HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results.
“The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Sang Joon Lee, Celltrion’s senior executive vice president.
CT-P59 aims to neutralize the virulent D614G variant, associated with increased viral transmission and wide spread of the COVID-19 virus.
“We will carry out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year,” Lee said.
The phase I trial will see the company partner with Chungnam National University Hospital to test the treatment’s safety in 32 healthy volunteers who have not been diagnosed with the virus, and the company hopes to complete the trials by the third quarter of 2020.
“Animal tests have proved the efficacy of using antiviral antibody treatments, including CT-P59,” said Celltrion CEO Jung-Jin Seo in an online press conference. “Companies will now be focusing on bringing down the expensive costs of bringing to market an effective treatment with the fewest side effects possible at the best price.”
The company is also looking to conduct further phase I trials in several European countries, including the U.K., for patients with mild COVID-19. Preliminary results are expected by the end of 2020, with the company planning phase II/III trials in patients with mild and moderate COVID-19 on the back of the results from phase I.
Seo said that the company is also “carefully examining” the possibility of trials in Brazil, although he added that Celltrion has not yet initiated discussions with the Brazilian government and did not specify when the company would do so. There were more than 14.5 million COVID-19 cases and more than 600,000 deaths globally as of July 20, according to Johns Hopkins data. Brazil accounts for more than 2 million cases, second only to the U.S.
A third, global clinical trial to investigate the treatment as a preventive measure for volunteers in close contact with COVID-19 patients is also planned. The company hopes to have top-line data from that trial by the first quarter of 2021.
Celltrion Healthcare shares rose to ₩108,300 (US$89.8805) as markets opened on July 20, but closed at ₩104,600 on the same day. The company listed on the KOSDAQ board in June 2017, raising ₩1 trillion (US$829.922 million).
The company said that it reached the halfway point in the treatment’s development process in late March, constructing a 300-antibody library from blood samples collected from recovered patients.
Celltrion won approval from the Korea Centers for Disease Control and Prevention (KCDC) on March 18, after submitting an application to the KCDC’s emergency search for a COVID-19 cure, implemented after the country experienced a surge of cases. Seo had taken an interest even before the KCDC search was announced, and Celltrion, as a company in the biological and chemical fields, could not help but join in the effort.
There are six other companies – four American and two British – currently developing antiviral antibody treatments, according to Seo. One of the American companies, Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc., is the only other company to develop a treatment in-house, and it started human trials mid-June.
Celltrion is currently in the process of applying for FDA approval for three test kits under development to further the fight against COVID-19. It will launch a rapid antibody diagnostic testing kit, developed in partnership with in vitro diagnostics developer Humasis, in July, with an application for Europe’s CE certification to be submitted the same month.
Another joint production with Humasis, on a rapid antigen diagnostic kit, is scheduled to be launched in September. Celltrion completed its point-of-care antigen test kit, developed with health care startup BBB Inc., in June. The kit will be launched in August. Celltrion will apply for CE certification for the former in August and submitted the application for the latter in June.
Meanwhile, Celltrion’s Singapore arm inked an agreement on June 11 with Takeda Pharmaceutical Co. Ltd. Inc to acquire a primary care portfolio of 12 prescription and six over-the-counter pharmaceutical products. The Korean company’s first major M&A deal is scheduled to close by the end of 2020 and saw Celltrion pay Takeda an initial $266 million in cash, with up to an additional $12 million in milestone payments.
Later in June, the EMA’s Committee for Medicinal Products for Human Use approved Celltrion’s existing marketing authorization for Remsima (CT-P13)’s subcutaneous formulation (SC), an anti-inflammatory medicine to treat various immune-system diseases, for an additional five indications, including ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. Celltrion received EU marketing authorization for Remsima SC’s rheumatoid arthritis indication in November 2019.