Shinpoong Pharmaceutical said it was aggressively working on global trials of Pyramax (ingredient: pyronaridine/artesunate), an antimalarial drug, for Covid-19 treatment. The company began two studies this month alone.
Shinpoong obtained approval from the FDA Philippines to go ahead with the Phase-2/3 trial to develop the medicine as a Covid-19 treatment on Monday.
The study will test Pyramax’s efficacy and safety in 402 patients with mild, moderate, and severe Covid-19 symptoms. Six hospitals, including the state-designated clinical trial institution Philippine General Hospital, will conduct the trial.
The company will have a phase-2 trial in 20 patients first to evaluate the safety and efficacy depending on the disease's seriousness. Then, the company will randomly assign the drug to 382 patients.
Researchers around the world have expressed much interest in Shinpoong’s study.
Liverpool School of Tropical Medicine of the U.K. will start the phase-3 study of Pyramax for Covid-19 treatment on Friday. The study is scheduled to end on July 31, 2023.
According to the U.S. trial information site clinicaltrials.gov, the phase-3 study in Kenya and Burkina Faso will compare Pyramax with another first-line antimalarial drug Coartem (artemether/lumefantrine) in 142 patients who have contracted Covid-19 and malaria simultaneously.
The primary endpoint is the proportion of participants with a negative nasal swab on Day 7 after the start of treatment.
Bill and Melinda Gates Foundation is funding the trial, and collaborators include London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Groupe de Recherche Action en Sante (GRAS), Centres for Disease Control and Prevention, Kenya, and the U.S. Centers for Disease Control and Prevention (CDC).
The January issue of Trends in Parasitology published a report, saying Pyramax’s mechanism showed potential as Covid-19 treatment.
In the report, Professor Sanjeev Krishna at Centre for Diagnostics and Antimicrobial Resistance at the St George's University of London said it was too early to conclude that pyronaridine-artesunate had the effect of treating Covid-19, but laboratory research results were promising. “To shorten the Covid-19 treatment period and raise survival rate, we should carry out clinical trials quickly,” he said.
Shinpoong is also testing the drug in phase-2 trials in Korea and South Africa.
The company said the local trial was adding institutions, and the one in South Africa was also going smoothly. If the company finishes the Philippines' study, it can secure clinical results of over 600 patients, it said.
Shinpoong said it would seek emergency use approval in Korea.
“Shinpoong Pharmaceutical owns the global rights of Pyramax, which won approval as the nation’s 16th novel drug,” an official at Shinpoong said. “We will accelerate clinical trials to secure the results as soon as possible, and contribute to the global fight against the pandemic with an effective and safe treatment.”