Korean pharmaceutical and biotech companies have jumped in developing treatments against the new coronavirus. Still, no firm has entered a clinical trial stage so far due to insufficient data.
Some of the companies were so focused on promoting development plans that they did not even prepare minimal data necessary to conduct a study.
The Ministry of Food and Drug Safety has approved six clinical trials of drug candidates against COVID-19 as of Wednesday. Three of them are phase-3 studies of Gilead Sciences’ remdesivir, an antiviral medicine with the most potential.
The other three are for testing Kaletra (lopinavir+ritonavir), Oxiklorin/ Haloxin (hydroxychloroquine), and Alvesco (ciclesonide) in investigator-initiated trials.
The three medicines, except for remdesivir, have been already used in other diseases such as AIDS or malaria. Kaletra was used during the SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome) outbreak.
Antimalarial drugs such as hydroxychloroquine showed effect against COVID-19.
Alvesco’s efficacy against COVID-19 was first reported in Japan, and Institute Pasteur Korea obtained the nod for the clinical trial plan based on a drug repositioning study.
Gilead had been developing remdesivir as a treatment for Ebola but proved its efficacy against COVID-19 by testing it on animals infected with the MERS and SARS virus.
Pharmaceutical companies around the world are conducting trials on COVID-19 treatment candidates using these agents.
Phase-3 studies of autoimmune disease treatments, including Actemra (tocilizumab), Kevzara (sarilumab), Olumiant (baricitinib), and Zacavi (ruxolitinib), are also in progress.
Antiviral agents such as Arbidol (umifenovir), Avigan (favipiravir), and Tamiflu (oseltamivir) are also in trials.
Korean companies also acted quickly to develop COVID-19 treatments.
However, there is no clinical trial conducted by a Korean company for a COVID-19 treatment among about 100 clinical trials worldwide registered at ClinicalTrials.gov.
Only three firms -- Komipharm International, Bukwang Pharmaceutical, and CrystalGenomics – have submitted the Investigational New Drug (IND) application for COVID-19 treatment to the Ministry of Food and Drug Safety.
Komipharm filed for clinical trial approval for new drug candidate Panaphix to treat COVID-19 in late February but has failed to obtain the nod after failing to submit supplementary data.
ImmuneMed recently requested the regulatory grant for hzVSF, initially a treatment for inflammatory viral diseases, to be used for multiple COVID-19 patients in clinical trials. However, the regulator asked the firm to provide complementary data that includes the result of testing the drug against the COVID-19 virus in cells.
Kangstem Biotech announced on March 20 that Yeungnam University has applied for approval for the use of its stem cell therapy FureStem RA. Still, the government has not granted the nod for more than two weeks. The food and drug safety said it would take only a few days to approve a drug for COVID-19 treatment.
Despite insufficient clinical data, many firms were promoting their development plans with phrases such as “fast clinical trials,” “trial application,” and “anticipated efficacy.”
Such expressions were misleading as if they were entering clinical trials soon, observers said.
Listed biotech firms, including Komipharm, GC LabCell, Celltrion Pharm, Kangstem Biotech, and Sillajen, saw their stock prices skyrocketing on the news of the start of COVID-19 drug development alone.
Some observers raised concerns about the biotech industry’s exaggerating progress of development of a treatment or a vaccine, just like they did in the MERS outbreak in 2015.
At the time, Ilyang Pharmaceutical, Celltrion, and GC Pharma raced to work on treatment or a vaccine against the MERS virus but only GeneOne Life Science could enter clinical trials.
<© Korea Biomedical Review, All rights reserved.>