Breakthrough in medical discovery sees potential role of Pyramax in the management of COVID-19 in the country

Published July 9, 2021, 5:44 PM

by Enzo Luna

The world needs a potent treatment that can eradicate and stop the spread of COVID-19. This is where medical breakthroughs and studies step in. With continuous innovation in the medical field, we will one day find a powerful medication that can fight the virus.

Results of recently completed Phase II study in Korea of Pyramax saw the topline safety and efficacy for COVID-19 patients who have been non-hospitalized or hospitalized but did not require oxygen therapy.

A Shin Poong Pharm. Co., Ltd. official said, “the Phase II clinical trial suggests a possible role for Pyramax in suppressing the virus and improving clinical outcomes in patients with COVID-19. As the nature of the Phase II study was exploratory and the sample size was small, statistical significance was not achieved in the overall population. The potential role of Pyramax in the management of COVID-19 will be evaluated in a large-scale clinical trial.”

Shin Poong Pharm. Co., Ltd. is engaged in synthesizing, manufacturing and distribution of pharmaceutical products and ingredients based in South Korea. The company offers antibiotics, neuro-muscular system products, and chemotherapeutics.

Founded in 1962, Shin Poong Pharm. Co., Ltd. has been implementing its own technology development and export diversification from raw active pharmaceutical ingredients to finished drugs since its inception and is a trusted partner of WHO.

The Phase II study (SP-PA-COV-201) was a placebo-controlled, randomized, double-blind trial that evaluated 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 either in a Pyramax treatment group or in a placebo control group. The study recruited 113 patients from 13 clinical sites in Korea, with an average age of 52 years, including 100 patients (88.5%) with mild COVID-19.

Clinical outcomes have reported a low-risk results from patients who underwent hospitalization, oxygen therapy, additional organ support, or worsening of symptoms leading to serious conditions or death. A 55.4% lower in the Pyramax-treated group 2/52 (3.8%) compared with the placebo group 5/58 (8.6%) were documented, although not statistically significant due to small sample size.

For infectious viral load, the analysis of the high-risk patient’s subgroup with at least one risk factor for severe illness (e.g., older age, obesity, or underlying diseases)1 showed complete viral clearance in the Pyramax-treated group at Day 10 (0/16), in contrast to the placebo group which showed incomplete clearance after 28 days (4/28 at Day 10, 2/28 at Day 28). While this did not 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 (P=0.0143) favoring the Pyramax-treated group (96.3% viral reduction in adjusted mean change from baseline) over placebo (34.5% reduction).

Recently, global needs for oral medication for outpatients have increased. If efficacy and safety for COVID-19 are confirmed in Phase III, 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.

When it comes to safety and side-effects, the percentage of patients with adverse events was 40.4% in the Pyramax-treated group compared with 48.3% in placebo-treated group, which was not statistically significant. The most common adverse events, apart from pneumonia due to the progression of the disease, included nausea (13.5%), dyspepsia (11.5%), headache and diarrhea.

Meanwhile, Pyramax has been approved under the brand name, Arpycom® and is currently recruiting patients for phase 2/3 clinical trials in 402 participants in the Philippines at PGH (Philippine General Hospital) and LCP (Lung Center of the Philippines).

Reference Link : The Safety and Efficacy of Pyronaridine-artesunate

(Pyramax® or Artecom® ) in COVID-19 Patients – Full Text View – ClinicalTrials.gov.

 
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