CureApp Announces Results from World’s First Randomized Control Study for Digital Therapeutic Smoking Cessation App

TOKYO--(BUSINESS WIRE)-- Results from the world’s first randomized control study to examine digital therapeutic smoking cessation programs were presented on May 20^th at the American Thoracic Society International Conference. The findings demonstrate that CureApp’s nicotine dependence treatment app resulted in an improvement in continuous abstinence rate (CAR) compared to a control group over multiple time points.

Kohta Satake, M.D., M.B.A., M.P.H., Chief Executive Officer of CureApp, Inc. and a respiratory specialized physician says, “Healthcare professionals are challenged to help patients fight against the psychological nicotine addiction alone between clinical visits. CureApp’s digital therapeutics approach is a breakthrough in bridging the gap between clinical visits providing daily support to the patients. We are striving for regulatory and reimbursement approval to deliver the solution as soon as possible.”

The CureApp solution delivers information and educational material through an app that is conveniently on the patient’s smartphone, together with a Carbon Monoxide (CO) monitor for tracking their progress, and a web interface for physicians. CureApp’s system is the first such program to undergo the rigorous testing of Phase III clinical trials. With this confirmation of its efficacy, CureApp’s goal is to use this data to obtain regulatory approval and health insurance coverage in Japan and to expand globally in multiple countries including the United States.

Nicotine dependence

Nicotine dependence is a type of drug dependence; its intensity has been reported to be comparable to that of heroin and cocaine^*1. Smoking is the Number 1 leading cause of preventable death in Japan^*2 and the US^*3.

The Clinical Trial

CureApp’s Phase III clinical trial in Japan was completed in December 2018, and the results were presented at the America Thoracic Society International Conference, ATS 2019 by Dr. Hiroki Tateno, Division of Pulmonary Medicine, Department of Medicine, Keio University, School of Medicine.

The continuous abstinence rate (CAR)* at 9 to 24 weeks, the primary endpoint to verify the efficacy of the CureApp Smoking Cessation, was statistically significantly higher in the trial treatment group than the control group, demonstrating that the CureApp Smoking Cessation contributed to continuous smoking abstinence.

*Continuous abstinence rates at 9 to 24 weeks: Rates of patients who continuously abstained from smoking at 9 to 24 weeks after the start of smoking cessation treatment.

The clinical trial was a multicenter, randomized, prospective, two-group comparative study of the efficacy and safety of the CureApp Smoking Cessation in combination with the standard smoking cessation treatment program in patients with nicotine dependence who visited a smoking cessation clinic. In this clinical trial, the CureApp Smoking Cessation (smartphone application for patients, portable CO checker for patients, and web-based application for physicians) or control device (the control group application) was used for 24 weeks in addition to the standard smoking cessation program.

Of the 584 patients who participated in this trial, 285 patients were assigned to the treatment group using the application for nicotine dependence treatment, 287 patients were assigned to the control group using the control application. Total of 572 patient data was used for analysis. The main evaluation item is “Continuous Abstinence Rate (CAR) at Week 9-24".

Efficacy

The CAR at 9 to 24 weeks, the primary endpoint, was 63.9% (182/285 subjects) in the trial treatment group and 50.5% (145/287) in the control group. The CAR was higher by 13.4% in the trial treatment group, showing a statistically significant difference (95% confidence interval, 1.239-2.424; P = 0.001), with an odds ratio of 1.73. The result demonstrates that the CureApp Smoking Cessation contributed to continuous smoking abstinence.

*1 Source: Kinen no Igaku (Medicine of Smoking Cessation), Japan Medical Association
https://www.med.or.jp/forest/kinen/medical/ (Japanese)

*2 Source: Adult Mortality Attributable to Preventable Risk Factors for Noncommunicable Diseases and Injuries in Japan in 2007, the Ministry of Health, Labour and Welfare
https://www.mhlw.go.jp/topics/tobacco/houkoku/dl/120329_1.pdf (Japanese)

*3 Source: Health Effects of Cigarette Smoking, CDC
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm

About CureApp

CureApp, Inc., a MedTech venture company, engages in research and development to create and market medical programs and devices for disease treatment with advanced software technology and medical evidence. Its pioneering work in digital therapeutics will bring new solutions for a variety of conditions, including nicotine addiction, diabetes, and hypertension amongst others.

Currently, CureApp is jointly developing a nicotine dependence treatment solution with the Division of Pulmonary Medicine, Keio University, School of Medicine (clinical trial completed), a non-alcoholic steatohepatitis (NASH) treatment solution with the University of Tokyo Hospital (clinical trial in progress), and a hypertension treatment solution with Cardiovascular Medicine, Jichi Medical University (clinical trial in progress).

By leveraging the knowledge and findings accumulated in the development of these treatment applications for medical institutions, CureApp provides mobile health programs for private corporations and health insurance associations, including the “ascure Smoking Cessation Program” and “ascure STEPS Lifestyle Habit Improvement Program.” CureApp plans to expand these and other digital therapeutic solutions from Japan to the global market. For more information visit, https://cureapp.co.jp/en/.

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