ADA-published, peer-reviewed journal article
highlights positive primary endpoint data from trial evaluating
digitally delivered approach to diabetes management
Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital
therapeutics (PDT) company developing a novel form of cognitive
behavioral therapy (CBT) to address the root causes of
cardiometabolic diseases, today announced that the positive 90 day
results from its pivotal trial for BT-001, a potentially
first-of-its-kind digital therapeutic platform that is designed to
use CBT to treat type 2 diabetes (T2D) in patients 18 years and
older, have been published in the American Diabetes Association
(ADA)-produced, peer reviewed journal Diabetes Care.
The article published in the latest edition of Diabetes Care
details data from the first 90 days of the pivotal trial, which
looked at a group of adults with T2D receiving the current standard
of care randomized to BT-001 or a control group. This trial was the
largest randomized, controlled study conducted to date looking at
use of digitally delivered CBT to improve glycemic control in T2D.
Patients using BT-001 saw A1c lowered on average by 0.4% compared
to the control group after 90 days, with a greater reduction among
patients who completed more modules of the therapy. The article
concludes that “delivery of a cognitive behavioral intervention via
smartphone app can provide a scalable option for improving glycemic
control.”
In addition to publication in Diabetes Care, the pivotal trial
results were recently presented on October 1, 2022 by Dr. Marc
Bonaca, Professor of Medicine at the University of Colorado School
of Medicine and Executive Director of CPC Clinical Research as part
of the Society for Vascular Medicine’s Annual Scientific
Sessions.
“When we saw the complete results from this trial at both the
90- and 180-day endpoints, we were encouraged by the real and
tangible potential of using our investigational,
digitally-delivered CBT to help people with type 2 diabetes gain
more control over their condition,” said Dr. Mark Berman, Chief
Medical Officer of Better Therapeutics. “We are excited for this
data to be featured in such a well-regarded and widely-cited
publication as Diabetes Care.”
The results featured in Diabetes Care – as well as the topline
180-day results announced earlier this summer – helped support the
recent submission of a de novo classification request for BT-001 to
the U.S. Food and Drug Administration (FDA), which, if authorized,
would make BT-001 the first prescription digital therapeutic
delivering CBT available for adults with T2D. The pivotal trial
data showed that patients using BT-001 saw encouraging improvement
over the current standard of care, with significant and durable A1c
reductions at both 90 and 180 days. Exploratory data revealed
cardiometabolic improvements as well as lower medication
utilization compared to the control group.
“When it comes to cardiometabolic diseases like type 2 diabetes,
available treatments have been focused on improving biomarkers
alone, like glucose, rather than helping to address the underlying
behaviors which lead to the onset and inevitable progression of
disease,” said Dr. Marc P. Bonaca, a Cardiologist and Vascular
Medicine Specialist at the University of Colorado School of
Medicine and Executive Director of CPC Clinical Research and CPC
Community Health, the senior author on the journal article. “While
both are important, the foundation of treatment must include
effective interventions for behavioral change. We are encouraged
that digital solutions like BT-001 have the potential to be
prescribed to help patients make sustainable changes that improve
A1c and may also improve health outcomes, slow the progression of
their disease and decrease the long-term cost of care.”
About BT-001
BT-001 is Better Therapeutics’ investigational prescription
digital therapy for the treatment of T2D. The investigational
therapy is delivered via software that provides a tailored
experience to patients designed to help them address the underlying
causes of T2D by making meaningful, sustainable behavioral changes.
The BT-001 investigational therapy is rooted in the well-studied,
gold standard of behavioral modification therapies, cognitive
behavioral therapy (CBT). While in-person CBT has been used for T2D
and other cardiometabolic conditions before, until now the approach
has not been scalable due to the need to deliver the therapy via a
therapist. If authorized by FDA, BT-001 would be the first
validated, prescription solution for delivering this therapeutic
approach to T2D patients at scale, from their digital devices.
About the Better Therapeutics CBT Platform
Better Therapeutics’ investigational digital therapeutic
platform is designed to deliver a novel form of CBT to help people
with cardiometabolic diseases potentially improve key measures
related to T2D, nonalcoholic fatty liver disease, nonalcoholic
steatohepatitis, hypertension, hyperlipidemia and other
cardiometabolic conditions. By adapting the principles and
mechanisms of CBT, the digital therapeutic platform is designed to
address and modify the cognitive patterns that affect eating habits
and other behavioral factors associated with cardiometabolic
diseases.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT)
company developing a novel form of cognitive behavioral therapy
(CBT) 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 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, if authorized for marketing, 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 results of the completed trial of BT-001 in patients
with type 2 diabetes, Better Therapeutics’ plans and expectations
regarding FDA submissions and the potential for marketing
authorizations, 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 and expectations
related to the interest of healthcare providers and payers in PDTs,
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, including BT-001, for commercial distribution and
insurance companies to reimburse their use, market acceptance of
PDTs, including BT-001, 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 our
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, 2022 filed with the
Securities and Exchange Commission (SEC) on August 11, 2022, 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/20221004005347/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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