Data demonstrates BT-001 was durable with A1c
reductions continuing to improve after 180 days of treatment
On track to submit a de novo classification
request with FDA for BT-001 in third quarter of 2022
Company to host conference call and webcast
today at 8:30 a.m. ET
Better Therapeutics, Inc. (“Better Therapeutics”, NASDAQ: BTTX),
a prescription digital therapeutics company developing nutritional
cognitive behavioral therapy (nCBT) to address the root causes of
cardiometabolic diseases, today announced the completion of the
pivotal clinical trial for BT-001, an investigational
first-in-class prescription digital therapeutic that is designed to
use nCBT to treat type 2 diabetes (T2D).
With the positive data reported by this pivotal clinical trial,
Better Therapeutics intends to submit a de novo classification
request to the U.S. Food and Drug Administration (FDA) in the third
quarter of 2022, seeking marketing authorization for BT-001 for the
treatment of patients with T2D. If granted, BT-001 would become the
first prescription digital therapeutic for the treatment of
T2D.
“Today’s announcement is a moment to celebrate – not just for
the team at Better Therapeutics – but for the patients and health
care providers who know all too well that the way we treat T2D
today simply isn’t good enough given the magnitude of this epidemic
disease,” said Frank Karbe, president and CEO of Better
Therapeutics. “We believe the data from this trial is remarkable,
given we enrolled a diverse patient population with advanced
disease already on rigorous blood sugar lowering regimens and who
could self-select their dose of BT-001, unlike in traditional new
drug pivotal trials. The positive data from this trial serves as an
important stepping stone towards our goal of bringing BT-001 to
patients and physicians in need of new therapies, and entering the
next phase of our growth as a commercial-stage company.”
This data follows the announcement in March that the trial had
met its primary endpoint at day 90 with a p-value of < 0.0001.
The secondary endpoint data assessed at day 180 continued this
trend, showing statistically significant decreases in A1c levels
when compared to a control group receiving standard of care
(p-value = 0.01). The results achieved were sustainable and
improved between day 90 and day 180 of the trial, demonstrating
that BT-001 has the potential to deliver meaningful, durable
improvements in blood sugar control for a complex range of patients
with T2D already on standard of care blood sugar lowering
medications. In addition, exploratory data revealed a host of
cardiometabolic improvements as well as lower medication
utilization compared to the control group, supporting the potential
for BT-001 to improve the overall health of patients with T2D and
potentially reduce the usage of increasingly costly T2D medications
associated with the progression of the disease.
“As a physician focused on cardiometabolic conditions, it’s a
rare and important moment to see an entirely new treatment paradigm
emerge for patients with T2D, but that’s what we potentially have
with this digital therapeutic approach,” said Mark Berman, MD,
Chief Medical Officer of Better Therapeutics. “For too long, the
treatment options available to people with T2D have largely been
prescription medications that help reduce symptoms but do little to
address the underlying causes of disease. This pivotal trial of
digitally delivered nCBT in a complex patient population with
advanced and difficult to treat disease generated results that were
durable and a notable improvement over the current standard of
care. The results also suggest that BT-001 has the potential to
reduce the need for medications and lower healthcare
utilization.”
Among the encouraging results shown were:
- Sustained and improved A1c levels in patients using BT-001,
with average absolute A1c reduction improving from 0.3% at day 90
to 0.4% at day 180, supporting that the treatment effects of BT-001
were durable.
- The difference in A1c levels after 180 days of treatment
between BT-001 treated patients and Standard of Care (SOC) control
group patients receiving standard of care remained statistically
significant (p=0.01) even as more SOC patients increased blood
sugar lowering medications.
- Half of patients using BT-001 experienced clinically meaningful
A1c reductions with a mean reduction of 1.3% in this subgroup at
180 days (SD 0.8%).
- Results indicated that patients who did not use BT-001 were
more likely to be placed on additional medications to improve A1c
control. After the day 180 A1c draw, 1.7 times more SOC control
patients increased their medications compared to BT-001
patients.
