Shin Poong Pharmaceutical has reported that its antimalarial drug, Pyramax, failed to demonstrate statistical significance for the treatment of Covid-19 in the overall population in a Phase II study.
The placebo-controlled, randomised, double-blind trial analysed the efficacy and safety of Pyramax in subjects with mild-to-moderate Covid-19, Korea Biomed reported.
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It enrolled a total of 113 subjects with an average age of 52 years, at 13 clinical sites in Korea. Of these participants, 100 had mild Covid-19 symptoms.
Virological clearance and clinical outcomes after 28 days of enrolment into the Pyramax treatment arm or a placebo arm were assessed in the trial.
The proportion of subjects attaining virological clearance for Covid-19 as per reverse transcription-polymerase chain reaction (RT-PCR) diagnostic test was the trial’s primary goal.
The trial failed to meet this goal, showing no statistical significance owing to the small number of participants.
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By GlobalDataShin Poong noted that the data from the trial demonstrated the validity of the cut-off values evaluated with the RT-PCR test to establish a negative status of the SARS-CoV-2 virus.
Shin Poong Pharmaceutical was quoted by the news agency as saying: “For infectious viral load, the analysis of the high-risk patient subgroup, who had at least one risk factor for severe illness, showed complete viral clearance in the Pyramax-treated group at day ten.
“Such a result was in contrast to the placebo group, which showed incomplete clearance after 28 days.”
Furthermore, in subjects with infectious virus load in the top half of the population analysed, a 2.8-fold decline of the virus was observed on receiving Pyramax versus placebo.
The proportion of subjects who require hospitalisation, oxygen treatment, organ support or had worsening symptoms, leading to serious disease or death, was 55.4% lesser in the treatment arm compared with the placebo.
In the high-risk subjects, a trend of 74.3% reduction in severe clinical outcomes was observed in those receiving Pyramax compared to placebo.
Shin Poong intends to seek investigational new drug (IND) approval from the South Korean Ministry of Food and Drug Safety to advance Pyramax into a large-scale Phase III clinical trial for Covid-19 treatment.
