Shinpoong Pharmaceutical, already working on multinational phase 3 trials of antimalarial treatment Pyramax in Covid-19 patients, said it would begin a new phase 2 study in Korea.

The company said that the new study aims to confirm Pyramax’s effect against the Omicron variant.

Shinpoong Pharmaceutical said it would begin a new local phase 2 study of Pyramax to check its effect against the Omicron variant.
Shinpoong Pharmaceutical said it would begin a new local phase 2 study of Pyramax to check its effect against the Omicron variant.

On Monday, the Ministry of Food and Drug Safety granted a nod to Shinpoong’s plan to test Pyramax (artesunate/pyronaridine) in a phase 2 study in Korea.

The phase 2 trial will explore the efficacy and safety of Pyramax to treat mild or moderate Covid-19. It will be a multi-center, single-group, open, and exploratory study.

The clinical site will be Inje University Ilsan Paik Hospital.

Shinpoong is conducting phase 3 trials in multiple countries, including Korea, to repurpose Pyramax as a Covid-19 treatment.

The phase 3 trials obtained approval in Korea, the U.K., Argentina, and Chile. The company is waiting for a nod for the trial in Poland and Colombia.

The phase 2 study in Korea will be run separately from phase 3 trials, Shinpoong said.

“The phase 2 trial in Korea aims to confirm the efficacy of Pyramax against the Omicron variant,” an official at Shinpoong said. “The study will be only exploratory, and there is no more detail to disclose about a change in (Pyramax) development strategy.”

The official went on to say that the ongoing phase 3 trials were progressing smoothly.

Shinpoong is enrolling patients and administering the experimental drug in countries where the phase 3 trials obtained approval.

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