Korean digital therapeutics (DTx) makers have not made a single license application since April, according to the regulatory agency.

Noting that the Nos. 1 and 2 DTx had debuted in the domestic market, industry insiders predicted that it would likely take a considerable time for the No. 3 DTx to get approval.

According to the Ministry of Food and Drug Safety, the number of applications for DTx licenses received filed with the ministry remains “zero” as of Monday. The ministry approved two DTx this year -- Aimmed’s Somzz in February and Welt's 'WELT-I' in April.

The successive approvals of DTx have drawn attention to the emergence of a third DTx with indications other than insomnia. However, it is expected to take considerable time for a third device to get a nod.

LifeSemantics, which raised the industry’s expectations for winning approval following Aimmed and Welt, failed to attain the desired results in the confirmatory clinical trial, forcing market watchers to shelve their anticipation.

On Wednesday last week, LifeSemantics unveiled the results of a confirmatory clinical trial of its respiratory rehabilitation software, Redpill Sumteun.

The company sought to demonstrate the superiority of Redpill Sumteun over traditional rehabilitation management in patients requiring respiratory rehabilitation for conditions such as COPD, asthma, and lung cancer.

However, it failed to achieve statistical significance in the primary endpoint of the six-minute walk distance (6MWD) change.

As a follow-up, LifeSemantics has resubmitted the trial plan to the ministry with revised efficacy endpoints and expanded enrollment.

"The main objective of respiratory rehabilitation therapy is to improve physical and emotional well-being in daily life, and significant effects were found in 'average daily steps' and 'Hospital Anxiety and Depression Scale (HADS) indicators,'" a company official said. "We plan to verify these effects in subsequent clinical trials further."

While no other products are close to approval, DTx development fervor remains hot. As of Aug. 30, 47 DTx devices had won approval for clinical trials -- 26 exploratory and 21 confirmatory trials.

"During the Covid-19 pandemic, it would have been difficult to recruit patients," said Lee Jeong-rim, head of the Medical Device Review Department at the National Institute for Food and Drug Safety Evaluation (NIFDS), at a meeting with journalists on Monday. “Fourteen products got a nod for confirmatory clinical trials in 2021 and 2022. I think those trials must have progressed to some extent. The ministry hopes to see more license applications by the end of the year."

Lee noted that the ministry has published six guidelines for approving clinical trial plans for DTx, and companies have obtained approvals for clinical trials according to these guidelines.

Stressing that the ministry has a lot of preparations for the approval, the official said. “When the new devices win licenses will depend on how quickly they complete clinical trials.

According to the regulator, many of the products approved for confirmatory clinical trials are aimed at improving symptoms of neurological and psychiatric conditions, including generalized anxiety disorder, mild cognitive impairment, alcohol and nicotine disorders, depression, and eating disorders, through cognitive behavioral therapy. Besides, some products undergo confirmatory clinical trials to improve symptoms, such as respiratory rehabilitation, vision disorders, and tinnitus.

Officials also showed expectations about DTx related to drug addiction treatment. At the opening ceremony of the Addiction Rehabilitation Center in South Chungcheong Province in July, Minister of Food and Drug Safety Oh Yoo-kyung revealed that her ministry and the Ministry of Science and ICT were developing a DTx for treating drug addiction among adolescents.

An interagency project group is currently carrying out the research project. Besides the two ministries, the Ministry of Trade, Industry and Energy and the Ministry of Health and Welfare co-launched the group.

"The Food and Drug Safety Ministry is also monitoring the development status and preparing for a quick approval,” Lee added.