Better Therapeutics Announces Submission for FDA Breakthrough Device Designation for Digital Therapeutic Platform to Treat Liver Disease
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From a medical research perspective, the submission for Breakthrough Device Designation by Better Therapeutics represents a significant step in the management of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). Given the prevalence of these conditions, particularly among populations with type 2 diabetes and obesity, the potential market for such a digital therapeutic is substantial. The successful LivVita Liver Study, which met its primary endpoint, underscores the efficacy of digital cognitive behavioral therapy (CBT) in reducing liver fat and improving liver health within a short period. The scalability and cost-effectiveness of PDTs could revolutionize the treatment paradigm for MASLD and MASH, which currently lack FDA-approved treatments.
Moreover, the digital format of the therapy addresses systemic accessibility barriers, presenting a solution to the current gap in patient care. The absence of device-related adverse events in the study is also noteworthy, as it suggests a favorable safety profile. The potential FDA Breakthrough Device Designation could expedite the review process, thereby bringing the PDT to market more quickly and possibly establishing a new standard of care for patients with these liver conditions.
The economic implications of Better Therapeutics' PDT for MASLD and MASH are multifaceted. On one hand, the digital therapeutic platform offers a cost-effective alternative to traditional in-person behavioral therapy, which could lead to significant savings for healthcare systems burdened by the high costs associated with managing cardiometabolic diseases. On the other hand, the lack of FDA-approved treatments for these conditions to date implies a first-mover advantage for Better Therapeutics, should their PDT receive the designation and subsequent approval.
The potential for PDTs to reduce the need for more expensive interventions, such as liver transplants, by managing the disease progression more effectively, could also have a substantial impact on healthcare expenditure. However, the company's financial health, with a decrease in cash and cash equivalents from $6.6 million to $4.2 million within a fiscal quarter, raises questions about their capacity to sustain the development and potential market launch of this PDT without additional funding or partnerships.
As a market research analyst, it's important to assess the competitive landscape and the potential market size for Better Therapeutics' PDT. The MASLD and MASH market is currently underserved with no FDA-approved drug or device treatments, presenting a significant opportunity for Better Therapeutics. The digital nature of their product allows for rapid scalability and could lead to widespread adoption if proven effective and safe.
However, the company's current financial position indicates a need for careful strategic planning to ensure successful commercialization. Market penetration will depend not only on FDA approval but also on reimbursement strategies, partnerships and patient and provider acceptance of digital therapeutics as a valid treatment option. The breakthrough designation, if granted, would likely have a positive impact on the company's stock value, as it would signal confidence in the product's potential and expedite its path to market. It is essential to monitor the FDA's response and subsequent market dynamics closely.
MASLD affects an estimated
Behavioral modification is the recommended first-line treatment in clinical practice guidelines to help address many of the root causes and cardiometabolic comorbidities associated with MASLD and MASH. However, systemic accessibility barriers to in-person behavioral therapy exist, preventing a significant number of patients from receiving the care they need. PDTs offer the potential to address the growing need for a clinical tool that healthcare providers can offer patients living with these conditions.
This regulatory step for Better Therapeutics follows the completion of the Company’s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. The study successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device related adverse events. The study’s authors concluded the totality of positive efficacy, safety and usability data indicates the potential of Better Therapeutics’ digitally delivered CBT to help address the significant unmet clinical needs observed in MASLD and MASH.
“As a physician dedicated to addressing the complexities of metabolic disorders, witnessing the reduction in liver fat and enzymes within a short timeframe through this digital therapy is not only promising, but represents a groundbreaking advancement to use technology to help facilitate evidence-based treatment,” said Naim Alkhouri, MD, Director of the Fatty Liver Program at Arizona Liver Health and Principal Investigator of the study. “This innovation has the potential to offer effective and scalable support that can make a meaningful impact on those living with MASLD and MASH.”
The FDA’s Breakthrough Device Designation is designed to expedite the development, assessment, and review of devices that demonstrate the potential to address life-threatening or irreversibly debilitating conditions where no approved or cleared alternative treatment options exist. The expected response timeline from the FDA is 60 days after receipt of a Breakthrough Device Designation application.
“Securing Breakthrough Device Designation from the FDA has the potential to accelerate the expansion of our digital therapeutics platform beyond type 2 diabetes,” said Frank Karbe, President and CEO at Better Therapeutics. “The versatility of our therapeutic approach across a broad spectrum of cardiometabolic conditions is an exciting and unique aspect of our platform. Furthermore, the digital nature of our products allows for potential expansion in a fraction of the time and cost compared to traditional drug development.”
Better Therapeutics ended its fiscal year 2023 with cash and cash equivalents of
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy 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 CBT delivered by Better Therapeutics’ PDTs 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.
For more information visit: bettertx.com
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 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 to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.
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.
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, expectations regarding the amendment to the Hercules debt facility and the outcome and success of cost saving initiatives, including salary reductions, and operational plans and their impact on Better Therapeutics’ financial position and cash runway, and expectations regarding the commercial traction of AspyreRx and partnering discussions, 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 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 AspyreRx, 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’ product candidates 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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Investor Relations and Media Enquiries:
Emma Williams
info@bettertx.com
Source: Better Therapeutics, Inc.
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