|A lab technician at Celltrion tests drug candidates in this file undated file photo released by the company. Courtesy of Celltrion|
Securing patients for clinical test proves difficult
By Nam Hyun-woo
Korean pharmaceuticals and biotechnology firms are rushing to develop COVID-19 treatments in a bid to take the lead in the market.
With Gilead Sciences' Remdesivir gaining global attention with its fast development, Korean drug makers are also making strides in the development process, but facing a setback in securing patients for clinical studies due to the country's fast recovery from the pandemic, industry officials said Thursday.
According to the Ministry of Food and Drug Safety (MFDS), it has approved a phase two clinical trial of Bukwang Pharmaceutical's Levovir antiviral drug for treating COVID-19 patients last month.
Following this, Bukwang will announce the outcome in August, meaning Levovir will likely be the fastest COVID-19 treatment available in the domestic market.
Bukwang's Levovir was launched in the domestic market in 2007 as a treatment for hepatitis B. The company said in March that Levovir "showed comparable antiviral effects to Kaletra, which is currently being used for treating COVID-19" and it has filed a patent application on it.
In developing a new drug for COVID-19, Genexine, Celltrion and GC Pharma are vying for the pole position.
Celltrion, which is developing antibody drugs stemming from cured COVID-19 patients' blood sample, said last month it confirmed neutralization effect of its candidate monoclonal antibodies and selected 38 potent antibodies for its treatment.
Based on this, the company will launch clinical tests in mid-July, and it will test whether the treatment can be used as a coronavirus vaccine.
Smaller biotech firm Genexine is also making fast progress in COVID-19 treatment development. The company said Wednesday it has confirmed antibodies neutralizing the coronavirus in monkeys applied with its DNA vaccine GX-19.
Genexine CEO Sung Young-chul said the company expects to proceed with a clinical trial in June if the domestic health authorities grant approvals promptly.
GC Pharma, which is also developing blood plasma COVID-19 treatments for serious cases, is seeking to launch a clinical trial in July.
Despite their effort to develop COVID-19 treatment, securing patients for clinical trials is presenting a huge obstacle because of Korea's quick recovery from the COVID-19 impact.
According to the Korea Clinical Trials Information Center, there are nine clinical trial applications filed to the MFDS as of April 27. This includes two studies by Gilead Sciences Korea on Remdesivir, Bukwang's Levovir and six projects carried out by university hospitals across the country.
The number of patients they are seeking to observe in the clinical study is 3,256. Given Korea has 1,135 people who are under treatment or being quarantined as of May 7, industry officials said it is certain that there will be a shortage of patients for clinical studies even though drug makers have made strides in their development.
"Though the number of patients companies are seeking to enroll in their clinical trials will be different between the types of treatments, it is undeniable that there are concerns over securing enough patients for trials," said an official at a firm developing COVID-19 treatments. "It is good to see the number of patients decline in Korea, but the importance of securing patients will increase in the near future given the advantage of early market entry."
Another COVID-19 treatment developing firm official also said the demand for COVID-19 treatment will continue due to the possibility of the COVID-19 pandemic being protracted, but not many drug makers are capable of running global clinical trials. Thus, the priority in securing patients should be coordinated by the government.
The government said on April 24 that it will come up with a standard in setting the priority in securing patients for clinical trials, due to the limit in the number of available patients.
Patient shortage is not just an issue for companies in Korea.
Last month, Gilead Sciences ended two of its Remdisivir trials in China, saying "the epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruited."