ImmuneMed, a local biotech firm, has come under criticism for exaggerating the effect of an investigational antiviral drug against the new coronavirus (COVID-19).
The company had claimed that a COVID-19 patient treated with its experimental drug, hzVSF (humanized virus suppressing factor), fully recovered from the disease. However, the cured patient is known to have received the combination therapy of hzVSF and remdesivir, known to be most effective against COVID-19.
Critics said ImmuneMed could not even prove the agent’s efficacy in a cell test and that the company blamed the regulator for not approving additional trial.
Industry sources said on Friday that ImmuneMed recently requested the Ministry of Food and Drug Safety to grant the nod for hzVSF, initially a treatment for inflammatory viral diseases, to be used for multiple COVID-19 patients in clinical trials.
The ministry asked the company to submit complementary data, but the company said it would develop the drug in a foreign country where trial requirements are less demanding.
ImmuneMed CEO Kim Yoon-won said in a local media interview on Wednesday that two severe COVID-19 patients treated with the company’s investigational drug wholly recovered at the Seoul National University Hospital.
“The patients’ conditions were so serious that they had to be moved to the intensive care unit. After getting hzVSF, their viral activities within the body were suppressed, and their acute pneumonia disappeared,” Kim said during the interview, emphasizing the agent’s efficacy.
ImmuneMed has obtained the temporary green light for hzVSF to be used for six COVID-19 patients at SNUH, Yeungnam University Hospital in Daegu, and Chungnam National University Hospital.
The approval was given on the condition that the individual COVID-19 patients could receive the treatment at the discretion of the attending doctor. The company took a step further to seek the license to use the drug for up to 24 patients simultaneously.
To acquire the nod for drug use for many people, the company has to submit additional data to prove that the investigational agent is effective against the disease. However, ImmuneMed did not provide complementary data that includes the result of testing the drug against the COVID-19 virus in cells.
“For the company to get approval for therapeutic purposes for more than two people, it needs to submit data on a cell test against COVID-19. But the company did not, so we requested the needed data,” an official at the food and drug safety ministry said. “Since we didn’t reject the request, we can grant the nod as long as the company submits complementary data.”
In response, ImmuneMed said the company could not earn sufficient results from a cell experiment.
“Suppressing viral activities takes place not in a particular cell but within the body because the drug becomes effective through intercellular exchanges,” the company’s CEO Kim said in the interview with Maeil Business Newspaper.
Injecting its drug to COVID-19 patients helped them recover completely, and the company would keep developing the drug overseas, he added.
However, Kim did not mention in the interview article that the cured patients did not receive hzVSF as monotherapy but a combo therapy of hzVSF and remdesivir, an investigational drug being developed by Gilead for the treatment of COVID-19.
Remdesivir showed the most promising effect in cell experiments among eight experimental drugs for COVID-19, including Chloroquine and Kaletra, in an interim analysis on COVID-19-related treatments released by the Korea Research Institute of Chemical Technology on Thursday.
Clinical researchers pointed out that if a drug does not work in a cell test, it would be difficult to become a COVID-19 treatment. Even if an agent shows excellent efficacy in a cell test, the clinical effect could fall short of the lab result, they noted.
“ImmuneMed’s treatment is a substance suppressing various viral activities rather than working against COVID-19 alone. I don’t expect much for the drug because it does not attack the virus directly,” said Kim Shin-woo, leader of the Infectious Disease Management Support Task Force of Daegu Metropolitan City. “The company seems to be hopeful because one person got cured. But in many cases, people recover naturally, too.”
ImmuneMed’s claim – that the regulator granted the nod for individual six COVID-19 patients because it recognized the agent’s effect – was not true.
Seeking approval for therapeutic purposes for individual patients requires only a specialist’s opinion and a medical certificate. The company does not have to submit data on the drug’s efficacy.
“The company said it would seek clinical trials overseas because the local regulations were tough. But I don’t think any other country would have easier regulations than Korea. The company will have to exclude the U.S. or Europe, too,” an official at the food and drug safety ministry said.
ImmuneMed refused to comment on the points made by the ministry official.