Open-label, non-randomized, controlled study
will span one year and evaluate BT-001’s cognitive behavioral
therapy approach to change behaviors at root cause of type 2
diabetes
Study to evaluate the durability of treatment
effect and total cost of care impact of BT-001 in a diverse,
real-world clinical setting with topline primary endpoint data
expected in 2H 2022
Better Therapeutics, Inc. (“Better Therapeutics”), a
prescription digital therapeutics company delivering cognitive
behavioral therapy to address the root causes of cardiometabolic
diseases, today announced the commencement of a real-world evidence
study with Steward Health Care to evaluate the long-term
effectiveness and cost of care impact associated with the use of
BT-001 for the treatment of type 2 diabetes. BT-001 is an
investigational, prescription digital therapeutic that delivers a
novel form of cognitive behavioral therapy to patients with
uncontrolled type 2 diabetes.
The open-label, non-randomized, controlled study will evaluate
approximately 1,000 patients with type 2 diabetes in Steward Health
Care engaged with BT-001 for one year. Participants will include
individuals with A1c levels between 7% and 11% across Medicare,
Medicaid, and commercial health insurance plans. The primary
objective of the study is to evaluate the change in A1c and total
healthcare costs after one year of treatment compared to the
control group. One year changes in blood pressure, blood lipids,
weight, cardiometabolic medications, cardiometabolic medication
costs and medical costs will also be evaluated.
The company anticipates reporting topline primary endpoint data
in the second half of 2022.
“With the astronomical and growing cost of care for patients
with type 2 diabetes and other cardiometabolic conditions,
patients, providers and payers all deserve therapeutics that
address the root causes of disease, yet we continue to spend
hundreds of billions of dollars on medicines that only address
symptoms,” said Kevin Appelbaum, co-founder and chief executive
officer of Better Therapeutics. “We believe our prescription
digital therapeutic has the power to positively disrupt the current
standard of care and help patients with behavior-driven conditions,
translating to improved patient outcomes and significant healthcare
savings. We look forward to the results of this study, which will
generate important evidence that we believe could provide support
for payer reimbursement.”
Better Therapeutics and Steward Health Care have agreed to
non-disclosed business terms aligned toward achieving timely
delivery of evidence for 1,000 patients.
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. BT-001 is concurrently being evaluated
in a pivotal study as a prescribed treatment used under physician
supervision for people with uncontrolled type 2 diabetes. If
positive, the pivotal study will support a regulatory submission
for marketing authorization from the U.S. Food & Drug
Association (FDA).
BT-001 is Better Therapeutics’ lead product candidate among
their pipeline of FDA-regulated, prescription digital therapeutics
designed to treat the underlying cause of a range of
cardiometabolic conditions. It is anticipated that upon marketing
authorization, primary care providers will prescribe, and insurers
will reimburse the company’s therapeutics, much like they would a
traditional medication.
Clinical data demonstrating 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 delivering 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 enables 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
Additional Information
On April 6, 2021 Better Therapeutics entered into a definitive
merger agreement with Mountain Crest Acquisition Corp. II (Nasdaq:
MCAD) (“Mountain Crest II”), a special purpose acquisition company
for a proposed business combination.
In connection with the proposed business combination between
Mountain Crest II and Better Therapeutics, Mountain Crest II will
file a registration statement on Form S-4 containing a proxy
statement/prospectus (the “Form S-4”) with the Securities and
Exchange Commission (the “SEC”). The Form S-4 will include a proxy
statement to be distributed to holders of Mountain Crest II’s
common stock in connection with Mountain Crest II’s solicitation of
proxies for the vote by Mountain Crest II’s shareholders with
respect to the proposed transaction and other matters as described
in the Form S-4, as well as the prospectus relating to the offer of
securities to be issued to Better Therapeutics’ stockholders in
connection with the proposed business combination. After the Form
S-4 has been filed and declared effective, Mountain Crest II will
mail a definitive proxy statement, when available, to its
stockholders. Investors and security holders and other interested
parties are urged to read the Form S-4, any amendments thereto and
any other documents filed with the SEC carefully and in their
entirety when they become available because they will contain
important information about Mountain Crest II, Better Therapeutics
and the proposed business combination. Additionally, Mountain Crest
II will file other relevant materials with the SEC in connection
with the business combination. Copies of these documents may be
obtained free of charge at the SEC's web site at www.sec.gov.
Securityholders of Mountain Crest II are urged to read the Form S-4
and the other relevant materials when they become available before
making any voting decision with respect to the proposed business
combination because they will contain important information. The
information contained on, or that may be accessed through, the
website referenced in this press release is not incorporated by
reference into, and is not a part of, this press release.
Participants in the Solicitation
Mountain Crest and Better Therapeutics and their respective
directors and executive officers may be deemed participants in the
solicitation of proxies with respect to the proposed business
combination under the rules of the SEC. Securityholders may obtain
more detailed information regarding the names, affiliations, and
interests of certain of Mountain Crest’s executive officers and
directors in the solicitation by reading Mountain Crest’s Form S-4
and other relevant materials filed with the SEC in connection with
the proposed business combination when they become available.
Information about Mountain Crest II’s directors and executive
officers and their ownership of Mountain Crest II common stock is
set forth in Mountain Crest II’s annual report on Form 10-K for the
year ended December 31, 2020, dated March 30, 2021 , as modified or
supplemented by any Form 3 or Form 4 filed with the SEC since the
date of that filing. Other information regarding the interests of
Mountain Crest II’s participants in the proxy solicitation, which
in some cases, may be different than those of their stockholders
generally, will be set forth in the Form S-4 relating to the
proposed business combination when it becomes available. These
documents can be obtained free of charge at the SEC's web site at
www.sec.gov.
Better Therapeutics and its directors and executive officers may
also be deemed to be participants in the solicitation of proxies
from the stockholders of Mountain Crest II in connection with the
proposed business combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed business combination will be included in
the Form S-4 for the proposed business combination.
Non-Solicitation
This press release shall not constitute a solicitation of a
proxy, consent, or authorization with respect to any securities or
in respect of the proposed business combination. This press release
shall also not constitute an offer to sell or the solicitation of
an offer to buy any securities, nor shall there be any sale of
securities in any states or jurisdictions in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended, or an exemption therefrom.
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, including statements about patient enrollment
and potential clinical outcomes. In addition, any statements that
refer to projections (including EBITDA, adjusted EBITDA, EBITDA
margin and revenue projections), forecasts or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210414005232/en/
Better Therapeutics Media Contact Heidi Chokeir
heidi.chokeir@canalecomm.com +1 619 203 5391
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