NeuroVenti, IND approval for phase 2 clinical trial in Korea for ASD t…
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Neuroventi (CEOs Shin Chan-young and Seo Dong-cheol) announced on the 15th that it has received approval from the Ministry of Food and Drug Safety for a phase 2 clinical trial plan (IND) for 'NV01-A02', which is being developed as a new drug to treat autism spectrum disorder.
This clinical trial is a multi-center clinical trial in which seven domestic medical institutions, including Seoul National University Bundang Hospital, participate in a total of 105 children aged 6 to 15 years who have been diagnosed with autism spectrum disorder.
The candidate substance, NV01-A02, is a chewable pill that is to be taken for 8 weeks and its safety and effectiveness will be compared and evaluated through randomization with a placebo (fake drug).
NV01-A02 is a drug that precisely regulates specific neurotransmitter receptors related to improving sociality and stereotyped behavior and has already been clinically confirmed to be safe.
Shin Chan-young, CEO of Neuroventi, said, “As we have secured sufficient scientific evidence through various animal experiments and have been preparing for phase 2 clinical trials for several years, our goal now is to shorten the period required for clinical trials.” He showed great confidence in the successful outcome.
The company expected to be able to show the first world-class clinical results that improve social skills, which was the most difficult treatment area for autism spectrum disorder.
Neuroventi is currently in the final stage of attracting Series B investment, and in addition to conducting this phase 2 clinical trial, it plans to accelerate global clinical trials for Fragile
Reporter Jeong Hee-young, Money Today Broadcasting MTN