UPDATED WITH QUOTES FROM COMPANY
South Korean pharmaceutical company Celltrion has won permission for phase one clinical trials of a potential Covid-19 treatment in the United Kingdom.
Celltrion’s CT-P59, an anti-viral antibody treatment, had the green light for the trial in patients with mild Covid-19 from the UK medicines regulator on Thursday, the company said.
Celltrion, which plans to start commercial production in September, is hardly alone. At least 157 vaccines and 337 therapeutic drugs are under urgent development globally.
On July 17, the company got the go-ahead for phase one trials in South Korea on 32 subjects. These trials are expected to be complete by the third quarter, Korean media reported. South Korean health officials say Seoul is preparing generous subsidies for locally made anti-Covid-19 drugs and vaccines.
However, as Covid-19 clusters pop up in nations which thought they had largely contained the pandemic, officials in South Korean and Germany warn that no vaccine is likely to be rolled out this year.
In pre-clinical data, CT-P59 demonstrated a 100-fold reduction in the viral load of SARS-CoV-2, as well as a reduction in lung inflammation, Celltrion said.
“Antibody treatment has fewer side effects than other forms of treatment,” Lee Eun-young, a Celltrion official, told Asia Times. “The antibody treatment we are developing will only target Covid-19, so we believe it will be more efficient in tackling the epidemic.”
Moreover, “antibody treatments can deal better with viral mutations than antiviral treatments,” Lee said.
Celltrion plans to conduct global phase two and three trials in patients with mild and moderate Covid-19, and anticipates results by the end of the year.
Separate trials investigating CT-P59’s use as a preventative measure, which will enroll people in close contact with Covid-19 patients globally, are also planned. Data from the latter trials are anticipated in the first quarter of 2021.
The company, which started life in 1999 and is based in the futuristic new town of Songdo, near Incheon International Airport, obtained global distribution for its products in 2008. While its early products were biosimilars – ie generics – CT-P59 is an original product, based on Celltrion’s prior experience with antibody treatments for influenza and MERS, Lee said.
Celltrion appears confident that the trials will be successful. It said it will begin full-scale commercial production of its treatment in September and plans to secure enough capacity to produce five million doses by the end of the year.
Scale and economy
“We are making efforts to ensure that if the clinical trial program is successful, we are able to scale up manufacturing appropriately,” senior executive vice-president Dr Sang-joon Lee said.
Separately, Celltrion Group chairman Seo Jung-jin said in a YouTube press conference last week, that he would ensure the affordability of the treatment.
“To end the pandemic, each of more than 7 billion people across the world has to be supplied with coronavirus treatments and vaccines,” he said.
“That is, however, an unrealistic idea because the prices of drugs are too expensive. Only OECD member countries will be able to supply enough treatments and vaccines to their people.”
Though Seo did not mention it by name, Gilead Science’s drug Remdesivir has faced criticism for its $390 per-vial price.
Celltrion plans to spend 300 billion won ($250 million) on anti-Covid treatment and development, Seo said, and will cut costs by lowering manufacturing costs and profits.
The race is on
Lee, Seo and Celltrion may soon find themselves in a crowded playing field. An intense global race is underway as companies and research institutes vie to be first with a vaccine and/or a treatment.
Still, given the unprecedented scale of the crisis, there is plenty of room for multiple players. “We believe that many more companies do need to partake in developing vaccines and treatment for Covid-19 in order to meet the medical demands of millions of patients from all over the world,” said Lee, the company official.
Online science site Biorender says 157 vaccines are under development, with 35 undergoing human trials. Moreover, 337 therapeutic drugs are being developed, 259 of which are undergoing human trials.
In a document updated on July 31, the World Health Organization detailed 26 vaccine candidates in various stages of development worldwide.
Research institutions engaged in the work range from the UK’s Oxford University to Osaka University to the Chinese People’s Liberation Army Academy of Military Sciences. Companies run the gamut from AstraZeneca to Pfizer to Sinpharm.
One of the most high-profile potential vaccines, ChAdOx1-S, developed by Oxford University and AstraZeneca, is in phase three clinical trials in Brazil. The tests started on May 20, but are not expected to conclude until July 2021.
However, the WHO list is not complete. Celltrion’s product – which has not entered trials yet – is not on it. Nor is the product that just may win the global race, a Russian vaccine jointly developed by the state-run Gamaleya National Research Centre for Epidemiology and Microbiology and the Main Military Clinical Burdenko Hospital.
Russia’s sovereign wealth fund head Kirill Dmitriev, who funded the research, told media on July 16 that the vaccine would be ready for mass production by the end of August, and 200 million doses would be available by year-end. It is set to begin stage three clinical trials in Russia and the Middle East from August 3.
Even so, Russian experts told Asia Times that the research methodologies used – the first and second stage clinical trials were conducted on Russian soldiers, and the whole project has been undertaken with unusual speed – might make other countries wary of the product.
In Celltrion’s home base, South Korea – authorities are dialing back expectations of a speedy vaccine rollout. Senior health officials said on July 17 they did not expect any vaccine program this year.
South Korea is not the only country prioritizing prudence over speed. Earlier this week, Germany’s research minister said it would be unlikely for any vaccine to be ready until mid-2021 at the earliest.