Better Therapeutics, Inc. announced top-line findings from a recent subgroup analysis of AspyreRx (formerly BT-001) in its pivotal trial for type 2 diabetes (T2D). The analysis reveals that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonists (GLP-1), leads to a substantially greater clinical improvement compared to control participants who did not incorporate AspyreRx into their regimen. A cost effectiveness analysis, which was part of a broader Health Economics and Outcomes Research (HEOR) 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The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled 'Regulatory Considerations for Prescription Drug Use-Related Software, released in September, which provides clarity about the agency's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. "The FDA's draft guidance opens up the possibility of expanding drug labeling to include the increased benefits patients may experience while also using PDTs.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 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; 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 U.S. Food and Drug Administration (FDA) in July 2023 as the first prescription-only digital behavioral therapeutic device delivering a novel form of cognitive behavioral therapy (CBT) via smartphone to treat adults with type 2 diabetes (T 2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in HbA1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions.

The forward-looking statements in this press release include, but are not limited to, statements regarding 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 involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics' business, such as the willingness of the FDA to authorize PDTs, for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including As pyreRx, the risk that the results of previously conducted studies will not be interpreted favorably by the FDA or repeated or observed in ongoing or future studies involving Better Therapeutics' business.