- BT-001 demonstrated reassuring safety, with significantly fewer
adverse (p<0.001) and serious adverse events (p=0.01) as
compared to the SOC control group.
- A clear dose-response between greater engagement in nCBT and
greater reductions in A1c was found, supporting nCBT as a mechanism
of action.
The open label, randomized, controlled, parallel group trial
enrolled a nationally representative group of 668 adults with T2D
and mean baseline A1c of 8.1%. Participants in the trial had long
standing T2D (mean 11 years), multiple comorbidities, and were
already on multiple diabetes medications, representing a difficult
to treat patient population. 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 trial
was designed with a high bar to pass and to avoid artificial
designs that could produce large outcomes that do not apply to all
patients. This includes not constraining patients to a specific
medication profile and not incentivizing patients to use the BT-001
therapy.
“The results of this trial are not just encouraging for patients
with T2D mellitus but mark the start of a potential sea change in
how we approach treatment of cardiometabolic diseases and their
root causes,” said Marc Bonaca, MD, MPH, professor of medicine and
director of vascular research, University of Colorado. “If we can
deliver a scalable, sustainable and clinically validated way to
make important and durable improvements in cardiometabolic disease,
we can empower patients to take back control of their health from
these costly, common chronic diseases.”
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, July 28, 2022, at 8:30 a.m. ET to review the results from
the pivotal clinical trial of BT-001 after 180 days of treatment
for T2D. The live conference call may be accessed by dialing (800)
715-9871 (domestic) or (646) 307-1963 (international) and referring
to conference ID: 4326594. All participants are encouraged to
dial-in 10 minutes prior to the start time. The live webcast may be
accessed by visiting the event page here. A replay of the webcast
may be accessed from the Presentations & Events page in the
Investors section of the Better Therapeutics corporate website:
www.bettertx.com.
About BT-001
BT-001 is Better Therapeutics’ investigational prescription
digital therapy for the treatment of T2D. The investigational
therapy is delivered via software that provides a tailored
experience to patients designed to help them address the underlying
causes of T2D by making meaningful, sustainable behavioral changes.
The BT-001 investigational therapy is rooted in the well-studied,
gold standard of behavioral modification therapies, cognitive
behavioral therapy (CBT). While CBT has been used for T2D and other
cardiometabolic conditions before, until now the approach has not
been scalable due to the need to deliver the therapy via a
therapist. If authorized by FDA, BT-001 would be the first
validated, prescription solution for delivering this therapeutic
approach to T2D patients at scale, from their digital devices.
About the Better Therapeutics nCBT Platform
Better Therapeutics digital therapeutic platform is designed to
delivers a novel form of CBT - nutritional CBT (nCBT) - to help
people with cardiometabolic diseases potentially improve key
measures related to T2D, nonalcoholic fatty liver disease,
nonalcoholic steatohepatitis, hypertension, hyperlipidemia and
other cardiometabolic conditions. By adapting the principles and
mechanisms of cognitive behavioral therapy, the digital therapeutic
platform is designed to address and modify the cognitive patterns
that affect eating habits and other behavioral factors associated
with cardiometabolic diseases.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT)
company developing a novel form of cognitive behavioral therapy
(CBT) 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 CBT 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, if authorized for marketing, 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 clinical trial of BT-001 in patients with type 2
diabetes, Better Therapeutics’ plans regarding FDA submissions,
plans and expectations regarding the commercialization of BT-001,
if authorized, 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, and expectations
related to the interest of healthcare providers and payers in PDTs,
including BT-001, 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, including BT-001, for commercial distribution and
insurance companies to reimburse their use, market acceptance of
PDTs, including BT-001, 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
Better Therapeutics’ annual report on Form 10-K for the year ended
December 31, 2021 filed with the Securities and Exchange Commission
(“SEC”) on March 28, 2022, and those that are included in any of
the Company's future filings with the SEC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220728005143/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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