Komipharm awaits approval for clinical trial design

Market observers are skeptical of Komipharm stocks, as it is still waiting to get approval from the Ministry of Food and Drug Safety for its application to test the Panaphix drug on COVID-19 patients.

On Feb. 26, Komipharm gave an official notice to its shareholders that it has applied to the ministry for a fast-track review of its proposal for clinical phase 2/3 trials of Panaphix, a cytokine storm inhibitor believed to treat pneumonia, for 100 COVID-19 patients.

Its stocks hit the daily maximum hike rate of 30 percent on Korea’s secondary bourse Kosdaq on that day, and experienced an additional upward streak for five consecutive days.

“We wish to raise the confidence of our shareholders by alerting them of our ongoing drug development efforts,” a Komipharm official told The Korea Herald, in explaining its notice.

Since the initial application, Komipharm has submitted additional documents to the ministry.

Under normal circumstances, the MFDS usually takes 30 working days to review clinical trial applications. However, given the urgency of the COVID-19 situation, the authorities have said they may expedite relevant drug development pursuits.

The ministry gave the green light to Gilead Sciences’ remdesivir phase 3 clinical trial application in just four days, but is yet to notify Komipharm.

Korea Exchange (KRX) has warned against unchecked fluctuations in coronavirus-themed stocks without tangible performance results.

The KRX had said it is eyeing stocks that have experienced unnatural surges in trading volumes and prices and will probe if there are irregularities.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)