Two Korean pharmaceutical companies are having difficulties in conducting Covid-19 treatment trials in the Philippines, industry officials said.

Korean drug developers had picked the Philippines as the optimal country to test Covid-19 drug candidates because it had many Covid-19 cases. However, along with the rising vaccination rate in the Philippines, the companies struggle to recruit local patients.

Shinpoong Pharmaceutical, working on an oral Covid-19 treatment Pyramax (pyronaridine and artesunate), added institutions for the phase 2/3 trials in the Philippines due to the difficulty enrolling patients.
Shinpoong Pharmaceutical, working on an oral Covid-19 treatment Pyramax (pyronaridine and artesunate), added institutions for the phase 2/3 trials in the Philippines due to the difficulty enrolling patients.

Daewoong Pharmaceutical recently decided to stop the phase 1 study of DWRX2003 (niclosamide), a potential Covid-19 drug, in the Philippines. According to Clinicaltrials.gov, a U.S. site for clinical trials information, Daewoong updated the status of the phase 1 trial as “terminated” on Sept. 16, one year after obtaining approval for the study in the Philippines.

Daewoong said that “enrollment was suspended since Dec. 9, 2020, due to a lack of Covid-19 patients.” As a result, the company could recruit only two Filipino Covid-19 patients.

Daewoong won the nod for the phase 1 trial of DWRX2003 from the FDA of the Philippines in September 2020. The company even advanced the regulator’s review process from four to two months through collaboration with a local firm, raising the prospect for the Covid-19 drug trial.

Daewoong had planned to divide 40 Covid-19 patients into five cohorts to test DWRX2003’s initial indicators of the drug’s effectiveness, including safety, tolerability, and efficacy.

However, the company gave up the trial eventually.

“With growing vaccination, it was difficult to recruit local patients in the Philippines. Most Filipinos do not see a doctor even if they get infected with Covid-19,” an official at Daewoong said.

Daewoong is conducting trials in various countries, in addition to the Philippines, considering race and environment, he added.

The company has completed the phase 1 study of DWRX2003 in India and Australia, respectively. Regarding Coviblock (camostat mesylate), another investigational Covid-19 treatment, the company will review whether to conduct a phase 3 trial after completing the domestic phase 2b study.

Industry watchers expect that Daewoong will announce the decision later this month at the earliest.

Shinpoong Pharmaceutical, working on an oral Covid-19 treatment Pyramax (pyronaridine and artesunate), added institutions for the phase 2/3 trials in the Philippines due to the difficulty enrolling patients. Shinpoong aims to recruit 402 patients for the phase 2/3 trials.

On Sept. 30, Shinpoong updated the status of the Phase 2/3 trials in the Philippines from “not yet recruiting” to “recruiting” and added three clinical sites, including De La Salle University Medical Center, according to Clinicaltrials.gov.

Shinpoong won approval for the phase 2/3 trials in the Philippines in January and started recruiting patients in March.

“The patient enrollment is not going smoothly,” an official at Shinpoong said. “We cannot predict the exact time of the completion of the study, but we will do our best to proceed with it as quickly as possible.”

Shinpoong is testing Pyramax in a phase 3 study in Korea, too. The company enrolled the first patient on Monday.

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