Better Therapeutics announces topline findings from AspyreRx analysis

Better Therapeutics announced top-line findings from a recent subgroup analysis of AspyreRx in its pivotal trial for type 2 diabetes, or T2D. The analysis reveals that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonists, leads to a substantially greater clinical improvement compared to control participants who did not incorporate AspyreRx into their regimen. The subgroup analysis, involving approximately 160 participants on GLP-1s randomized to the active and control arm of the study, exhibited an average reduction in HbA1c of 0.7% at 90 days, between the two groups. This exceeds the results of the entire BT-001 pivotal trial population, where AspyreRx outperformed the standard of care control arm by 0.4%. Both reductions were statistically significant when compared to the corresponding control group. 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. 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 Health Economics and Outcomes Research conducted by Better Therapeutics, indicates that the utilization of AspyreRx may not only be more effective than standard of care alone but may also be less costly for payers. The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled ‘Regulatory Considerations for Prescription Drug Use-Related Software,’ released in September, which provides clarity about the agency’s views and intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions.