Shinpoong Pharmaceutical's COVID-19 Treatment 'Piramax' Fails Phase 3 Clinical Trial

Shinpoong Pharmaceutical's malaria treatment drug 'Pyramax (active ingredients pyronaridine phosphate and artesunate)', developed as a COVID-19 treatment, failed to demonstrate efficacy in Phase 3 clinical trials.

Shinpoong Pharmaceutical 'Pyramax'

On the 18th, Shinpoong Pharmaceutical announced through a public disclosure that after receiving the top-line data from the Phase 3 clinical trial of Pyramax, no difference was found between the experimental group (Pyramax group) and the placebo group in the primary efficacy endpoint, which was the "proportion of subjects requiring hospitalization or who died due to COVID-19 infection."

This clinical trial was conducted on a total of 1,420 participants across six countries globally, starting with South Korea's Ministry of Food and Drug Safety in July 2021, including the UK, Argentina, Chile, Colombia, and Poland. The experimental and placebo groups were randomly assigned in a 1:1 ratio, with 710 participants in each group. The trial lasted a total of 29 days, during which efficacy and safety evaluations were continuously conducted.

However, in this trial, no deaths occurred in either group, and only one participant in the placebo group required hospitalization. Ultimately, the primary efficacy endpoint?the proportion of subjects hospitalized or deceased?was 0% in the experimental group and 0.14% in the placebo group, failing to statistically prove the superiority of Pyramax over placebo. The company explained, "Due to the Omicron variant surge and high vaccination rates resulting in a low incidence rate (hospitalization, oxygen therapy, death), a statistically significant difference could not be confirmed."

Regarding safety, the incidence rates of serious adverse events (SAE) and serious adverse drug reactions (SADR) were low and showed no difference between groups. SAE was recorded at 0.43% in the experimental group and 0.57% in the placebo group, while SADR was 0.14% in both groups. No statistically significant differences were observed here either.

A Shinpoong Pharmaceutical official stated, "Secondary efficacy endpoints evaluating the impact on clinical symptom resolution and viral load, as well as subgroup analyses considering baseline demographic and disease-related characteristics between groups, are currently underway for detailed efficacy and safety analysis," adding, "Based on these results, we will decide on the future development direction."

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