South Korea’s Ministry of Food and Drug Safety said on Monday it has started regulatory review of Chong Kun Dang (CKD)’s pancreatitis drug Napabeltan (nafamostat mesylate) 50㎎ to add a potential indication for the treatment of coronavirus symptoms.

If approved, Napabeltan will become the country’s second Covid-19 cure following Rekirona (regdanvimab), Celltrion’s neutralizing antibody therapy, which was approved last month.

Last year, CKD filed for emergency use authorization of Napabeltan with the ministry in parallel with approval for its Phase 3 trial after completing a Phase 2 study of Napabeltan in 104 high-risk patients with severe symptoms in Russia.

In the Phase 2 study, 61.1 percent of patients treated with Napabeltan for 10 days achieved recovery, demonstrating superiority to the standard therapy arm where only 11.1 percent achieved recovery.

After a designed follow-up period of 28 days, 94.4 percent of patients in the Napabeltan group achieved recovery versus 61.1 percent in the comparator group.

Safety-wise, four deaths were reported in the standard therapy group but there was no death in the Napabeltan group.

CKD’s Phase 3 study aims to evaluate the drug in some 600 high-risk patients with severe symptoms at more than 10 centers across Korea, including Seoul National University Hospital. A global clinical trial will be conducted to ensure fast patient enrollment.

The company expects the drug’s unique mechanism of action to respond to even mutants of Covid-19 that are evolving globally. Napabeltan would be the only proven treatment option in the treatment of high-risk patients with severe symptoms if it is approved. Rekirona was approved for the treatment of high-risk patients with mild to moderate symptoms.

The ministry is applying a fast-track review program to coronavirus cures and vaccines, cutting the timeframe from six months to less than 40 days.

By Pulse

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