NEW YORK--Click Therapeutics announced highlights from a poster presentation at the Annual Meeting of the Society for Research on Nicotine and Tobacco on the recently completed clinical trial of Clickotine®, a Digital Therapeutics program for smoking cessation and the company’s first commercially available product on its platform. These data were from the 6-month post-enrollment follow-up of an 8-week, single-arm clinical trial of Clickotine as a treatment for smoking cessation. All study procedures were IRB approved; data were collected in Amazon S3 with no manual data entry, and access to all data was maximally restrictive, logged and auditable.

At the 6-month mark, 35.3% (n=147) of the 416 participants had achieved 30-day sustained abstinence. This was an increase from the 8-week quit rate where 26.2% (n=109) of participants achieved 30-day sustained abstinence.

Click Therapeutics’ Director of Scientific Affairs, Dr. Brian Iacoviello, who presented the 6-month results at the annual meeting of the Society for Research on Nicotine and Tobacco, said, “These are very encouraging data, especially to observe an increase in a treatment’s efficacy over time during a follow-up period. But, when one considers how Clickotine works, and how engaged Clickotine users remain over time, it is understandable that Clickotine would continue to exert an effect.”

Unlike most smoking cessation applications, the mobile component of Clickotine adheres to the US Clinical Practice Guidelines (USCPG), and follows the CDC’s Best Practices for Comprehensive Tobacco Control Programs. In addition, the platform’s machine learning platform, Clickometrics®, ensures that the program is optimized and personalized to best fit each individual, which is a differentiating factor in the industry.

The commercial version of Clickotine integrates live coaching and direct access to nicotine replacement therapy, which are the two primary offerings in the marketplace. Commercial clients are provided with access to a real-time data analytics portal that includes metrics on engagement, behavior changes, endpoint achievement, and ROI based on projected and realized cost savings.

"We're pleased to report the 6-month results we've obtained with our mobile, patient-centered technology," said David Benshoof Klein, Click Therapeutics’ CEO. "These data position Clickotine as the world's leading smoking cessation program, and support Clickotine as a safe and effective treatment for those who want to quit smoking. The fully digital nature of the program allows Clickotine to be seamlessly integrated into the existing infrastructure of employer, health insurer, and provider systems to significantly enhance or completely replace current smoking cessation services."

A copy of the above referenced abstract can be viewed online through the Society for Research on Nicotine and Tobacco website at SRNT.org. The data presented is also available on the Publications page of the Company’s website at ClickTherapeutics.com.

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.