Pivotal trial established use of AspyreRx
alongside standard of care demonstrating clinically meaningful and
statistically significant reduction in HbA1c leading to FDA
authorization
In a subgroup analysis, the use of AspyreRx and
GLP-1 receptor agonists showed substantially greater A1c reductions
than the previously reported results of the entire trial
population
Recent draft guidance from the FDA indicates
the intent to consider the combined effectiveness of
pharmaceuticals and digital therapeutic solutions when making drug
labeling decisions
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing prescription digital therapeutics (PDTs) to treat
cardiometabolic diseases, today announced top-line findings from a
recent subgroup analysis of AspyreRx (formerly BT-001) in its
pivotal trial for type 2 diabetes (T2D). The analysis reveals that
adjunctive use of AspyreRx with standard of care, including GLP-1
receptor agonists (GLP-1), leads to a substantially greater
clinical improvement compared to control participants who did not
incorporate AspyreRx into their regimen. The subgroup analysis,
involving approximately 160 participants on GLP-1s randomized to
the active and control arm of the study, exhibited an average
reduction in HbA1c of 0.7% at 90 days, between the two groups. This
exceeds the results of the entire BT-001 pivotal trial population,
where AspyreRx outperformed the standard of care control arm by
0.4%. Both reductions were statistically significant when compared
to the corresponding control group.
In addition to improvements in HbA1c at day 90, participants
that were on both GLP-1 medications and AspyreRx also showed
greater HbA1c reduction, greater weight loss, and utilized fewer
medications at day 180 when compared to participants on GLP-1
medications without AspyreRx. The data for this subgroup analysis
are being submitted for peer-reviewed publication.
“The findings from this subgroup analysis support that patients
receiving GLP-1 derive additional additive benefit from intensive
behavioral modification provided by AspyreRx. Despite the important
benefits of GLP-1 agents, patients receiving them may continue to
struggle to achieve glycemic control for multiple reasons including
therapeutic inertia and side-effects associated with these drugs.
This new data underscores the importance of recognizing that
behavior modification is a critical foundational component of
diabetes treatment, including for patients taking GLP-1s. A
comprehensive management approach that combines effective
pharmacotherapy along with effective digital therapeutics to
support patients in making and sustaining behavioral change appears
to be an optimal approach to achieving treatment goals,” said Marc
Bonaca, MD, Executive Director of CPC Clinical Research, providing
independent scientific analysis for the trial.
As previously reported, the BT-001 pivotal trial, the largest
randomized controlled study ever conducted of a digital therapeutic
to evaluate glycemic response in participants with T2D, met both
its primary and secondary endpoints demonstrating statistically and
clinically meaningful reductions in HbA1c over the control group
receiving standard of care. The results achieved were sustainable
and improved between day 90 and day 180 of the trial, demonstrating
that AspyreRx has the potential to deliver meaningful, durable
improvements in blood sugar control for a complex range of patients
with T2D already on blood sugar lowering medications.
In addition, exploratory data revealed a host of cardiometabolic
improvements alongside reduced medication and healthcare
utilization in comparison to the control group, supporting the
potential for AspyreRx to improve the overall health of patients
with T2D and potentially reduce increasingly costly interventions
associated with the progression of the disease. A cost
effectiveness analysis, which was part of a broader Health
Economics and Outcomes Research (HEOR) conducted by Better
Therapeutics, indicates that the utilization of AspyreRx may not
only be more effective than standard of care alone but may also be
less costly for payers.
The new subgroup analysis data may be particularly relevant in
the context of recent draft guidance from the FDA, titled
'Regulatory Considerations for Prescription Drug Use-Related
Software,' released in September, which provides clarity about the
agency’s views and intent to consider the combined effectiveness of
pharmaceuticals and digital therapeutic solutions when making drug
labeling decisions.
"The FDA’s draft guidance opens up the possibility of expanding
drug labeling to include the increased benefits patients may
experience while also using PDTs. Strengthened drug labeling then
has the potential to raise awareness about the concurrent benefits
of drugs and PDTs, which enables providers to improve clinical
outcomes. This differentiation may be particularly relevant within
the highly competitive GLP-1 market. In this multi-billion-dollar
category, PDTs like AspyreRx offer the chance to demonstrate added
value by showing increased effectiveness of GLP-1 agents with a
digital therapeutic," remarked Frank Karbe, CEO of Better
Therapeutics.
RCT Trial Design
The BT-001 pivotal trial was an open-label, randomized,
controlled trial designed to evaluate the efficacy and safety of a
digitally delivered CBT approach among a diverse, nationally
representative group of patients with difficult to treat T2D. 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 included using a “Standard of Care” comparison, as
well as not constraining patients to a specific medication profile
and not incentivizing patients to use the BT-001 therapy.
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.
About AspyreRx
AspyreRx (fka BT-001) was granted marketing authorization by the
U.S. Food and Drug Administration (FDA) in July 2023 as the first
prescription-only digital behavioral therapeutic device delivering
a novel form of cognitive behavioral therapy (CBT) via smartphone
to treat adults with type 2 diabetes (T2D). AspyreRx is backed by
robust data demonstrating clinically meaningful and sustained
reduction in HbA1c as well as improvements in other markers of
cardiometabolic health when used up to 180 days. Using proven
techniques that target the underlying psychological, behavioral,
and cognitive factors that sustain or worsen T2D, AspyreRx is a
self-paced, engaging experience that patients can access
anytime/anywhere. It is prescribed by a healthcare provider in
90-day increments, with proprietary CBT delivered digitally in a
weekly step-by-step process. Through interactive therapy lessons,
skill-building modules, weekly goal setting and tracking, patients
connect changes in behavior to improvements in blood sugar and
other biometrics. Each step in the experience builds on the prior
to enable and reinforce cognitive restructuring, building the
emotional resilience and acceptance needed to make enduring
changes.
Indications for Use
AspyreRx is a prescription-only digital therapeutic device
intended to provide cognitive behavioral therapy to patients 18
years or older with type 2 diabetes. The device targets behavior to
aid in the management of type 2 diabetes in patients who are under
the care of a healthcare provider. AspyreRx provides cognitive
behavioral therapy as a treatment that should be used adjunctively
with standard of care.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics
company developing a novel form of cognitive behavioral therapy to
address underlying factors that sustain or worsen cardiometabolic
diseases. The Company has developed a proprietary platform for the
development of FDA-regulated, software-based solutions for T2D,
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 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 Better Therapeutics’ expectations related to the efficacy
and potential benefits of PDTs, including AspyreRx and CBT and
their potential treatment applications and their ability to improve
clinical outcomes, beliefs regarding the importance of behavior
modification and comprehensive management approaches in diabetes
treatment, statements related to recent draft guidance from the FDA
and the potential of labeling to drive improved awareness of PDTs,
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, including
AspyreRx, the risk that the results of previously conducted studies
will not be interpreted favorably by the FDA or repeated or
observed in ongoing or future studies involving Better
Therapeutics’ 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 June 30, 2023
filed with the Securities and Exchange Commission (SEC) on August
9, 2023, and those that are included in any of Better Therapeutics’
subsequent filings with the SEC.
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version on businesswire.com: https://www.businesswire.com/news/home/20231011709752/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams info@bettertx.com
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