First Study of Nutritional Cognitive Behavioral
Therapy for Fatty Liver Disease and Expanded Real-World Evidence
Studies for Type 2 Diabetes Follow Promising Primary Endpoint
Clinical Trial Data
Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital
therapeutics (PDT) company developing nutritional cognitive
behavioral therapy (nCBT) to address the root causes of
cardiometabolic diseases, today announced several key research
milestones designed to advance and further validate its therapeutic
technologies, including the first ever study of nCBT as potential
treatment for Nonalcoholic Fatty Liver Disease (NAFLD) and
Nonalcoholic Steatohepatitis (NASH). This announcement arrives on
the heels of positive primary endpoint data from the pivotal
clinical trial of BT-001, the company’s prescription digital
therapeutic for type 2 diabetes.
Better Therapeutics digital therapeutic platform delivers a
novel form of cognitive behavioral therapy to help people with
cardiometabolic diseases potentially improve key measures related
to type 2 diabetes, NAFLD, NASH, hypertension, hyperlipidemia and
other cardiometabolic conditions. By adapting the principles and
mechanisms of cognitive behavioral therapy, the digital therapeutic
platform is designed to address and modify the cognitive patterns
that drive eating habits and other behavioral factors associated
with cardiometabolic diseases.
Better Therapeutics + Arizona Liver Health LivVita
Study
Conducted in collaboration with Arizona Liver Health, a leading
liver clinical research center, Better Therapeutics has commenced
the LivVita study designed to evaluate the feasibility of its nCBT
platform to reduce liver fat and improve liver disease biomarkers
in NAFLD and NASH, and enrolled its first patients.
“With a quarter of American adults affected by NAFLD, including
70% of diabetes patients, fatty liver disease is a growing public
health crisis made even more challenging by a lack of effective,
FDA-approved therapeutics,” said Mazen Noureddin, MD, director of
Cedars Sinai Fatty Liver Program and who serves as the senior
clinical advisor for the LivVita study. “We are hopeful that the
nCBT approach offered by Better Therapeutics can prove effective in
treating this condition and alleviating the pressure it places on
our health system, including the $100 billion annual cost incurred
as a direct result of this condition.”
Better Therapeutics + Mass General Brigham BT-001 Real-World
Evidence Study
Additionally, Better Therapeutics announced that it has expanded
its real-world evidence study of BT-001, now including Mass General
Brigham, and has begun enrolling patients with type 2 diabetes.
“The Digital Care Transformation program at Mass General Brigham
is an ideal setting to evaluate BT-001’s long-term durability of
effect and cost of care impact in a diverse population treated in a
remote, real-world clinical setting,” said Benjamin Scirica, MD,
MPH, director of quality initiatives at the cardiovascular division
of Mass General Brigham. “We see great potential for a prescription
digital therapeutic like BT-001, and how the patient data generated
during the course of use could inform and improve the delivery and
quality of care we provide our patients.”
This study follows Better Therapeutics’ release of primary
endpoint data for BT-001 which demonstrated statistically
significant and clinically meaningful reductions in A1c, a measure
of blood sugar. After 90 days of treatment, 61% of patients lowered
A1c (a measure of blood sugar); 43% reduced A1c by 0.4% or greater
(mean 1.1%), while only 25% of the control group achieved the same
reduction. The result was highly statistically significant with a p
value of < .00001.
Better Therapeutics + Durham Veterans Administration BT-001
Real-World Evidence Study
Better Therapeutics also announced that the Durham Veterans
Administration Medical Center has joined its real-world evidence
study held in collaboration with the Colorado Prevention
Center.
“Demonstrating the potential to improve and maintain glycemic
control and reduce ongoing healthcare costs and medications within
the veteran community is of critical importance,” said Mark Berman,
MD, chief medical officer of Better Therapeutics. “Veterans suffer
disproportionately from type 2 diabetes, which is the largest
driver of costs within the VA.”
Studies like this are critical not only to the development of
BT-001, but to establish the effectiveness of nCBT delivered by
prescription digital therapeutics as a critical tool in the fight
against cardiometabolic diseases.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT)
company developing a novel form of cognitive behavioral therapy to
address the root causes of cardiometabolic diseases. The company
has developed a proprietary platform for the development of
FDA-regulated, software-based solutions for type 2 diabetes, heart
disease and other conditions. The cognitive behavioral therapy
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 the timing and results of the ongoing trial of BT-001 in
patients with type 2 diabetes, Better Therapeutics’ plans regarding
FDA submissions, expectations related to the potential benefits of
BT-001 and CBT and their potential treatment applications, Better
Therapeutics’ plans regarding the research and advancement of its
product candidates for additional treatments, expectations related
to the interest of healthcare providers and payers in PDTs and
legislative developments affecting PDTs and the outcome of such
developments, 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, the risk that
the results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our product
candidates and other risks and uncertainties included under the
header “Risk Factors” in the definitive proxy statement/prospectus
filed by us on October 12, 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20220406005103/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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