Better Therapeutics Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes
Pivotal trial established use of AspyreRx alongside standard of care demonstrating clinically meaningful and statistically significant reduction in HbA1c leading to FDA authorization
In a subgroup analysis, the use of AspyreRx and GLP-1 receptor agonists showed substantially greater A1c reductions than the previously reported results of the entire trial population
Recent draft guidance from the FDA indicates the intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions
In addition to improvements in HbA1c at day 90, participants that were on both GLP-1 medications and AspyreRx also showed greater HbA1c reduction, greater weight loss, and utilized fewer medications at day 180 when compared to participants on GLP-1 medications without AspyreRx. The data for this subgroup analysis are being submitted for peer-reviewed publication.
“The findings from this subgroup analysis support that patients receiving GLP-1 derive additional additive benefit from intensive behavioral modification provided by AspyreRx. Despite the important benefits of GLP-1 agents, patients receiving them may continue to struggle to achieve glycemic control for multiple reasons including therapeutic inertia and side-effects associated with these drugs. This new data underscores the importance of recognizing that behavior modification is a critical foundational component of diabetes treatment, including for patients taking GLP-1s. A comprehensive management approach that combines effective pharmacotherapy along with effective digital therapeutics to support patients in making and sustaining behavioral change appears to be an optimal approach to achieving treatment goals,” said
As previously reported, the BT-001 pivotal trial, the largest randomized controlled study ever conducted of a digital therapeutic to evaluate glycemic response in participants with T2D, met both its primary and secondary endpoints demonstrating statistically and clinically meaningful reductions in HbA1c over the control group receiving standard of care. The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that AspyreRx has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on blood sugar lowering medications.
In addition, exploratory data revealed a host of cardiometabolic improvements alongside reduced medication and healthcare utilization in comparison to the control group, supporting the potential for AspyreRx to improve the overall health of patients with T2D and potentially reduce increasingly costly interventions associated with the progression of the disease. A cost effectiveness analysis, which was part of a broader
The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled 'Regulatory Considerations for
"The FDA’s draft guidance opens up the possibility of expanding drug labeling to include the increased benefits patients may experience while also using PDTs. Strengthened drug labeling then has the potential to raise awareness about the concurrent benefits of drugs and PDTs, which enables providers to improve clinical outcomes. This differentiation may be particularly relevant within the highly competitive GLP-1 market. In this multi-billion-dollar category, PDTs like AspyreRx offer the chance to demonstrate added value by showing increased effectiveness of GLP-1 agents with a digital therapeutic," remarked
RCT Trial Design
The BT-001 pivotal trial was an open-label, randomized, controlled trial designed to evaluate the efficacy and safety of a digitally delivered CBT approach among a diverse, nationally representative group of patients with difficult to treat T2D. The trial was designed with a high bar to pass and to avoid artificial designs that could produce large outcomes that do not apply to all patients. This included using a “Standard of Care” comparison, as well as not constraining patients to a specific medication profile and not incentivizing patients to use the BT-001 therapy.
The clinical trial included a diverse, nationally representative patient population including participants from minority groups often underrepresented in diabetes studies. 40.2% of participants were non-white; 15.7% were Hispanic or Latin American. Participants had long-standing type 2 diabetes, high cardiovascular risk, multiple comorbidities with use of multiple medications.
AspyreRx (fka BT-001) was granted marketing authorization by the
Indications for Use
AspyreRx 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. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
For more information visit: bettertx.com
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’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx and CBT and their potential treatment applications and their ability to improve clinical outcomes, beliefs regarding the importance of behavior modification and comprehensive management approaches in diabetes treatment, statements related to recent draft guidance from the FDA and the potential of labeling to drive improved awareness of PDTs, among others. These forward-looking statements are based on the current expectations of the management of