The world needs Covid-19 treatments now more than ever due to the continuing increase of Covid-19 cases, but it will take a considerable time to commercialize Korea’s second Covid-19 treatment, industry watchers said.
Among locally developed Covid-19 treatments, Celltrion’s Regkirona (ingredient: regdanvimab) is the only drug that obtained the regulatory nod. In February, the Ministry of Food and Drug Safety granted conditional approval for Regkirona to treat Covid-19 patients with mild to moderate symptoms in high-risk groups.
On Aug. 12, Celltrion sought changes in approval conditions for Regkirona based on global phase 3 trial results to obtain full approval.
In Australia, Celltrion’s partner Inhalon Biopharma is conducting a phase 1 trial of an inhaled version of Regkirona.
In Korea, 15 drugmakers, including Celltrion, are developing Covid-19 treatments. The rest are Chong Kun Dang, Daewoong Pharmaceutical, Shinpoong Pharm, Bukwang Pharmaceutical, Korea United Pharm, NewGen Therapeutics, ImmuneMed, Genexine, GC Wellbeing, Shaperon, Dongwha Pharm, CrystalGenomics, Enzychem Lifesciences, and Telcon RF Pharmaceutical.
Except for Shaperon that conducted a study in Europe only, 14 companies received approval for local trials. Chong Kun Dang, Daewoong Pharmaceutical, ImmuneMed, Genexine, and Celltrion are working on overseas studies, too, to make patient recruitment easier, diversify dosage forms, and respond to Covid-19 variants.
Chong Kun Dang, Daewoong enter phase 3 trials
Chong Kun Dang and Daewoong Pharmaceutical are the only two companies that have entered phase 3 trials, the last stage before getting the marketing permit.
In March, the MFDS refused to give a conditional nod for Chong Kun Dang’s treatment candidate, CKD-314 (nafamostat mesylate). However, the company received the green light for global phase 3 trials, including Korea, in April and is recruiting patients. The company expected that it would take some time to complete patient enrollment.
Daewoong is developing DWJ1248 (camostat mesylate). In addition, the company received approval for a local phase 3 study for Covid-19 prevention and another trial to treat serious Covid-19, respectively.
Now, however, the company is focusing on phase 2b trial results to treat Covid-19 patients with mild and moderate symptoms.
In July, Daewoong released the topline results of the phase 2b study, which failed to meet the primary endpoint of shortening the period of clinical symptom improvement.
Thus, the company will derive the entire trial outcome, consult with the government, and decide whether to seek conditional approval and a later-stage study, according to Daewoong.
Shinpoong, Bukwang failed to meet primary endpoint in phase 2 trials
Shinpoong Pharm and Bukwang Pharmaceutical have completed phase 2 studies. Still, both failed to meet the primary endpoint of the virus-negative conversion or the proportion of Covid-19 patients who turned negative from positive in RT-PCR tests.
Last month, Shinpoong said the topline results of the phase 2 study showed that there was no statistical difference between Pyramax and placebo groups.
Still, the company said it found “evidence for the antiviral effect and the potential for improving overall clinical indicators” and would continue a follow-up study.
Shinpoong said it would submit a follow-up clinical trial plan to the MFDS by July, but the approval has not been confirmed so far.
Bukwang Pharmaceutical, which suffered a setback in a phase 2 trial of Levovir (clevudine), derives the overall results of the phase 2-2 trial with a changed protocol.
The company did not provide any timeline for the release of the final results.
“It has become a global trend to check the viral load reduction, instead of the virus-negative conversion, in Covid-19 treatment,” an official at Bukwang said. “We expect that Levovir will play its role as an oral drug with better patient convenience.”
Enzychem Lifesciences, working on a natural drug candidate EC-18, completed drug administration in a phase 2 study in February.
However, the company has yet to announce the results.
Korea United conducts phase 2 study of inhaled drug
Many other local companies have entered phase 2 trials, but some did not even start enrolling patients.
In May, Korea United Pharm was the only Korean company to receive approval for an inhaled Covid-19 treatment trial. The company did not comment on the detailed progress of the study but said the trial was going smoothly.
“We aim to end the drug administration in the phase 2 study within this year,” an official at Korea United Pharm said.
GC Wellbeing and Dongwha Pharm have yet to enroll patients for trials of Laennec, a human placenta hydrolyzate injection, and a natural drug candidate DW2008S, respectively, because they could not select clinical trial institutions.
However, the two companies said that they did not give up on the studies and would begin patient recruitment soon.
CrystalGenomics, repurposing GC-CAM20 (camostat mesylate), decided to conduct the trial at the Asan Medical Center, but not even a single patient enrolled for the study.
“We have trouble recruiting patients in Korea due to the shortage of patients. So, instead of developing a Covid-19 treatment through drug repurposing, we are doing a toxicity test on a new therapeutic drug in the U.S.,” an official at CrystalGenomics said.
NewGen Therapeutics has completed the phase 1 study but did not plan for a phase 2 study. Instead, the company is reportedly searching for a partner firm to enter a later-stage trial.
Last month, Telcon RF Pharmaceutical received the nod for a phase 1 trial of lenzilumab, joining the list of Covid-19 treatment developers in Korea.
Humanigen, a Nasdaq-listed firm, developed Lenzilumab and Telcon RF, will proceed with the local trial as a Korean partner.
ImmuneMed, Genexine speed up trials overseas
ImmuneMed and Genexine are expediting Covid-19 treatment development in other countries than Korea.
ImmuneMed, which obtained approval for a local phase 2 study in December, is still recruiting patients. However, its overseas trials are ongoing actively, the company said.
The company plans to release the results of phase 2 trials conducted in Indonesia, Italy, and Russia in the fourth quarter.
Genexine, the only Korean developer of both Covid-19 vaccine and treatment, focuses more on overseas trials. The company obtained the nod for a local phase 1b study in August last year but started recruiting patients in May.
In contrast, the company has already started administering a Covid-19 drug candidate in a phase 2 trial in Indonesia after licensing GX-I7 to KG Bio, an Indonesian pharmaceutical company.
Genexine might change the protocol of the GX-I7 study to exclude mild Covid-19 patients and evaluate the therapeutic effect on moderate to serious Covid-19 patients, an official at Genexine said.
Shaperon disclosed the topline results of a phase 2 study conducted in Romania last month.
The company said its treatment candidate improved symptoms but did not say whether to apply for emergency use approval or to proceed with a follow-up trial.