Better Therapeutics Announces Positive Primary Endpoint Data From Pivotal Clinical Trial of BT-001, a Prescription Digital Therapeutic (PDT) for Patients With Uncontrolled Type 2 Diabetes
March 15 2022 - 7:00AM
Business Wire
Data Demonstrates Clinically Meaningful and
Statistically Significant Results, Improving Glycemic Control by
Reducing A1c 0.4% Versus the Control Group Receiving Standard of
Care
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 primary endpoint data
from its pivotal trial of BT-001, a first-in-class investigational
PDT platform that is designed to use digitally delivered nCBT to
treat type 2 diabetes.
The open label, randomized, controlled, parallel group trial
enrolled 669 adults with type 2 diabetes and mean baseline A1c of
8.1%. 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. Following is an overview of key
takeaways from the 90-day data:
- The clinical trial included a diverse, nationally
representative patient population including participants from
minority groups often underrepresented in diabetes studies. 40.2%
of participants were non-white; 15.7% were Hispanic or Latin
American.
- Participants had long-standing type 2 diabetes, high
cardiovascular risk, multiple comorbidities with use of multiple
medications.
- The primary efficacy endpoint (n=602) showed highly
statistically significant improvement in A1c between the
intervention and control groups (-0.4%, p <0.001).
- Clinically meaningful changes (A1c reductions of 0.4% or more)
occurred in 42.7% of the group receiving standard of care and
BT-001 vs. 25.4% in the group receiving standard of care alone
(difference of 17.3%, p <0.001); we believe this demonstrates
use of BT-001 significantly improved A1c compared to standard of
care alone.
- There was a clear dose-response between greater engagement in
nCBT and greater reductions in A1c, supporting nCBT as a mechanism
of action.
- Measures of patient engagement, adherence, persistence, and
satisfaction were all positive.
- No meaningful differences in safety events were observed
between groups.
The six-month trial is ongoing and is expected to be completed
in Q2 2022. Given the compelling benefit-to-risk profile of BT-001
and highly statistically significant 0.4% reduction in A1c, Better
Therapeutics intends to file a De Novo classification request with
the FDA upon completion of the study.
“The data we’re unveiling today is a critical step in our
journey to reimagine how cardiometabolic diseases are treated. By
demonstrating that BT-001 can improve glycemic control at 90 days
by addressing the behaviors that are root causes of type 2
diabetes, even in a very sick, poorly controlled population with
long-standing diabetes, we not only open a new avenue of potential
treatment, but a new horizon for non-pharmaceutical approaches to
care,” said Dr. Mark Berman, chief medical officer of Better
Therapeutics. “If these positive trends continue, we see the
potential to advance PDTs to improve health and reduce reliance on
medications.”
“The existing treatment paradigm for type 2 diabetes relies
almost exclusively on the use of traditional medications to address
the symptoms of the disease, while doing very little about the
behaviors that are the underlying causes. We created nutritional
CBT delivered as a prescription digital therapeutic to fill a known
gap in clinical care,” said Kevin Appelbaum, co-founder and CEO of
Better Therapeutics. “This primary endpoint data for BT-001
suggests that we are not only on the right track for creating a
safe and effective treatment for type 2 diabetes, but that
nutritional CBT may offer potential across a broad range of
cardiometabolic conditions.”
Better Therapeutics intends to advance its product pipeline
candidates BT-002 and BT-003, for the treatment of hypertension and
hyperlipidemia, respectively, to pivotal trials after the
completion of its pivotal trial in type 2 diabetes. The company
will soon begin clinical research in fatty liver disease to
understand the potential of nCBT as a potential treatment.
BT-001 is part of a new class of PDTs that are increasingly
garnering interest from health care providers and payers. The
Center for Medicare and Medicaid Services recently established new
codes aimed at making it easier for providers to adopt and
integrate these innovative therapies into their care regimens. And
just last week, the bipartisan, bicameral Access to Prescription
Digital Therapeutics Act of 2022 was introduced in Congress. If
passed, this legislation would create a new benefit category within
Medicare to cover and reimburse PDTs. Type 2 diabetes is the
largest cost driver among government payers, including Medicare,
Medicaid, and the Veterans Health Administration, with 40% of type
2 diabetes patients obtaining their insurance through Medicare.
Medicare coverage would represent upside to the company’s financial
projections.
Investor Conference Call and Webcast
Better Therapeutics management will host an investor conference
call and webcast today, March 15 at 8:30 a.m. ET to discuss the
BT-001 data announcement and related corporate updates. The
conference call may be accessed by dialing +1 (833) 945-2463 and
entering the conference ID: 7299550. The live webcast may be
accessed by visiting the event link at:
https://edge.media-server.com/mmc/p/u4w9dpwb. Following the
webcast, a replay of the webcast may be accessed from the Investor
Relations section of the Better Therapeutics corporate website at:
investors.bettertx.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 investigational
mobile applications are intended, if authorized for marketing, 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 the timing and results of the ongoing trial of BT-001 in
patients with type 2 diabetes, Better Therapeutics’ plans regarding
FDA submissions, 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, expectations related
to the interest of healthcare providers and payers in PDTs and
legislative developments affecting PDTs and the outcome of such
developments, 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 for commercial distribution and insurance companies
to reimburse their use, market acceptance of PDTs, 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 definitive proxy statement/prospectus
filed by us on October 12, 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20220315005535/en/
Better Therapeutics Press Contact: Ryan McKenna at Real
Chemistry rmckenna@realchemistry.com
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