Korean pharmaceutical companies speed up clinical trials to develop Covid-19 treatments using drug repositioning, in keeping with the government’s schedule to introduce Covid-19 therapies by Jan 2021.
For instance, Daewoong Pharmaceutical and Chong Kun Dang are testing pancreatic drugs Foistar (ingredient: camostat mesylate) and Napabeltan (ingredient: nafamostat mesylate), respectively, to find their efficacy on treating Covid-19.
Drug repositioning is a method of developing new drugs by identifying new indications for already commercialized medicines or those in the clinical stage. Companies can quickly develop new drugs at a relatively lower cost using this method compared with existing new drug development strategies.
Daewoong Pharmaceutical and Chong Kun Dang are rival drugmakers. Their annual sales are similar, and there are many overlapping products such as high blood pressure and gastroesophageal reflux disease treatments.
Chong Kun Dang began the development ahead of Daewoong Pharmaceutical. In June, Chong Kun Dang received approval from the Ministry of Food and Drug Safety for its phase 2 clinical trial to develop a blood anticoagulant and acute pancreatitis drug, Napabeltan, as a Covid-19 treatment.
Daewoong immediately followed the example of its rival. The company won regulatory approval for a phase 2 clinical trial of its chronic pancreatitis therapy Foistar in treating Covid-19.
These two pharmaceutical companies also started clinical trials overseas.
Chong Kun Dang confirmed positive clinical results in the study of 50 Covid-19 patients given a placebo and Napabeltan for 10 days in Russia.
Russia’s Data Safety Monitoring Board (DSMB), which decides whether to continue the clinical trial according to the drug's safety and efficacy, recommended Chong Kun Dang to continue the study.
DSMB recommends whether to continue the clinical trials when about half of the targeted number of patients participate in the study.
"Chong Kun Dang plans to complete the clinical trial within 2020 based on the DSMB recommendation," an official of Chong Kun Dang said. "We are planning to apply for a conditional permit in Korea and discussing the schedule for review and approval related to clinical results with the Ministry of Food and Drug Safety."
Daewoong Pharmaceutical presented its study results of Foistar that confirmed its effectiveness in treating mild Covid-19 patients in Korea.
The company's process is considerably faster than many other drug candidates facing difficulties in recruiting patients. As soon as the complete clinical results are confirmed, Daewoong will begin applying for the emergency use approval.
Daewoong aims to commercialize the drug next January to make it the first Korean drug prescribed to mild Covid-19 patients.
The Korea Disease Control and Prevention Agency has proposed Daewoong conducts clinical trials of Foistar and Remdesivir to treat mild patients.
"Foistar tablet is the same drug as Tamiflu for Covid-19 in that it is safe and can be administered immediately." Daewoong Pharmaceutical CEO Jeon Seng-ho said. “We will be able to demonstrate the efficacy and safety of Foistar in the study."