CureApp Announces Results from World’s First Randomized Control Study for Digital Therapeutic Smoking Cessation App
Tokyo, Japan – May 30, 2019 – 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 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
*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
<https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm>
<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/.
Contact:
For US media
Joy Scott, CEO, Scott Public Relations
E-mail: Joy@scottpublicrelations.com
Phone: 818.610.0270
For media from other countries
Nanako Daime, Public Relations Manager, CureApp, Inc.
E-mail: nanako.daime@cureapp.jp