Better Therapeutics has announced that it has received FDA authorisation for its prescription-only digital therapeutic (PDT) AspyreRx. The digital tool offers cognitive behavioural therapy to help people manage type 2 diabetes. 

Why it’s notable:

• The treatment is indicated to provide cognitive behavioural therapy to type 2 diabetes patients 18 years or older. AspyreRx provides an evidence-based intervention to support clinicians and people living with type 2 diabetes to address the underlying factors contributing to disease progression and improve treatment beyond glucose management alone, while integrating into existing disease management programs. In a study of more than 600 participants, the solution showed statistically significant improvements in blood sugar levels over several months when compared to those that stayed with the current standard of care. 

• Over almost a decade, Better Therapeutics has spent millions of dollars developing and awaiting FDA approval for AspyreRx, while not taking in any profit. In March, Better Therapeutics announced it was laying off approximately 35% of its staff, after publishing its 2022 financial report showing a net loss of just under $40M. The company is also at risk of being delisted from the stock exchange, following its failure to keep shares above $1 for 30 consecutive business days. Following this week's announcement, the company’s shares  were up nearly 49% to $1.34; however, this is still a fraction of the $10 pricing in 2021. 

Industry Implications: 

• Better Therapeutics PDT underwent review through the FDA de novo pathway. This has established the groundwork for the company’s technology to be translated into other therapeutic areas, a strategically important milestone as many cardiometabolic diseases such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis share underlying factors contributing to disease development and progression. Better Therapeutics has stated that it plans to apply for FDA approval for these indications, as well as having solutions for hypertension and high blood cholesterol in the pipeline. 

• There are 37 million people living with type 2 diabetes in the U.S. Despite the advancements in pharmacotherapy, a significant number of patients with type 2 diabetes continue to experience disease progression. The current treatment guidelines highlight the significance of lifestyle behaviour modifications as the fundamental approach for both preventing and managing the disease. However, the limitations associated with in-person therapy have hindered progress in assisting patients to adopt and maintain these behavioural changes consistently over time. AspyreRx has been developed to address these challenges, leveraging technology to deliver these interventions to patients with less reliance on in-person therapy. Furthermore involving HCP in the process adds another layer of oversight ensuring consistency across the patient’s treatment regimen. 

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