Open-label, randomized, controlled real world
study will evaluate use of BT-001, a prescription digital
therapeutic (“PDT”) designed to treat type 2 diabetes by changing
the behaviors that are root causes
Mass General Brigham joins the Colorado
Prevention Center and Catalyst Health Network to evaluate the
long-term effectiveness and impact on healthcare costs associated
with BT-001 in patients with uncontrolled type 2 diabetes
Better Therapeutics, Inc. (“Better Therapeutics”), a
prescription digital therapeutics company developing cognitive
behavioral therapy to address the root causes of cardiometabolic
diseases, in collaboration with Mass General Brigham, today
announced the commencement of a real-world evidence study to
evaluate the long-term effectiveness and healthcare utilization
changes associated with the use of BT-001, a PDT delivering
nutritional cognitive behavioral therapy for the treatment of type
2 diabetes.
Mass General Brigham will conduct an open-label, randomized,
controlled study of approximately 750 patients with type 2
diabetes, extending Better Therapeutics’ ongoing effort to
demonstrate real world effectiveness of the use of BT-001.
Participants will include individuals with A1c levels between 7%
and 11% across multiple insurance plans. The primary objective of
the study is to evaluate effectiveness, durability of effect, and
changes in healthcare utilization and quality of life among
participants using BT-001. Changes in blood pressure, blood lipids,
weight, cardiometabolic medications, cardiometabolic medication
costs and medical costs will also be evaluated. The study will be
conducted for at least 18 months and may be extended.
“Despite the availability of existing pharmacologic therapies
with proof of effectiveness and safety, control of blood glucose,
blood pressure, and other target biomarkers remains a problem for
many patients with type 2 diabetes leading to morbidity and
mortality,” said Christopher Cannon, MD, Cardiologist in the
Division of Cardiovascular Medicine at Brigham and Women’s Hospital
and Director of Education at the Digital Care Transformation team
of Mass General Brigham. “Cognitive behavioral therapy in the form
of a digital therapeutic like BT-001 may offer the needed support
for patients to make meaningful and lasting behavior changes to
positively impact the course of their disease.”
“Mass General Brigham continues to enhance our ability to
improve the quality of care of our patients with cardiovascular
disease and diabetes through digital care transformation,” said
Benjamin Scirica, MD, MPH, Director of Innovation, Division of
Cardiovascular Medicine at Brigham and Women’s Hospital and Program
Lead of the Digital Care Transformation team of Mass General
Brigham. “We see great potential for a prescription digital
therapeutic and the data it can provide our team to both improve
patient outcomes and the quality of care in our remote treatment
setting. We are excited to participate in the evaluation of BT-001
in a real world setting of participants enrolled in our remote
health care program.” Mass General Brigham joins the Colorado
Prevention Center and Catalyst Health Network in the study of
BT-001, an investigational, prescription digital therapeutic that
delivers a novel form of cognitive behavioral therapy to patients
with uncontrolled type 2 diabetes.
“With a growing number of patients with type 2 diabetes now
being managed in non-traditional remote care settings, Mass General
Brigham’s Digital Care Transformation program presents an important
opportunity to evaluate the role and use of our PDT in this
evolving and innovative system of care,” said Mark Berman, MD,
chief medical officer at Better Therapeutics. “We are excited to
collaborate with Drs. Scirica and Cannon and the team at Mass
General Brigham.”
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 potentially pivotal study as a prescribed treatment used under
physician supervision for people with uncontrolled type 2 diabetes.
If positive, data from the pivotal study will be used by Better to
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 causes 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 from studies evaluating the effectiveness of
Better Therapeutics developmental product candidates have been
published in multiple peer-reviewed journals including Journal of
the Endocrine Society, JMIR Cardio, JMIR Diabetes and more.
About Mass General Brigham
Mass General Brigham is an integrated academic healthcare
system, uniting great minds in medicine to make life-changing
impact for patients in our communities and people around the world.
Mass General Brigham connects a full continuum of care across a
system of academic medical centers, community and specialty
hospitals, a health insurance plan, physician networks, community
health centers, home care, and long-term care services. Mass
General Brigham is a non-profit organization that is committed to
patient care, research, teaching, and service to the community. In
addition, Mass General Brigham is one of the nation’s leading
biomedical research organizations and a principal teaching
affiliate of Harvard Medical School. For more information, please
visit massgeneralbrigham.org.
