NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, announced the launch of Software-Enhanced Drug™ therapies, part of a new product offering called Click SE™. With this launch, Click Therapeutics is pioneering a new prescription digital therapeutic product category in response to increasing interest in U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS).
The Click SE™ offering combines Click’s patent-protected and clinically validated digital therapeutic technology with pharmacotherapy to create Software-Enhanced Drug™ treatments. These innovative combination therapies are designed to target the unique needs of a specific medication and patient population to deliver added clinical benefit. Leveraging Click’s proprietary AI-enabled platform and deep experience developing prescription digital therapeutics with global pharmaceutical innovators, Click SE™ enables pharma to create “SE” (software-enhanced) formulations of pipeline and marketed drugs with the potential to offer enhanced safety or efficacy to patients.
“The launch of Click Therapeutics’ new offering, Click SE™, brings a new level of clinical rigor to the industry that separates Software-Enhanced Drug™ therapies from other PDURS solutions,” said David Benshoof Klein, founder and CEO of Click Therapeutics. “Enabled by our existing best-in-class digital therapeutics platform and experience developing software as a medical device, Click Therapeutics is optimally positioned to begin the development of software-enhanced versions of both in-development and marketed drugs today, offering a new source of value to our pharma collaborators and the patients they support.”
The introduction of Click SE™ builds on the company’s continued leadership in prescription digital therapeutics. Click recently announced that CT-132, Click’s investigational prescription digital therapeutic for the preventive treatment of migraine, met the primary endpoint for the reduction of monthly migraine days (MMDs) in its pivotal trial. At the end of the 12-week treatment, participants treated with CT-132 experienced a significant reduction in MMDs of about 3.0 days, decreasing from a baseline of 7.8 to 4.5 days. Almost twice as many participants reported improvement on the Patient Global Impression of Change using CT-132 vs. sham. In both this pivotal trial and in a related CGRP inhibitor bridging study, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated. Therefore, these clinical data provide information not only on benefit to patients, but importantly added clinical benefit of software plus drug compared to drug alone. Click SE’s software-enhanced drug therapies will be developed with this same level of rigor in an effort to demonstrate additional clinically meaningful benefit from the use of drug and software together.
“Soon, each drug could have a ‘smart’ dosage that combines a highly validated, fully digital therapeutic with traditional pharmacotherapy – a software-enhanced drug,” said Han Chiu, chief technology officer of Click Therapeutics. “Our Click SE™ products will be ‘smart’ in this way. They will be designed to respond and adapt to patients, whether through personalized neuromodulatory interventions, responsive side effect management, or adaptive dose titration with the goal of enhancing overall adherence and efficacy.”
The FDA draft guidance on PDURS includes information on how software can support added ‘clinically meaningful benefit’ claims using evidence from adequate and well-controlled clinical studies on the use of software plus drug compared to drug alone. These provisions could enable a new standard of care where physicians will be able to prescribe “SE” versions of drugs that can improve patient outcomes. These combination therapies are poised to bridge gaps in care, increase access to treatment, and safely treat disease for millions of patients.
“The immense value that software-enhanced drugs can offer to patients means pharmaceutical company pipelines could soon be digitized, and evaluated by prescribers, payers, and investors not only on the basis of their molecular assets but also for those assets’ digital counterparts. This in turn would dramatically transform the healthcare industry as we know it,” said Shaheen Lakhan, MD, PhD, chief medical officer of Click Therapeutics. “I believe it will be routine for providers to consider whether to prescribe their patient the regular or software-enhanced “SE” version of a drug, much like they make a decision today whether to prescribe an immediate release or “XR” extended release version. This new approach adds meaningful clinical value for patients and eases access to adjunctive non-pharmacological care.”
To learn more, visit the dedicated Click SE™ website at https://discover-click.se.
About Click Therapeutics
Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease.
Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click’s platform are regulated, clinically validated prescription mobile applications that can address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases.
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™. In October 2024, in response to FDA guidance on prescription drug use-related software (PDURS), we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients.
Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.
