1,000 participants enrolled across two studies,
and six sites
Studies will evaluate clinical effectiveness
beyond 6 months, impact on medication use and healthcare
utilization
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing prescription digital therapeutics (PDTs) to treat
cardiometabolic diseases, today announced it has completed the
enrollment of 1,000 participants across two studies as part of its
ongoing clinical program to evaluate the long-term effectiveness of
AspyreRxTM (formerly BT-001). AspyreRx received FDA authorization
in July 2023 as the first PDT to deliver Cognitive Behavioral
Therapy (CBT) to treat adults with type 2 diabetes (T2D).
Better Therapeutics' ongoing clinical studies are designed to
assess the long-term effectiveness of AspyreRx in diverse
populations, as measured by change in HbA1c, and safety, as
measured by severity and frequency of adverse events. The impact on
medication use and healthcare utilization one year after beginning
treatment with AspyreRx will also be evaluated, along with an
advanced understanding of patient engagement patterns in a
real-world setting. In addition, these studies intend to inform the
durability of this digital therapeutic intervention.
Participants have been enrolled across Colorado Prevention
Center (CPC), affiliated with the University of Colorado Anschutz
Medical Campus, the Durham Veterans Association (VA) Health Care
System, Ascension DePaul, and Mass General Brigham (MGB). All
enrolled participants have been randomized and on-boarded onto
AspyreRx or a control app.
“Ongoing studies like these are a critical compass needed in the
implementation of healthcare innovation, and today we celebrate a
significant milestone in the continued evaluation of digital
therapies like AspyreRx,” said Marc Bonaca, MD, Executive Director
of CPC Clinical Research. “These studies now extend experience with
AspyreRx to participants of diverse geographies, health systems,
and racial and ethnic groups for longer durations and in real-world
settings and are poised to provide patients, clinicians, and others
with a broad understanding of how a prescribable behavioral
treatment can be best implemented.”
Depending on adequate power, Better Therapeutics plans to share
initial 6-month data by the end of 2023. This initial readout is
expected to be followed by additional data releases in 2024.
“Behavioral changes to improve diet and lifestyle are critical
for patients with diabetes, but few providers are trained to help
patients make meaningful changes,” said Benjamin M. Scirica, MD,
MPH. Director, Innovation, Cardiovascular Division, Brigham and
Women’s Hospital and Associate Professor, Harvard Medical School.
“We are excited to be testing AspyreRx in a diverse population of
patients with diabetes in order to understand how prescribable
behavioral therapies can affect the management of metabolic
diseases.”
"As we announce completion of enrollment in these additional
studies I am thrilled to share that we are on track for AspyreRx to
be commercially available in Q4 of this year," said Frank Karbe,
Chief Executive Officer, Better Therapeutics. “Our launch will
initially focus on geographies where innovative regional payers
overlap with providers who are seeing the highest number of type 2
diabetes patients. Our latest healthcare provider research and
feedback from our ongoing discussions with payers gives us
confidence that we will be able to generate meaningful commercial
traction, including payer coverage, within these initial launch
geographies."
About AspyreRx
AspyreRx (fka BT-001) was granted marketing authorization by the
U.S. Food and Drug Administration (FDA) in July 2023 as the first
prescription-only digital behavioral therapeutic device delivering
a novel form of cognitive behavioral therapy (CBT) via smartphone
to treat adults with type 2 diabetes (T2D). AspyreRx is backed by
robust data demonstrating clinically meaningful and sustained
reduction in HbA1c as well as improvements in other markers of
cardiometabolic health when used up to 180 days. 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.
Indications for Use
AspyreRx 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. AspyreRx 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 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
timing of results from, and Better Therapeutics’ plans for, its
ongoing studies evaluating long-term effectiveness of AspyreRx in
patients with T2D, Better Therapeutics’ plans regarding the
research and advancement of its product candidates for additional
treatments and Better Therapeutics’ plans and expectations
regarding the results of discussions with healthcare providers and
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, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230928483146/en/
Investor Relations: Mark Heinen IR@bettertx.com Media
Enquiries: Emma Williams info@bettertx.com
Better Therapeutics (NASDAQ:BTTX)
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