HONG KONG – Tokyo-based Cureapp Inc. has received the Ministry of Health, Labour and Welfare (MHLW)’s green light to manufacture and sell Cureapp SC [Smoking Cessation] Nicotine Addiction Treatment App and CO Checker, its therapeutics app to aid patients who are quitting smoking.

Kohta Satake, CEO of Cureapp, said, “We were able to develop Japan’s first therapeutic app, and the world’s first app treating nicotine addiction, within six years of our founding in 2014. The app receiving the regulatory approval will bring Japanese smokers a new approach to smoking cessation.”

“In order for Cureapp SC to be widely used it needs to be covered by insurance. Cureapp is currently applying for reimbursement under Japan’s universal health insurance system. Once the application is approved, Cureapp will start selling it to medical institutions,” a company spokesperson told BioWorld, with the app expected to be released this year, with pricing currently under discussion.

The app consists of a patient app and a doctor app, as well as a portable CO checker. The patient app, used in conjunction with the checker, allows patients to accurately measure the level of carbon monoxide, a byproduct of tobacco smoke, in their breath. The measurements, and details on the patient’s condition, are in turn passed to medical professionals via the doctor app. The data allows them a better insight into the patients’ response to treatment in between checkups and allows them to adjust the treatment as necessary, thus improving its efficiency.

The app is currently available in Japanese, but Cureapp has started work on an English version. “There are plans to expand into other languages, with Mandarin and Cantonese our top priorities,” the spokesperson said. The company is also looking to launch the app outside Japan and has applied for FDA regulatory approval on top of establishing a U.S. subsidiary. Satake is also eyeing Greater China as a key expansion region due to his time at the Graduate School of Management’s China Europe International Business School, located in Shanghai, and Cureapp is actively seeking partnership opportunities.

MHLW gave its approval following preliminary approvals from the Medical Devices and In-Vitro Diagnostics Working Group as well as MHLW’s Pharmaceutical Affairs and Food Sanitation Council. Data from phase III clinical trials in Japan, conducted from October 2017 to December 2018, showed that the continuous abstinence rate at weeks 9 to 24, the study’s primary endpoint, was statistically significantly higher in the trial treatment group than the control group and demonstrated that the app contributed to continuous smoking abstinence, the company said.

The multicenter, randomized, prospective, two-group comparative study evaluated Cureapp SC’s efficacy and safety in combination with the standard smoking cessation treatment program available at smoking cessation clinics over a 24-week period, with 584 patients taking part.

The success rate of conventional smoking cessation outpatient treatments in Japan remains under 30% at the one-year mark, according to the Fact-finding Survey into Smoking Cessation Success Rates at Authorized Insurance Medical Institutions that Measure Nicotine Dependency Rates’s 2009 survey, highlighting the need for more effective treatments. The MHLW’s own Smoking and Health report also laid out the economic cost, with excessive medical spending and labor loss caused by smoking adding up to around ¥4.3 trillion ($40.51 billion).

Cureapp SC aims to reduce the smoking population and the associated costs with more efficiency. But the app also targets the smokers’ mental addiction. The ubiquity of the smartphone, and thus the app, aims to overcome the physical and time restraints placed on health care professionals in providing therapeutic intervention outside the treatment facility.

Therapeutic apps: a potential new treatment

Therapeutics apps are attracting attention both in Japan and globally as a new form of treatment for various indications. Regulatory bodies in Europe and the U.S. have approved some apps, which are now being prescribed to patients.

“But cases such as ours where regulatory approval has been granted following a strict series of clinical trials remain few and far between. Looking ahead, we will focus our efforts on promoting “app-based therapeutics” as a new method of treatment while continuing to push forward research and development into treatments for various other ailments besides nicotine addiction,” Satake said.

Cureapp is living up to its name, with an active pipeline of new apps in development. The company is jointly developing a nicotine addiction digital therapeutic app with Keio University School of Medicine’s Department of Pulmonary Medicine. Cureapp completed a randomized control trial for this indication in May 2020 and received regulatory authorization for the product’s manufacture and sale in August 2020.

Multicenter phase II trials began in April for a non-alcoholic steatohepatitis (NASH) digital therapeutic jointly developed with The University of Tokyo Hospital. Phase III clinical trials started in December for a hypertension digital therapeutic jointly developed with Jichi Medical University School of Medicine’s Division of Cardiovascular Medicine, and phase I trials are currently underway for an alcohol dependence digital therapeutic app jointly developed with National Hospital Organization’s Kurihama Medical and Addiction Center.

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