April 20, 2024

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[THE INVESTOR] South Korea’s biotech firm Mezzion Pharma said on Dec. 27 that its investigational new drug application has been cleared by Korean health authorities for phase 3 efficacy and safety trials for the treatment of patients with single ventricle heart disease.

The IND clearance by the Ministry of Food and Drug Safety came on the heels of the late-stage clinical study on the use of udenafil, originally developed as an erectile dysfunction drug, as a single functional ventricle treatment in the US which started in August.


 

Mezzion Pharma CEO Park Dong-hyun

“The clinical programs will gather further momentum by conducting them in Korea also at the same time,” Mezzion Pharma said in a press release.

This randomized, double-blind, placebo-controlled clinical trials will evaluate the safety and efficacy of orally administered udenafil in adolescents with a single functional ventricle who had previously undergone Fontan surgical palliation.

The condition affects about 29,000 people in the US and 3,000 people in Korea, according to the drug maker.

The clinical program for this orphan drug indication is using protocols developed by Pediatric Heart Network which is funded by National Heart Lung and Blood Institute.

By Park Han-na (hnpark@heraldcorp.com)