First prescription digital behavioral
therapeutic device delivering novel form of cognitive behavioral
therapy via smartphone
In a randomized controlled trial AspyreRx
demonstrated clinically meaningful and statistically significant
durable reductions in A1c
Company to host conference call and webcast on
July 11 at 8:30 a.m. ET
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing software to treat cardiometabolic diseases, today
announced that the Food and Drug Administration (FDA) authorized
AspyreRx™ (formerly BT-001), a prescription-only digital
therapeutic (PDT) treatment indicated to provide cognitive
behavioral therapy to patients 18 years or older with type 2
diabetes (T2D). AspyreRx was reviewed through the FDA’s De Novo
pathway and its authorization creates a new class of diabetes
digital behavioral therapeutic devices. AspyreRx is expected to
launch commercially in Q4 2023.
"AspyreRx is a game-changer as we now have an evidence-based
intervention to help clinicians and people living with type 2
diabetes address the underlying factors that contribute to disease
progression and achieve treatment outcomes beyond glucose
management alone,” said David Kerr MBChB, DM, FRCP, FRCPE, Director
of Digital Health at the Diabetes Technology Society. "The
cornerstone of modern diabetes care is helping to improve
self-efficacy and AspyreRx now provides a prescription tool for
physicians that seamlessly integrates with existing disease
management programs to help patients make and sustain meaningful
changes to improve their overall health.”
“This regulatory milestone signals a promising future where
technology, psychology, and medicine converge to address for the
first time the behavioral causes of disease for the 37 million
patients living with T2D in the U.S.,” said Frank Karbe, Chief
Executive Officer at Better Therapeutics. “This De Novo
authorization also provides a foundation for potential future
growth opportunities. Given cardiometabolic diseases share common
underlying factors that contribute to their development and
progression, we intend to expand our PDT platform to multiple
related conditions in the future.”
AspyreRx was granted marketing authorization based on efficacy
and safety data from a randomized controlled trial involving 668
participants, demonstrating clinically meaningful results, which
were published in Diabetes Care.
Summary of Clinical Trial Results
- The trial met its primary (p<0.0001) and secondary (p=0.01)
endpoints showing statistically significant decreases in HbA1c
levels when compared to a control group receiving standard of care
and a control app. The results were sustained and improved between
day 90 and day 180 of the trial, demonstrating that BT-001 has the
potential to deliver meaningful, durable reductions in blood sugar
for a complex range of patients with T2D.
- 1 in 2 people achieved a mean A1c reduction of 1.3% after 180
days of use.
- On average, subjects who used BT-001 also experienced a host of
cardiometabolic improvements including improved fasting blood
glucose, reduced systolic blood pressure, reduced weight, improved
mood, improved quality of life scores, lower medication utilization
and fewer diabetes related risks compared to subjects who did not
use BT-001.
- A clear dose-response between greater engagement in CBT and
greater reductions in HbA1c was found, supporting CBT as a
mechanism of action to generate positive clinical outcomes.
- Patient engagement and adherence was excellent with 94% of the
participants using the intervention at day 90 and 81% still engaged
at day 180.
The majority of patients with T2D progress in their disease,
despite advances in pharmacotherapy. Treatment guidelines emphasize
lifestyle behavior change as the cornerstone in the prevention and
treatment of disease; however, given the constraints of delivering
in-person therapy there has been limited advancement in helping
patients make and sustain behavior change in a way that is
standardized, convenient and scalable. AspyreRx is designed to
address these barriers, leveraging technology to deliver an
evidence-based therapeutic intervention to patients. The
involvement of healthcare providers adds an important layer of
expertise and oversight, ensuring seamless coordination between
AspyreRx and other aspects of treatment.
“Our team has dedicated eight years to developing this treatment
and we are grateful for the thousands of patients who have used our
platform and for the many clinicians who have guided us to this
point,” said Mark Berman, MD, Chief Medical Officer at Better
Therapeutics. “We are immensely proud of this milestone and believe
AspyreRx holds the promise to enhance access to care for the
diversity of the patient population, empowering individuals to live
healthier lives.”
Better Therapeutics Conference Call and Webcast
Better Therapeutics will hold a conference call on July 11 at
8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA
authorization of AspyreRx. Investors and the general public may
access a live webcast of the call by visiting
https://edge.media-server.com/mmc/p/adggoags
About Type 2 Diabetes
Type 2 diabetes (T2D) is a widespread chronic disease in the
U.S. According to the Centers for Disease Control and Prevention
(CDC), around 35 million people in the U.S. have T2D. About half of
the T2D patients have uncontrolled blood sugars despite being on
multiple medications. The prevalence of T2D has been steadily
increasing over the years, primarily due to factors such as
sedentary lifestyles, poor dietary habits, and an aging population.
T2D disproportionately affects certain populations, particularly
racial and ethnic minority groups, and those from lower
socioeconomic backgrounds. Factors like limited access to
healthcare, health disparities, cultural differences, and social
determinants of health contribute to these disparities. Addressing
health inequities, slowing down disease progression and preventing
costly complications, without overuse of high-cost therapies, is a
major unmet need in T2D.
About AspyreRx
AspyreRx (formerly BT-001) is Better Therapeutics’ clinically
validated prescription digital therapy for the treatment of T2D.
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 anytime/anywhere. 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. AspyreRx is backed by robust data demonstrating clinically
meaningful and sustained reduction in HbA1c when used up to 180
days.
Indications for Use
BT-001 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. BT-001 provides cognitive
behavioral therapy as a treatment that should be used adjunctively
with standard of care.
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 and expectations regarding FDA
submissions, 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 BT-001 and CBT
and their potential treatment applications, the potential of
AspyreRx to address barriers and enhance access to care, Better
Therapeutics’ plans regarding the research and advancement of its
product candidates for additional treatments, expectations related
to pricing research and results and the interest of healthcare
providers and payers in PDTs, Better Therapeutics’ plans regarding
publications, and statements related to its long-term plans and
expectations, 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 March 31, 2023
filed with the Securities and Exchange Commission (SEC) on May 11,
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/20230710624673/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Inquiries: Emma Williams
emma.williams@bettertx.com
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