Shinpoong Pharmaceutical said it registered the first patient for the domestic phase 3 trial of Pyramax (pyronaridine/artesunate), an oral drug for Covid-19 treatment.
“At around 7 p.m. on Monday, we enrolled the first Korean patient for the phase 3 study at Sahmyook Medical Center,” an official at Shinpoong told Korea Biomedical Review.
The phase 3 study evaluates Pyramax’s efficacy and safety in 1,420 patients with mild or moderate Covid-19 infection. The trial will be multi-center, randomized, double-blind, and placebo-controlled.
The primary endpoint will be the proportion of hospitalized or dead participants who required oxygen treatment or more medical intervention due to Covid-19 infection until day 29.
Mild Covid-19 patients isolated at community treatment centers and high-risk hospitalized patients who do not require oxygen treatment will receive the drug candidate. Vaccinated people can also participate in the trial.
Other major outcome measures include time to clinical improvement, clinical indicators such as the WHO Ordinal Scale of clinical status, pneumonia incidence, and changes in viral loads.
Pyramax is a combination drug of pyronaridine and artesunate, inhibiting the entry and assembly of the Corona 19 virus into cells and viral proliferation. The drug also activates the type 1 interferon pathway to improve virus-induced inflammation and lung lesions.
The drug can be taken orally once daily for three days.
Pyramax obtained the permit as a malaria treatment in 2012 and proved safety in more than 2 million pediatric and adult malaria patients worldwide.
Its mechanism will not be much affected by Covid-19 variants and treat patients, Shinpoong said.
If Shinpoong confirms the efficacy and safety of Pyramax in the phase 3 trial, the drug will be the first homegrown oral Covid-19 treatment.
As the drug is already authorized as an anti-malaria treatment, Shinpoong will be able to supply the drug swiftly around the world.
Shinpoong confirmed the safety of Pyramax in 113 mild or moderate Covid-19 patients in the previous phase 2 study. In addition, the investigational drug showed a significant antiviral effect in the group with high infectious viral loads and a tendency to lower the chance of progressing towards critical Covid-19, the company said.
To seek marketing approval in other countries, the company is already conducting a trial in the Philippines and plans to test the drug in Europe and South America.
“Due to the spread of the virus variants despite the supply of vaccines, some countries are responding to Covid-19 as an infectious disease that does not disappear, like influenza,” Shinpoong said. “We hope the oral drug can prevent progress to serious Covid-19 and viral transmission in early-stage infection and become an additional, convenient treatment option for mild, moderate patients, and a new treatment option for outpatients such as those in home-isolation.”
An early drug administration within three to five days after the appearance of symptoms in mild and moderate Covid-19 cases is quite difficult under the current quarantine rules. Still, the company hoped to do so in higher proportions of patients in the phase 3 trial, it added.