BigThink "US Digital Therapeutics Investor Limbix Receives FDA Emergency Use Authorization"

[Asia Economy Reporter Jang Hyowon] BigThink Therapeutics (BIXINK THERAPEUTICS), an investor in the U.S. digital therapeutics developer Limbix Health, Inc., has received 'Emergency Use Authorization' from the FDA. This authorization is part of the FDA's policy implemented during the COVID-19 crisis to assist in the treatment of mental disorders.

According to BigThink, a subsidiary of KPS, on the 7th, Limbix's depression treatment 'SparkRx' successfully completed exploratory and remote clinical trials targeting children and adolescents aged 13 to 22, and received FDA emergency use authorization based on safety and efficacy data. Limbix is currently conducting confirmatory clinical trials for full FDA approval and product commercialization.

During the emergency use authorization period, SparkRx will be prescribed free of charge by experts such as pediatricians in accordance with FDA regulations. Limbix plans to collect real-world data through these prescriptions to support research and commercialization.

BigThink previously invested $1 million (approximately 6% equity stake) in Limbix around May last year. At that time, Limbix successfully completed a $9 million Series A funding round from prominent investors including GSR Venture in the U.S.

Currently pursuing Series B funding, Limbix presented the exploratory clinical trial results of SparkRx at the 2021 American Academy of Pediatrics conference on the 4th, and plans to obtain full FDA approval in the second half of next year based on these results.

Han Migyeong, CEO of BigThink, stated, "We are discussing additional Series B investment in Limbix," and added, "We are also reviewing the possibility of acquiring domestic distribution rights for SparkRx."

Meanwhile, BigThink is conducting FDA clinical trials for the first time in Korea following approval of the exploratory clinical trial protocol by the U.S. IRB (Institutional Review Board) for its self-developed obsessive-compulsive disorder (OCD) digital therapeutic 'OC FREE.' BigThink's exploratory clinical trial will be conducted in the form of 6 weeks of treatment and 4 weeks of observation targeting OCD patients.