, emphasizes the significant impact of AspyreRx's regulatory milestone. It marks a promising future where technology, psychology, and medicine converge to tackle the behavioral causes of disease in the 37 million T2D patients in the U.S. This De Novo authorization lays the foundation for potential future growth opportunities. As cardiometabolic diseases share common underlying factors contributing to their development and progression, the intention is to expand the Prescription Digital Therapeutic (PDT) platform to encompass multiple related conditions.
The marketing authorization for AspyreRx was granted based on the efficacy and safety data derived from a randomized controlled trial involving 668 participants, leading to clinically meaningful results that were published in Diabetes Care.
Summary of Clinical Trial Results:
• The trial successfully met its primary (p<0.0001) and secondary (p=0.01) endpoints, demonstrating statistically significant reductions in HbA1c levels compared to a control group receiving standard care and a control app. The results remained sustained and even improved between day 90 and day 180 of the trial, indicating the potential of AspyreRx to deliver meaningful and durable reductions in blood sugar for a diverse range of T2D patients.
• Approximately half of the participants achieved a mean reduction of 1.3% in A1c levels after 180 days of using AspyreRx.
• On average, subjects who used AspyreRx experienced various positive cardiometabolic improvements, including improved fasting blood glucose, reduced systolic blood pressure, weight reduction, improved mood, enhanced quality of life scores, lower medication utilization, and fewer diabetes-related risks compared to non-users.
• The trial revealed a clear dose-response relationship, supporting cognitive behavioral therapy (CBT) as a mechanism of action to generate positive clinical outcomes, with greater engagement in CBT leading to greater reductions in HbA1c levels.
• Patient engagement and adherence were excellent, with 94% of participants using the intervention at day 90 and 81% remaining engaged at day 180.
Despite advancements in pharmacotherapy, many T2D patients continue to experience disease progression. While lifestyle behavior change is emphasized as a cornerstone in preventing and treating the disease, delivering in-person therapy poses limitations in helping patients make and sustain behavioral changes in a standardized, convenient, and scalable manner. AspyreRx addresses these barriers by utilizing technology to deliver an evidence-based therapeutic intervention to patients. The involvement of healthcare providers ensures seamless coordination between AspyreRx and other aspects of treatment, adding an important layer of expertise and oversight.
Dr. Mark Berman, Chief Medical Officer at Better Therapeutics, expressed gratitude towards the patients who used their platform and the clinicians who guided them throughout the eight-year development process. He stated that they are immensely proud of this milestone and firmly believe that AspyreRx holds the potential to enhance access to care for a diverse patient population, empowering individuals to live healthier lives.