KPS BigThink Completes US Exploratory Clinical Trial for Digital Therapeutic Device: "68% of Patients Show Symptom Improvement"

As the government has officially launched the development of digital therapeutics (DTx) utilizing the metaverse, BigThink Therapeutics, which conducted the first exploratory clinical trial of obsessive-compulsive disorder (OCD) DTx in the United States, announced on the 28th that it has produced positive top-line results. BigThink is a bio-subsidiary of KPS, a company listed on the KOSDAQ.

According to KPS, this clinical trial was an exploratory study conducted remotely with a total of 30 patients across the United States during the COVID-19 period. The trial observed the therapeutic effects of using 'Ocefree' for six weeks and the maintenance of treatment effects without device use for four weeks thereafter. The primary endpoint was the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) measuring the severity of obsessive-compulsive symptoms, while secondary endpoints included various indicators measuring anxiety and depression levels.

As a result, 68% of patients showed significant symptom improvement at the 6-week mark of using Ocefree, and among them, 28% demonstrated an improvement exceeding 30% compared to baseline, suggesting the excellent potential of Ocefree in the treatment of obsessive-compulsive disorder, according to the company.

The data on the maintenance effect after Ocefree treatment was evaluated as even more encouraging. Han Mi-kyung, head of BigThink’s DTx division, stated, "We confirmed the efficacy of Ocefree up to the 10th week after six weeks of treatment without device use in the clinical trial. Moreover, patients’ anxiety symptoms significantly improved during the trial, enhancing the device’s utility, while no adverse effects related to the app were reported." She added, "Based on these positive exploratory clinical results of Ocefree, we are finalizing improvements to the app and planning future approval clinical trials."

Earlier, in May last year, BigThink acquired the Korean distribution rights for 'attuneTM,' a mental health treatment for cancer patients, from the U.S. DTx developer Blue Note Therapeutics. Additionally, the app imported from Limbix Health, the developer of the adolescent mental health treatment 'SparkRxTM,' is in the final stages of localization.

Han said, "For attune, we completed localization work in collaboration with the Korean Psycho-Oncology Society and received clinical GMP approval in March to conduct clinical trials. Attune is on the verge of FDA approval in the U.S. this year and is preparing for approval clinical trials domestically as well." It is also known that Limbix’s Spark has successfully completed clinical trials and plans to submit a 510(k) application to the FDA.

She continued, "We will improve the points observed during the exploratory clinical trial of Ocefree to provide new treatment options for patients suffering from obsessive-compulsive disorder. As demand for digital healthcare increases, we will dedicate ourselves to playing a key role in future health management services."

Meanwhile, according to health authorities and related industries, the Ministry of Health and Welfare is preparing technology to manage the mental health of the MZ generation (Millennials + Generation Z) based on mobile and metaverse platforms. This project will begin this year and proceed in stages over three years. The ministry plans to develop mental health measurement indicators and algorithms for depression and anxiety using mobile phone usage data within the year.

This content was produced with the assistance of AI translation services.