Study Conducted with Arizona Liver Health Met
Primary Endpoint and Established Proof-of-Concept for Prescription
Digital Therapy Platform to Improve Disease Biomarkers in NAFLD and
NASH Patients
Company Intends to Apply for Breakthrough
Device Designation with FDA
Company to Host Conference Call and Webcast
Today at 8:30 a.m. ET
Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital
therapeutics (PDT) company developing cognitive behavioral therapy
(CBT) to address the root causes of cardiometabolic diseases, today
announced positive topline results of the first-ever study
evaluating the feasibility of using a prescription digital
therapeutic to reduce liver fat and improve liver disease
biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD) and
Nonalcoholic Steatohepatitis (NASH).
The study included a cohort of 22 patients with NAFLD and NASH
and used Magnetic Resonance Imaging - Proton Density Fat Fraction
(MRI-PDFF) scans, a validated proxy for liver biopsies, to monitor
changes in liver fat. Changes in a range of exploratory liver
biomarkers were also assessed. Currently, there is no FDA approved
treatment for these conditions, which affect approximately one in
four Americans and cause approximately $100 billion in direct
medical cost annually. And while some drug candidates are in
various phases of research and development, they often present side
effects that could limit their utility in patients, if
approved.
“With approximately 90 million Americans affected by NAFLD,
fatty liver disease is a public health crisis that has hit epidemic
levels. Because there are currently no FDA approved therapies
available to treat these patients, we need to evaluate every
possible option to reduce the burden of this condition – and in
this study we have found positive topline signals across multiple
disease biomarkers for a potential new option in our fight against
NAFLD and NASH,” said Mazen Noureddin, MD, Director of the Houston
Liver Institute and who served as the Senior Scientific Advisor for
the LivVita Study. “Since the cause and progression of these
conditions are linked to behavioral factors like diet and activity
level, the utilization of a prescription digital therapy that
targets these behaviors is compelling and appears to have the
potential to make a real difference in this costly disease.”
The LivVita Study met its primary endpoint, showing a
statistically significant positive signal with an average relative
reduction in MRI-PDFF of 16% (p=0.01) in the intent-to-treat
population (N=19). Additional highlights include:
- A statistically significant mean reduction in Alanine
transaminase (ALT) of -17 IU/L (p=0.002)
- A statistically significant mean change in FAST Score of 20%
(p=0.01)
- No severe adverse events or device related adverse events
- High engagement and patient satisfaction with treatment, with
Net Promoter Score of +75 and 94% of subjects still using the app
after 90 days
“The results seen in the LivVita Study give us confidence that
there is merit in further development of treatments for NASH and
NAFLD that leverage digital therapies and CBT techniques,” said
Naim Alkhouri, MD, Director of the Fatty Liver Program at Arizona
Liver Health and Principal Investigator of the study. “We have long
understood that making real changes to certain behaviors can result
in slowed progression of this disease, but we have not had a
reliable, scalable way to deliver the support people need to make
them. If we can use smartphones as a delivery mechanism for
meaningful therapy, it should certainly become a tool we lean on as
we help patients live with these chronic conditions.”
The study relied on Better Therapeutics’ CBT platform, which has
been developed with the intention of helping patients with
cardiometabolic diseases – including NASH and NAFLD – access a
tailored treatment that leverages CBT techniques to address
underlying causes of these diseases and help them make sustainable
behavioral changes. This platform has already shown progress
elsewhere, leading to the submission of a de novo classification
request for BT-001, Better Therapeutics’ prescription digital
therapy for type 2 diabetes, currently under review by the FDA.
“In our initial work on BT-001, we have already seen indications
that our novel form of CBT delivered through a prescription digital
therapeutic may help with cardiometabolic conditions. The
encouraging early results from our work with fatty liver disease
continues to build that body of evidence,” said Mark Berman, MD,
CMO of Better Therapeutics. “As we move towards 2023 and the
anticipated launch of our first digital therapeutic, pending FDA
authorization, we are more confident than ever in the promise of
this approach to treating these conditions.”
Better Therapeutics intends to publish these data in a
peer-reviewed journal, apply for breakthrough device designation
with the FDA, and potentially seek a partner to accelerate
development of a NAFLD/NASH specific PDT.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, December 8, 2022, at 8:30 a.m. ET / 5:30 a.m. PT to review
the topline results from the LivVita Study. To access the
conference call, please register at:
https://register.vevent.com/register/BI2e2fa3ed900e4fa49b51635011507657.
Upon registering, each participant will be provided with call
details and access codes. All participants are encouraged to join
10 minutes prior to the start time. The live webcast may be
accessed by visiting the event link at:
https://edge.media-server.com/mmc/p/xpog3h3b. A replay of the
webcast may be accessed from the Presentations & Events page in
the Investors 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
(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 the delivery of CBT and /or PDTs by Better Therapeutics
to address the root causes of NAFLD, NASH, type 2 diabetes and
other conditions, Better Therapeutics’ plans regarding FDA
submissions, expectations related to the potential benefits of
BT-001 and CBT and their potential treatment applications and the
limitations of other drug candidates to address the treatment of
NAFLD and NASH, Better Therapeutics’ plans regarding the research
and advancement of its PDTs for NAFLD, NASH and additional
treatments, plans and expectations regarding the commercialization
of BT-001, if approved, 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 Better Therapeutics’ quarterly report on
Form 10-Q for the quarter ended September 30, 2022 filed with the
Securities and Exchange Commission (SEC) on November 14, 2022, and
those that are included in any of Better Therapeutics’ subsequent
filings with the SEC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221208005371/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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