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Phase II COVID-19 study in Korea for Pyramax topline results revealed

Shin Poong Pharm. Co., Ltd. has announced the topline safety and efficacy results of the recently completed Phase II study in Korea of Pyramax or Arpycom (a fixed dose combination of pyronaridine tetraphosphate and artesunate) for COVID-19.

Phase II COVID-19 study in Korea for Pyramax topline results revealed

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.

Viral load reduction

The primary endpoint, as measured by the proportion of patients with virological clearance for SARS-CoV-2 based on reverse transcription polymerase chain reaction (RT-PCR) diagnostic testing, was not met. However, recent publications have challenged validity of the cutoff values measured with RT-PCR diagnosis to determine a virus negative status.

For infectious viral load, the analysis of the high-risk patients 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 2.8fold 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).

Lower risk based on who ordinal scale and national early warning score (NEWS)

With regard to clinical outcomes, the proportion of patients who underwent hospitalization, oxygen therapy, additional organ support, or worsening of symptoms leading to serious conditions or death (i.e., patients with 3 or higher WHO ordinal scale)[2] was 55.4% lower in the Pyramax-treated group 2/52 (3.8%) compared with the placebo group 5/58 (8.6%), although not statistically significant due to small sample size.

A more pronounced trend for improvement was seen for the high-risk patient group where the proportion of patients with severe clinical outcomes was 74.3% lower in patients treated with Pyramax 1/28 (3.6%) vs. those in the placebotreated group 5/36 (13.9%).

In addition, according to the National Early Warning Score (NEWS)3, which is 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% lower in the in the Pyramax-treated group in overall population [13.5% of Pyramax-treated patients (7/52) compared with 20.7% of placebo-treated patients (12/58)] and in patients with high-risk [14.3% of Pyramax-treated patients (4/28) compared with 22.2% of placebo-treated patients (8/36)], respectively.

In the full analysis set, there were no deaths in the Pyramax-treated group, while there was one death in the placebo-treated group (1.7%). Four patients (7.7%) in the Pyramax-treated group and 7 patients (12.1%) in the placebotreated group experienced aggravation of symptoms due to pneumonia.

Safety examined

Regarding the safety of Pyramax in the treatment of COVID-19, 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. There were no SUSARs (Suspected Unexpected Serious Adverse Reactions), suggesting that Pyramax is well-tolerated in COVID-19 patients.

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,” the official added.

This Phase II 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. 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.

Phase II COVID-19 study in Korea for Pyramax topline results revealed

Philippine Clinical Trials

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).

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 company currently has global presence in 5 countries with 3 manufacturing plants located in Vietnam, Sudan, and China.

Phil Shinpoong Pharma Inc. was established in 2002 and has launched over 50 products in the Philippine market. 

Topics: Shin Poong Pharm. Co. Ltd. , Phase II study , COVID-19
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