Submission follows completion of first-in-class
trial demonstrating significant improvements in A1c reduction with
investigational therapy targeting the root causes of type 2
diabetes.
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 it has submitted a
de novo classification request to the U.S. Food and Drug
Administration (FDA) seeking marketing authorization for BT-001,
its potentially first-in-class digital therapeutic designed to use
CBT to treat Type 2 Diabetes (T2D) in patients 18 years and
older.
“Submitting this de novo request is not just a major milestone
for our company but an important moment for patients, providers and
payers. As the first digital therapeutic submitted to the FDA for
the treatment of type 2 diabetes, BT-001 marks a new kind of
treatment paradigm with the potential to address the root causes of
this and other cardiometabolic diseases,” said Mark Berman, MD,
Chief Medical Officer of Better Therapeutics. “By providing people
with convenient, personalized treatment rooted in decades of
behavioral science, we aim to help them take back control and live
healthier lives, instead of relying on increasingly costly
pharmaceutical treatments that place undue burden on patients and
fail to address the behavioral root causes of disease.”
This submission follows positive results from the BT-001 pivotal
trial, the largest randomized control study ever conducted of a
digital therapeutic to evaluate glycemic response in T2D. The trial
met both its primary and secondary endpoints demonstrating
statistically and clinically meaningful reductions in A1c over the
current standard of care, even as control group patients increased
use of blood sugar lowering medications. The results achieved were
sustainable and improved between day 90 and day 180 of the trial,
demonstrating that BT-001 has the potential to deliver meaningful,
durable improvements in blood sugar control for a complex range of
patients with T2D already on standard of care blood sugar lowering
medications.
In addition, exploratory data revealed a host of cardiometabolic
improvements as well as lower medication utilization compared to
the control group, supporting the potential for BT-001 to improve
the overall health of patients with T2D and potentially reduce the
usage of increasingly costly T2D medications associated with the
progression of the disease.
If authorized by the FDA, BT-001 would be the first validated,
prescription solution for delivering CBT to T2D patients at scale,
from their digital devices. In addition to treating T2D with
BT-001, if authorized, Better Therapeutics is exploring the
potential to use CBT for other cardiometabolic conditions,
including nonalcoholic fatty liver disease, nonalcoholic
steatohepatitis, hypertension, and hyperlipidemia.
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 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 nCBT Platform
Better Therapeutics digital therapeutic platform is designed to
delivers 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, expectations related
to the interest of healthcare providers and payers in PDTs and
legislative developments affecting PDTs, the potential to reduce
healthcare and patient costs 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, 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 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, 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/20220922005274/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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