Local drug companies are making an all-out effort to increase sites for clinical trials on potential Covid-19 treatments, as the declining new confirmed cases of Covid-19 might frustrate patient recruitment.
As of midnight Thursday, Korea had 11,122 confirmed cases of Covid-19 and 10,135 of them were cured, according to the Korea Centers for Disease Control and Prevention (KCDC). The other 987 Covid-19 patients are under treatment.
Daily numbers of new patients have recently remained below 20. Although the number once exceeded 30 due to the spread of infections from night clubs in Itaewon, it quickly came down below 20. From May 1 to May 21, Korea had an average of 17 daily new cases.
The flattening curve is a positive sign, but treatment developers face an irony that a dropping number of patients means less chance to recruit patients. Delayed patient recruitment prolongs clinical tests and treatment development.
The speed of developing treatment is crucial in a pandemic situation. A delayed study could hurt a drugmaker’s commitment to a new drug.
When the Ebola outbreak threatened the world, pharmaceutical firms around the globe rushed to develop a treatment, but many of them dropped the research after the outbreak. During the Middle East Respiratory Syndrome outbreak in 2015, many domestic companies embarked on treatment research, but none of them entered a clinical trial. Even now, no company has a license for a MERS drug.
Drugmakers might experience the same problem during the current Covid-19 pandemic, observers said.
Bukwang Pharmaceutical, Shinpoong Pharmaceutical, and Enzychem Lifesciences are conducting trials of Covid-19 treatments in Korea. Bukwang is testing its hepatitis B treatment Levovir (clevudine) in a phase-2 trial, Shinpoong, antimalarial agent Pyramax, and a phase-2 study. Enzychem is soon to start a phase-2 study on EC-18, a treatment candidate for Covid-19.
As Gilead is still recruiting patients to test remdesivir, and many other investigator-initiated studies are ongoing, the latecomer three firms will find it challenging to recruit patients.
On the positive side, however, the three companies will test the potential drugs on patients with mild or moderate symptoms, not seriously-ill patients.
Bukwang is recruiting 60 patients with moderate symptoms, and Shinpoong, 116 with mild or moderate symptoms. Enzychem aims to gather 60 patients with infectious pneumonia caused by Covid-19.
About 80 percent of local Covid-19 patients have mild symptoms. Although the number of patients with moderate symptoms is smaller than those with mild ones, the number is larger than that of severe patients. This will help Shinpoong and Bukwang proceed with the trial plan as scheduled, observers said. Patients with infectious pneumonia are believed to account for 20 to 30 percent of the total Covid-19 patients.
The three local companies are trying to increase clinical sites as many as possible to brace for a fierce competition to recruit patients amid rising Covid-19 treatment tests.
“We recently signed a memorandum of understanding with North Chungcheong Province and Chungbuk National University Hospital to raise the participation of the Covid-19 patients in the region,” an official at Enzychem said.
With a recent rise of Covid-19 patients in Seoul and Gyeonggi Province, the company is trying to expand clinical sites in the region, too, he added. Enzychem aims to have up to 9 clinical sites in Seoul and Gyeonggi Province.
Bukwang has already built eight clinical sites and plans to complete the trials in August. “We are recruiting patients with moderate symptoms, not critically ill patients. So, our patient recruitment is on schedule,” an official at Bukwang said. “Even if the recruitment gets delayed, we are discussing with the regulatory authorities to have an alternative.”