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Pyramax, produced by Shin Poong Pharm, is on the World Health Organization's list of essential medicines. The medicine that contains active substances such as pyronaridine tetraphosphate and artesunate has been selected for a drug re-creation study to expand its treatment range to COVID-19.
For Phase II clinical trials, 113 mild and moderate patients were divided into a treatment group and a placebo control group to monitor the effects of virus suppression and clinical indicators over a time period of 28 days. As a result, Shin Poong said it did not obtain "statistically significant indicators" because the number of test subjects was small.
Shin Poong said it would go ahead with follow-up clinical trials because some indicators showed the possibility that Pyramax would suppress the coronavirus and reduce the rate of prognosis deterioration. Unexpected significant side effects in safety assessment were not seen in both groups.
"We have confirmed the basis for the virus deterrence effect of Pyramax and the possibility of improvement in overall clinical indicators," the pharmaceutical company said in a statement on July 5, vowing to carry out quick verification through large-scale Phase III clinical trials on approval from the Ministry of Food and Drug Safety.
Citing the growing demand for oral therapy, Shin Poong said that if efficacy and safety are confirmed in third-stage clinical trials, the strength of Pyramax as an early treatment to curb prognosis deterioration and asymptomatic infection can be highlighted.
The COVID-19 pandemic has opened a huge market for vaccines, diagnostic kits and medication. Celltrion's antibody treatment, Regdanvimab (CT-P59), has been approved as South Korea's first treatment for COVID-19. Regdanvimab takes the form of an intravenous injection, but its administration is limited to patients with mild or moderate symptoms in a high-risk group of people.
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