Authors conclude the totality of positive
efficacy, safety and usability data indicates the potential of
Better Therapeutics’ digitally delivered Cognitive Behavioral
Therapy to help address the significant unmet clinical needs
observed in MASLD and MASH
Company expects to submit request to the FDA
for Breakthrough Device Designation in Q4 2023
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing prescription digital therapeutics (PDTs) to treat
cardiometabolic diseases, today announced the pre-print publication
of the LivVita study's results in Gastro Hep Advances, a peer
reviewed journal produced by the American Gastroenterological
Association (AGA). 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 company anticipates submitting a
request to the FDA for Breakthrough Device Designation by the end
of 2023.
The study's authors conclude that the positive efficacy, safety,
and usability data underscore the potential of Better Therapeutics'
digitally delivered novel form of Cognitive Behavioral Therapy
(CBT) to address the significant unmet clinical needs associated
with metabolic dysfunction-associated steatotic liver disease
(MASLD) and metabolic dysfunction-associated steatohepatitis
(MASH), formerly known as NAFLD and NASH.
Growing rates of MASLD and MASH, linked to the increasing
prevalence of obesity and diabetes, pose pressing public health
concerns. Despite their impact and prevalence, there are currently
no FDA approved treatments. Standard of care guidelines emphasize
the importance of lifestyle changes in the management of these
conditions, yet implementing behavior change counseling in clinical
practice remains challenging due to provider constraints and
patient difficulties in translating recommendations into
sustainable new behaviors without adequate support.
The LivVita study evaluated Better Therapeutics’ novel CBT
platform that targets individuals’ thoughts and beliefs related to
improving healthy behaviors, such as diet and physical activity.
Over the course of 90 days, the investigational treatment was
delivered to participants without requiring additional intervention
from healthcare providers.
"Behavior change has long been recognized as a means to slow or
halt disease progression, but delivering scalable patient support
has remained a challenge,” said Naim Alkhouri, MD, Director of the
Fatty Liver Program at Arizona Liver Health and Principal
Investigator of the study. “The reduction in liver fat and enzymes
observed with this digital therapy within a short time frame is
promising and, if authorized, has the potential to revolutionize
the treatment of MASLD and MASH by providing a practical tool we
can prescribe to help patients living with these chronic
conditions.”
This first-of-kind study demonstrated improvements in multiple
markers, including MRI-PDFF, FibroScan CAP score, weight, FastTM
score, and ALT, suggesting therapeutic potential in a larger
patient population. Additionally, there were no device-related
adverse events, even in patients with a large number of
comorbidities and background pharmacotherapy use.
Mazen Noureddin, a scientific advisor to the study, noted, "The
positive signals in this pilot study across multiple disease
biomarkers established a proof-of-concept for this prescription
digital therapy platform to potentially offer a new option for the
treatment of MASLD and MASH and could help to address the
significant unmet clinical and public health needs by providing
scalable, accessible, and effective behavioral therapy.
Better Therapeutics' novel CBT platform has already demonstrated
clinically meaningful outcomes in type 2 diabetes (T2D),
hypertension, and hyperlipidemia. A randomized controlled pivotal
trial demonstrated clinically meaningful and sustained reduction in
HbA1c as well as improvements in other markers of cardiometabolic
health when used up to 180 days, leading to FDA authorization of
AspyreRx as the first prescription-only digital behavioral
therapeutic delivering a novel form of CBT via smartphone to treat
adults with T2D. AspyreRx is expected to launch commercially in Q4
2023.
Mark Berman, MD, Chief Medical Officer at Better Therapeutics,
concluded, "As we witness the transformative impact of digital
therapeutics on conditions like type 2 diabetes, MASLD and MASH, we
envision a future where PDTs not only serve as first-line
treatments, but also complement pharmacotherapy, empowering
patients to achieve treatment goals and enhance their quality of
life."
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’ PDT 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
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’ plans related to the potential
commercial launch of AspyreRx (formerly BT-001) for the treatment
of T2D, expectations related to the efficacy and potential benefits
of PDTs and CBT and their potential treatment applications,
including in MASLD and MASH, Better Therapeutics’ plans regarding
its request to the FDA for Breakthrough Device Designation and
Better Therapeutics’ expectations regarding the data from the
LivVita Study, 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 quarter ended June 30, 2023
filed with the Securities and Exchange Commission (SEC) on August
9, 2023, and those that are included in any of Better Therapeutics’
subsequent filings with the SEC.
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version on businesswire.com: https://www.businesswire.com/news/home/20231005578596/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams info@bettertx.com
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