- Better Therapeutics assets include the first FDA-authorized
prescription digital therapeutic for type 2 diabetes, AspyreRx, as
well as development candidates BT-002, BT-003 and BT-004 for
hypertension, hyperlipidemia, and MASH.
- Initial efforts will focus on further development of AspyreRx
to adapt it for the treatment of obesity and to benefit from
Click’s AI-enabled platform as part of Click’s obesity digital
therapeutic in development, CT-181; Click does not plan to
self-commercialize AspyreRx as-is at this time.
- CT-181 will be optimized for combination use with anti-obesity
and diabetes medications such as GLP-1s, including current
injectables and future oral formulations, with the goal of
improving treatment persistence, outcomes, and value.
Click Therapeutics, Inc. (“Click”), a leader in Digital
Therapeutics™ as prescription medical treatments, today announced
plans to accelerate its development initiatives in obesity and
cardiometabolic disease through the acquisition of the assets of
Better Therapeutics, Inc. The assets acquired include AspyreRx
(BT-001), the first FDA-authorized prescription digital therapeutic
for type 2 diabetes, and BT-004, which was recently granted FDA
Breakthrough Device Designation for the treatment of metabolic
dysfunction-associated steatohepatitis (MASH). Other assets are
BT-002, for the reduction of blood pressure in patients with
hypertension, and BT-003, for the reduction of LDL cholesterol in
patients with hyperlipidemia. This acquisition strengthens Click’s
portfolio of innovative digital treatments for patients by
immediately advancing its pipeline in obesity, diabetes and
cardiometabolic diseases, complementing existing assets in
psychiatry, CNS and pain disorders.
Click’s advancement into obesity and cardiometabolic disease is
a culmination of progress over the past few years including the
initiation of CT-181, a prescription digital therapeutic candidate
for obesity. In addition, the company has done extensive research
with patients, providers, and payers to evaluate the evolving needs
in this rapidly growing therapeutic area. A key focus has been
early discovery efforts to identify innovative features, such as
smart titration and personalized side effect management, that can
meaningfully enhance anti-obesity and cardiometabolic medication
outcomes and value.
“There is immense potential in the cardiometabolic space for
next-generation ‘smart’ therapeutics that enhance patient care and
provider capabilities,” said Rich DeNunzio, Chief Commercial
Officer of Click Therapeutics. “The current one-size-fits-all
approach to obesity management can be improved with innovative
digital therapeutics that tailor treatments to individual needs,
leading to improved patient outcomes and the opportunity to create
data-driven contracting models with payers. By collaborating with
pharma, payers, providers and patients to layer these capabilities
onto the latest drugs, we can transform obesity care and enable our
partners to succeed in what is soon to be a highly competitive
market.”
Obesity is a complex, chronic metabolic disease with both
biological and neuro-behavioral drivers. Personalized treatment
plans that consider the individual's biology, psychology, and
environment are crucial for effective management. Digital
therapeutics can offer individual neuro-behavioral treatment,
responsive to each patient, that delivers the comprehensive
approach required to support long-term outcomes. By delivering such
treatment alongside medication, drug-software combination
treatments aim to improve clinical outcomes, enhance the patient
experience and extend persistence on treatment compared to
pharmacotherapy alone. When supported by appropriate clinical
evidence, these benefits may be added directly to drug labels under
FDA’s proposed new framework for demonstrating added clinical
benefit due to the use of software with prescription drugs.1 In
addition, data derived from real-world use of these smart
medications can inform appropriate patient selection, support
value-based contracting, and maximize value for all
stakeholders.
Integration of Better Therapeutics’ intellectual property with
Click’s development plans for obesity is expected to both
accelerate development timelines and yield a best-in-class digital
therapy for chronic weight management. The resulting digital
therapeutic will be optimized for the treatment of obesity in
combination with anti-obesity and diabetes medications such as
GLP-1s, including current injectables and future oral formulations.
It will leverage both AspyreRx’s clinically-validated digital
behavioral therapy, developed over the course of 9 years, and
Click’s AI-enabled platform, which combines advanced engagement
techniques with proprietary digital mechanisms of action to treat
disease. Similar development opportunities in type 2 diabetes,
hypertension, hyperlipidemia and MASH will be enabled by the
integration of Better’s assets with Click’s platform.
“Click can immediately strengthen AspyreRx by combining the
latest engagement technology from our platform with Better’s
therapeutic core. This allows us to efficiently deliver on the
added clinical promise needed to support drug-software combination
products with enhanced labels,” said Han Chiu, Chief Technology
Officer of Click Therapeutics. “We expect the resulting
best-of-both program will earn the long-term loyalty of patients,
enabling superior outcomes and the generation of valuable
real-world data insights for providers and payers.”
Click’s expansion into cardiometabolic disease follows
successful in-house development efforts in the preventive treatment
of migraine (CT-132), and multi-year collaborative development
efforts in major depressive disorder (CT-152) with Otsuka, in
schizophrenia (CT-155, CT-156) with Boehringer Ingelheim, and most
recently, in opioid use disorder (CT-102) with Indivior.
About Click Therapeutics
Click Therapeutics, Inc., develops, validates, and
commercializes software as prescription medical treatments for
people with unmet medical needs. As a leading innovator of Digital
Therapeutics™, we deliver accessible, clinically validated,
FDA-regulated prescription treatments to the smartphone in your
hand. Our treatments are defined by our commitment to applying
technical and scientific rigor and patient-centric design to the
development process. This results in uniquely engaging experiences
that achieve compelling clinical outcomes for patients seeking new
treatment options. We are continuously expanding and refining our
shared platform technologies with novel cognitive, behavioral and
neuromodulatory mechanisms of action and advanced data-driven tools
such as artificial intelligence and machine learning.
Click Therapeutics, in collaboration with Otsuka, developed the
first prescription digital therapeutic authorized by the FDA for
the adjunctive treatment of major depressive disorder symptoms,
Rejoyn™. Digital therapeutics under development on Click’s platform
address diverse areas of therapeutic need, including indications in
psychiatry, neurology, oncology, immunology, and cardiometabolic
diseases.
Consistently named a best place to work, we foster an inclusive,
diverse workforce of innovators, clinicians, scientists,
researchers, designers, technologists, engineers and more, united
in our mission to provide patients everywhere access to safe and
effective prescription digital therapeutics.
For more information, visit www.clicktherapeutics.com and
connect with us on LinkedIn.
AspyreRx - 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.
References
1. FDA. Guidance for Industry. Regulatory Considerations for
Prescription Drug Use-Related Software. Draft; 18 September 2023.
Available at https://www.fda.gov/media/172165/download. Accessed 10
October 2023 (PDURS Guidance).
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version on businesswire.com: https://www.businesswire.com/news/home/20240522194752/en/
Investor Daniel Busby ir@clicktherapeutics.com
Media Jonni Mills pr@clicktherapeutics.com
+1.332.222.4177