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
Additional Information
Mountain Crest Acquisition Corp II (“Mountain Crest II”) has
filed, and the SEC has declared effective, a registration statement
on Form S-4 (the “Registration Statement”) containing a definitive
proxy statement/prospectus of Mountain Crest II relating to the
proposed Business Combination. Mountain Crest II has mailed the
definitive proxy statement/prospectus and other relevant documents
to its shareholders. Investors, Mountain Crest II’ shareholders and
other interested persons are advised to read the definitive proxy
statement/prospectus in connection with Mountain Crest II’
solicitation of proxies for the Special Meeting to be held to
approve the Business Combination as these materials will contain
important information about the Company and Mountain Crest II and
the proposed Business Combination. The definitive proxy
statement/prospectus has been mailed to the shareholders of
Mountain Crest II as of the record date of September 8, 2021;
shareholders that hold their shares in registered form are entitled
to vote their shares held on the date of the meeting. Shareholders
are also able to obtain copies of the definitive proxy
statement/prospectus and other documents filed with the SEC,
without charge, at the SEC’s website at http://www.sec.gov, or by
directing a request to: Mountain Crest II Acquisition Corp., 311
West 43rd Street, 12th Floor, New York, NY 10036.
Participants in the Solicitation
Mountain Crest II and its 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
II’s executive officers and directors in the solicitation by
reading Mountain Crest II’s Form S-4 and other relevant materials
filed with the SEC in connection with the proposed business
combination. 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, are set forth in the Form S-4
relating to the proposed business combination. 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 are 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
This press release contains “forward-looking statements” within
the meaning of the United States Private Securities Litigation
Reform Act of 1995. These forward-looking statements include, but
are not limited to, statements regarding the delivery of cognitive
behavioral therapy by Better Therapeutics to address the root
causes of type 2 diabetes and other cardiometabolic diseases;
development of a proprietary platform and software-based solutions
for treatment of type 2 diabetes, heart disease and other
conditions; achievement of changes in neural pathways of the brain
and lasting changes in behavior through cognitive behavioral
therapy delivered by Better Therapeutics’ PDT; the capability of
Better Therapeutics to address the underlying causes of certain
diseases and its related potential to improve patient health while
lowering healthcare costs; the potential for Better Therapeutics’
clinically validated mobile applications to be prescribed by
physicians and reimbursed like traditional medicines; potential and
significance of the results of the pivotal study of BT-001 or any
clinical or other trial; the potential success of BT-001 as a
prescribed treatment used under physician supervision for people
with uncontrolled type 2 diabetes; the possibility for the results
of the pivotal study to support a regulatory submission for
marketing authorization from the FDA; the potential timing of, and
Better Therapeutics’ expected progress towards developing and
obtaining FDA approval for its products, related research and
validation studies. 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. Any
forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk that the
FDA may not be satisfied with the design of any of Better
Therapeutics’ studies and trials, and even satisfied, payers may
not reimburse BT-001, if approved,, 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 the
risk that the current COVID-19 pandemic will impact Better
Therapeutics’ platform validation, product testing, the timing of
the Better Therapeutics’ submission of the BT-001 for marketing
approval from the FDA and other operations. For a discussion of
other risks and uncertainties, and other important factors, any of
which could cause Better Therapeutic’s actual results to differ
from those contained in the forward-looking statements, see the
section entitled “Risk Factors” in Mountain Crest II’s filings on
file with the Securities and Exchange Commission, available at the
Securities and Exchange Commission’s website at www.sec.gov, and as
well as discussions of potential risks, uncertainties and other
important factors in Mountain Crest II and/or Better Therapeutics’
subsequent/future filings, if any, with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
BTTX-PR
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version on businesswire.com: https://www.businesswire.com/news/home/20211102005289/en/
Mass General Brigham Contact: Bridget Perry, 617-282-0608
Bperry7@partners.org Investor relations: Debra Sloan,
857-282-0592
Better Therapeutics Media Contact Heidi Chokeir, PhD
heidi.chokeir@canalecomm.com +1 619 203 5391
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