Better Therapeutics Announces Publication of the Rationale, Design and Baseline Characteristics Manuscript for Type 2 Diabetes Pivotal Trial of BT-001, a Novel Prescription Digital Therapy, in Clinical Cardiology
July 11 2022 - 12:13PM
Business Wire
Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital
therapeutics company developing nutritional cognitive behavioral
therapy (nCBT) to address the root causes of cardiometabolic
diseases, today announced the publication of a manuscript detailing
the study design and methodology for its pivotal clinical trial of
BT-001 in adult patients with type 2 diabetes (T2D) in the medical
journal, Clinical Cardiology. The study represents a first-in-class
randomized, controlled clinical trial of a prescription digital
therapeutic (PDT) for the treatment of T2D and is expected to
support the filing of a de novo classification request with the
U.S. Food and Drug Administration (FDA) in the third quarter of
2022. The company announced positive primary endpoint data for this
trial in March of this year and expects to release secondary data
in the third quarter of this year.
The manuscript, titled, “Cognitive behavioral therapy delivered
via digital mobile application for the treatment of type 2
diabetes: Rationale, design, and baseline characteristics of a
randomized, controlled trial,” includes a detailed description of
study design, efficacy and safety endpoints, the nCBT protocols
embedded in BT-001, statistical considerations and baseline
characteristics of the study population. BT-001 is an
investigational digital therapeutic designed to provide nCBT via a
T2D patient’s smartphone to support dietary change, physical
activity and medication adherence for the reduction of A1c.
“This is one of the largest randomized trials of a digital
therapeutic that includes a diverse population of patients that
need more treatment options for their type 2 diabetes," said Dr.
Marc Bonaca, Director of Vascular Research at the University of
Colorado. “The data, to date, support a new approach to treating
type 2 diabetes that does not simply address symptoms but instead
tackles the behavioral causes of the disease. This technology is
promising not just for patients with type 2 diabetes but
potentially for those with a broader range of cardiometabolic
diseases sharing common root causes.”
The open-label, randomized, controlled, parallel group trial
evaluated the efficacy and safety of BT-001 and its ability to
improve glycemic control among patients with T2D. Participants were
randomized to receive standard of care with or without BT-001 and
the primary efficacy endpoint was the difference in mean change
from baseline in A1c after 90 days of treatment between the two
groups. The secondary efficacy endpoint is the change from baseline
to Day 180. Exploratory endpoints include physical measures,
biomarkers, healthcare utilization, and patient-reported outcomes
(PRO). Patients receiving standard of care were on multiple
anti-hyperglycemic meds at baseline and free to adjust meds as
needed. In this way, the design parallels cardiovascular outcome
trials of other medications. The clinical trial enrolled 669 adults
with T2D and supported inclusion and exclusion criteria chosen to
enroll a representative population of adult outpatients with T2D
across population groups often underrepresented in biotech
research, including women, minority groups and patients in low
socioeconomic status neighborhoods.
The manuscript highlights key potential advantages of the
digital therapeutic over in-person nCBT, which include its
scalability, standardization of the intervention, and ease of
access. The latter is particularly important for rural residents
and patients with time, mobility or transportation limitations.
In-clinic CBT is a long-standing and well-studied therapeutic
approach, but broad utilization has been limited by inherent access
and resource constraints. Prescription digital therapeutics that
digitally deliver nCBT have the potential to overcome these
obstacles by making behavioral therapy accessible and affordable to
millions of patients in need.
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, prescription software-based solutions for type 2
diabetes, heart disease and other conditions. The nutritional
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/20220711005733/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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