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Bio company Gemvax & KAEL

Bio company Gemvax & KAEL

(Seoul = Larose.VIP) Reporter Kim Hyun-soo = Gemvax & KAEL, a new drug development company, announced on the 23rd that the Ministry of Food and Drug Safety designated ‘GV1001’, a treatment for progressive supranuclear paralysis (PSP), as an orphan drug in the development stage.

Once designated as an orphan drug, it is subject to expedited review and can receive conditional approval with only phase 2 clinical trials. Various special provisions, such as extension of product approval validity period and market exclusivity, are also applied.

PSP is an atypical Parkinson’s syndrome, and the disease progresses faster than regular Parkinson’s disease and does not respond well to drugs used for Parkinson’s disease.

Gemvax & KAEL expected GV1001 to improve the brain immune environment and reduce inflammation for neurodegenerative diseases such as PSP and Alzheimer’s.

This treatment is currently undergoing phase 2 clinical trials for PSP in Korea, and the phase 2 clinical trial plan was recently approved by the U.S. Food and Drug Administration (FDA).

Gemvax[082270]It also plans to proceed with the overseas orphan drug designation process, including the FDA.

A Gemvax official said, “This designation will be a great help in the challenge of developing the world’s first treatment,” and added, “We will do our best to develop good results in domestic and global clinical trials for PSP patients suffering from a lack of treatment.” said.

hyunsu@yna.co.kr

Report to KakaoTalk okjebo 2024/02/23 13:41 Sent

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