Shin Poong Pharmaceutical said Monday that it has presented the topline results of its phase 2 study using Pyramax, its antimalarial drug, in treating Covid-19.
The study, a placebo-controlled, randomized, double-blind trial, aimed to evaluate the efficacy and safety of Pyramax in Covid-19 patients with mild to moderate disease severity.
The study examined virological clearance and clinical outcomes over 28 days for patients enrolled in a Pyramax treatment group or a placebo group. It recruited 113 patients from 13 clinical sites in Korea, with an average age of 52 years, including 100 patients with mild Covid-19 symptoms.
The company failed to meet the primary endpoint, which was the proportion of patients with virological clearance for Covid-19 based on reverse transcription-polymerase chain reaction (RT-PCR) diagnostic testing, but stressed that recent results showed the validity of the cutoff values measured with RT-PCR diagnosis to determine a negative virus status.
“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 10,” the company said. “Such a result was in contrast to the placebo group, which showed incomplete clearance after 28 days.”
While the trials failed to reach statistical significance for the overall population, in patients with infectious virus load in the top half of the population studied, there was a 2.8-fold significant reduction of virus favoring the Pyramax-treated group over placebo, the company added.
Shin Poong Pharma stressed that concerning clinical outcomes, the proportion of patients who underwent hospitalization, oxygen therapy, additional organ support, or worsening of symptoms leading to serious conditions or death was 55.4 percent lower in the Pyramax-treated group compared with the placebo group.
However, the company noted that the results were not statistically significant due to the small sample size.
“The company saw a more pronounced trend for improvement for the high-risk patient group where the proportion of patients with severe clinical outcomes was 74.3 percent lower in patients treated with Pyramax compared to those in the placebo-treated group,” it said.
In addition, according to the National Early Warning Score (NEWS), widely used to determine the degree of illness and therefore the necessity for prompt critical care intervention, the proportion of patients with worsening of symptoms was 34.9 and 35.7 percent lower than the Pyramax-treated group in the overall population and patients with high-risk compared to the placebo-treated group, it added.
There were no deaths in the Pyramax-treated group in the full analysis set, while there was one death in the placebo-treated group, the company noted.
Regarding the safety of Pyramax in the treatment of Covid-19, the percentage of patients with adverse events was 40.4 percent in the Pyramax-treated group compared with 48.3 percent in the placebo-treated group, which was not statistically significant.
Apart from pneumonia due to the progression of the disease, the most common adverse events included nausea, dyspepsia, headache, and diarrhea.
There were no SUSARs (Suspected Unexpected Serious Adverse Reactions), which, in turn, suggested that Covid-19 patients tolerated Pyramax well.
“The phase 2 clinical trial suggests a possible role for Pyramax in suppressing the virus and improving clinical outcomes in patients with Covid-19,” a company official said. “As the nature of the phase 2 study was exploratory, and the sample size was small, the company failed to achieve statistical significance in the overall population.”
The company plans to evaluate the potential role of Pyramax in the management of Covid-19 in a large-scale Phase 3 clinical trial, he added.
The official stressed that the phase 2 study included mild and moderate cases of COVID-19 with patients who have been non-hospitalized or hospitalized but did not require oxygen therapy.
“Recently, global needs for oral medication for outpatients have increased,” he said. “If the company manages to confirm the efficacy and safety for Covid-19 through a phase 3 study, Pyramax may provide a promising early treatment for Covid-19 that would reduce the number of patients that progress to more severe disease and may also help reduce viral transmission.”
Based on the phase 2 study results, Shin Poong plans to apply for an investigational new drug (IND) approval from the Ministry of Food and Drug Safety in early July to commence a large-scale clinical trial for Pyramax, he added.