Results from the world’s first randomized control study to examine
digital therapeutic smoking cessation programs were presented on May 20th
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
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
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”.
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
*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
*3 Source: Health Effects of Cigarette Smoking, CDC
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/.