Open-label, real-world study will evaluate
BT-001’s cognitive behavioral therapy approach to change behaviors
at the root cause of type 2 diabetes
Study to evaluate the durability of treatment
effect and healthcare utilization changes associated with BT-001 in
Catalyst’s community-based, clinically integrated, primary care
setting
Better Therapeutics, Inc. (“Better Therapeutics”), a
prescription digital therapeutics company developing cognitive
behavioral therapy to address the root causes of cardiometabolic
diseases, in partnership with Catalyst Health Network (“Catalyst”),
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 for the treatment of type
2 diabetes. Catalyst joins the Colorado Prevention Center 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.
The open-label study of approximately 250 patients with type 2
diabetes will be recruited from Catalyst’s primary care ecosystem,
extending Better’s ongoing effort to evaluate real world
effectiveness of the use of BT-001. Eligible participants will
include individuals with A1c levels between 7% and 11%. The primary
objective of the study is to evaluate effectiveness, durability of
effect, changes in healthcare utilization and quality of life from
their baseline. 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 one year and may be extended.
“Almost 90% of all type 2 diabetes patients in the U.S. are
treated within a primary care setting. Physicians and their
treatment teams need prescribable and scalable therapeutics that
address the behavioral root causes of type 2 diabetes,” said Mark
Berman, MD, chief medical officer of Better Therapeutics. “We are
looking forward to working with the team at Catalyst Health Network
to lead the evaluation of BT-001 in their clinically integrated,
community based primary care setting. Catalyst’s care management
team and pharmacists are uniquely suited to evaluate BT-001 in a
real-world setting.”
“Catalyst is excited to partner with Better Therapeutics on this
study of BT-001. Improving outcomes for patients with type 2
diabetes is an area of crucial focus for us, and we see great
potential for a prescribable, behavior-based, digital therapeutic
used in the primary care setting,” said Dr. Jeff Bullard, chief
medical officer and executive director for Catalyst Health
Network.
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 Catalyst Health Network
Catalyst Health Network enables primary care to be the
difference-maker in patients’ lives that it was always meant to be.
As a URAC-accredited clinically integrated network of more than
1,000 primary care providers, Catalyst provides integrated care
management and support for more than 1.5 million patients through
each stage of care to improve health and reduce overall costs in
sustainable, scalable ways. For more information visit:
catalysthealthnetwork.com.
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
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 has
filed 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 includes 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 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210824005215/en/
Catalyst Health Network Contact Danny DeAtley Senior Vice
President, Marketing Catalyst Health Network & StratiFi Health
Mobile: 214-548-3816 ddeatley@stratifihealth.com
Better Therapeutics Media Contact Heidi Chokeir, PhD
heidi.chokeir@canalecomm.com +1 619 203 5391
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