KPS Subsidiary BigThink Receives IRB Approval for US Clinical Trial of Domestic Digital Therapeutic 'Ocefree'

[Asia Economy Reporter Jang Hyowon] Big Think Therapeutics, a subsidiary of KPS, announced on the 26th that it received approval from the US IRB (Institutional Review Board) for the exploratory clinical protocol of the obsessive-compulsive disorder (OCD) digital therapeutic (DTx) 'OC FREE' on the 23rd (local US time).

Han Migyeong, CEO of Big Think, said, "This IRB approval is the first US clinical approval for a domestically developed digital therapeutic," adding, "We plan to complete patient recruitment for the clinical trial by the end of the year."

She continued, "Our goal is to complete the pivotal clinical trial by 2024 after the exploratory trial and obtain approval from the US Food and Drug Administration (FDA)."

The exploratory clinical trial, which will last a total of 10 weeks, is scheduled to be conducted in three regions within the US, including research institutions specializing in mental and neurological disorders located in New York and Ohio. It will involve 30 OCD patients aged 18 or older, with 6 weeks of treatment followed by 4 weeks of observation.

CEO Han stated, "Before the IRB approval, we received an official response from the FDA through a Pre-Submission meeting in January this year," and added, "Since this exploratory clinical trial reflects the FDA's feedback, we expect it to demonstrate clearer efficacy."

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