Better Therapeutics Completes Enrollment of Pivotal Trial for BT-001, a Prescription Digital Therapeutic for Type 2 Diabetes
November 18 2021 - 8:00AM
Business Wire
Primary endpoint data expected in Q1 2022
Better Therapeutics, Inc. (“Better Therapeutics”; NASDAQ: BTTX),
a prescription digital therapeutics company developing cognitive
behavioral therapy to address the root causes of cardiometabolic
diseases, today announced the completion of patient enrollment in
its potentially pivotal study to evaluate the safety and efficacy
of BT-001 for the treatment of type 2 diabetes.
BT-001 is being developed as an FDA-regulated, prescription
digital therapeutic that delivers a novel form of cognitive
behavioral therapy to patients with uncontrolled type 2 diabetes.
The study exceeded its target, enrolling 662 patients from
California, Illinois, Florida, Georgia, New York, and Texas.
“We are deeply thankful to our study participants, investigators
and partners for their dedication to this study. With their help,
we now can demonstrate that use of BT-001 can meaningfully improve
upon the Standard of Care,” said Mark Berman, M.D., chief medical
officer of Better Therapeutics. “With roughly half of all patients
living with type 2 diabetes not reaching treatment goals despite
use of medications, the need for a novel treatment approach is
urgent. We see tremendous potential for the development of
prescription digital therapeutics, such as BT-001, to improve
treatment outcomes without adding to the burden of drug-related
side-effects.”
If positive, study results may support a regulatory submission
for marketing authorization from the U.S. Food & Drug
Administration (FDA). Exploratory endpoint data captured during
this study, including change in insulin resistance, blood lipids,
inflammation, blood pressure and weight, could accelerate the
development of Better Therapeutics’ product candidates to treat
other cardiometabolic conditions.
Better Therapeutics is also conducting a real-world evidence
study with Mass General Brigham, Colorado Prevention Center and
Catalyst Health Network to evaluate the long-term effectiveness and
healthcare utilization changes associated with the use of BT-001.
It is expected that primary care providers will prescribe, and
insurers will reimburse the company’s therapeutics much like they
would a traditional medication.
The Better Therapeutics platform blends clinical, behavioral,
and psychological inputs into a series of therapy lessons and
skill-building modules. These are designed to isolate and shift the
underlying thoughts and beliefs which guide diet and lifestyle
behaviors that cause a wide range of cardiometabolic diseases,
including type 2 diabetes.
Clinical data on the efficacy and safety of Better Therapeutics
developmental product candidates has been published in multiple
peer-review journals including Journal of the Endocrine Society,
JMIR Cardio, JMIR Diabetes and more.
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, software-based solutions for type 2 diabetes, heart
disease and other conditions. The 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
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
approve PDTs and insurance companies to reimburse their use; and
other risks and uncertainties included under the header “Risk
Factors” in the definitive proxy statement/prospectus filed by us
on October 12, 2021.
BTTX-PR
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Heidi Chokeir heidi.chokeir@canalecomm.com +1 619 203 5391
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