One million prescriptions for AspyreRx will be offered to patients in underserved communities disproportionately affected by type 2 diabetes

SAN FRANCISCO--(BUSINESS WIRE)--Mar. 5, 2024-- Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced a major partnership with the American College of Lifestyle Medicine's (ACLM) National Training Initiative (NTI), aimed at improving diabetes outcomes in underserved communities across the United States. Through this partnership, Better Therapeutics is committed to making one million prescriptions of its U.S. Food and Drug Administration (FDA)-authorized product, AspyreRx, available to support underserved patients through 1,400 Federally Qualified Health Center (FQHC) organizations.

Diabetes disproportionately impacts underserved communities, driven by socioeconomic disparities, inadequate healthcare access, and systemic injustices. Despite advancements in pharmacotherapy with GLP-1s and the increase in availability of innovative devices like continuous glucose monitors, diabetes prevalence continues to rise, and only about 50% of adults with diabetes achieve glycemic control. This underscores the urgent need for evidence-based interventions to ensure equitable access to high-quality care for all.

Lifestyle medicine is a medical specialty that uses therapeutic lifestyle interventions to treat chronic conditions, including cardiovascular diseases, type 2 diabetes, and obesity, and, when used intensively, can often reverse such conditions.

The Lifestyle Medicine National Training Initiative (NTI) is an extension of ACLM's $24.1 million commitment to the 2022 White House Conference on Hunger, Health, and Nutrition. It commits more than $2 million in matching funds to train primary care providers in lifestyle medicine within each FQHC and Community Health Center (CHC) across the United States. AspyreRx complements this important initiative by helping to ensure that a scalable, lifestyle medicine digital therapeutic is broadly accessible, regardless of socioeconomic status or geographic location.

"This innovative partnership demonstrates our joint commitment to addressing disparities in healthcare access and promoting the adoption of lifestyle medicine clinician training coupled with evidence-based treatments," said Mark Berman, MD, FACLM, chief medical officer at Better Therapeutics. "With our robust clinical data including strong representation from these underserved communities, we're uniquely positioned to showcase the transformative potential of software-based interventions, offering more efficient and effective treatments compared to current behavioral programs. By scaling up, we can break down barriers to care and drive significant health outcomes in often neglected communities."

AspyreRx is the only FDA-authorized, fully digital, and therefore easily accessible and scalable, lifestyle intervention designed to improve type 2 diabetes (T2D) outcomes. It is backed by robust data from a randomized controlled trial (RCT) demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. The RCT established new benchmarks for inclusivity by actively involving participants from these underserved communities. Baseline characteristics included strong representation of different races and ethnicities (40% non-white), as well as diversity in socioeconomic status and levels of education, with 98% living in low-income or medium-income neighborhoods.

"We're thrilled that ACLM's commitment in support of the White House Challenge to End Hunger and Build Healthy Communities inspired Better Therapeutics to join us in addressing lifestyle-related chronic disease health disparities," remarked Beth Frates, MD, FACLM, DipABLM, president of ACLM and Harvard Medical School faculty member. "By advancing lifestyle medicine training and increasing awareness of evidence-based treatments that help patients make and sustain behavioral changes, our joint efforts aim to empower individuals to understand the healing power of using food and lifestyle as medicine, ultimately reducing the burden of chronic illness in communities nationwide."

Starting in the second quarter of 2024, FQHC clinicians will have the opportunity to recommend AspyreRx to reinforce and advance healthful lifestyle behaviors, empowering patients to take greater control of their health destinies. The AspyreRx implementation is expected to run for two years. Better Therapeutics and ACLM are seeking additional partners and funding to support the implementation and maximize the initiative's impact.

"In forging this alliance, we expect to accelerate the adoption of AspyreRx and deliver on our vision of making societies healthier and meaningfully reducing healthcare costs, while at the same time significantly enhancing the impact of ACLM's National Training Initiative," emphasized Frank Karbe, president, and chief executive officer at Better Therapeutics. "Expanding access to underserved diabetes patients complements our commercial strategy, since the increase in providers gaining experience with our product as well as the generation of real-world data will support coverage discussions with insurers and allow us to further enhance the patient experience."

About Better Therapeutics

Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The treatment is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics' clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.

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About the American College of Lifestyle Medicine

The American College of Lifestyle Medicine is the nation's medical professional society advancing lifestyle medicine as the foundation for a redesigned, value-based, and equitable healthcare delivery system, leading to whole-person health. ACLM educates, equips, empowers and supports its members through quality, evidence-based education, certification and research to identify and eradicate the root cause of chronic disease, with a clinical outcome goal of health restoration as opposed to disease management.

About AspyreRx

AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used for up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access from their smartphone. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior step to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.

Forward-Looking Statements

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, and expectations regarding the commercial traction of AspyreRx, among others. These forward-looking statements are based on the current expectations of the management of Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. 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 commercial distribution, market acceptance and insurance reimbursement of AspyreRx; Better Therapeutics' ability to raise capital in the near term to fund its operations and continue as a going concern; Better Therapeutics' need to seek strategic alternatives in the event the company is unable to raise capital, including, without limitation, potential sale of its assets or business, assignment for the benefit of creditors or wind-down of the company; Better Therapeutics' ability to comply with ongoing covenants under its Hercules Capital debt facility (including the minimum cash covenant) and potential default and foreclosure under the debt facility; the outcome of Better Therapeutics' delisting hearing with Nasdaq appeals panel and potential delisting from the Nasdaq Capital Market, and other risks and uncertainties included under the header "Risk Factors" in Better Therapeutics' quarterly report on Form-10-Q for the fiscal quarter ended September 30, 2023 filed with the Securities and Exchange Commission ("SEC") on November 09, 2023, and those that are included in any of the Company's subsequent filings with the SEC.

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Source: Better Therapeutics, Inc.