HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials.

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the treatment its approval to begin phase I trials on the heels of Korea’s Ministry of Food and Drug Safety (MFDS) approving the company’s investigational new drug application on the back of positive preclinical results in July.

A MHRA spokesman told BioWorld, “We are currently offering an expedited review and approvals process for COVID-19 clinical trials. While COVID-19 applications are being prioritized, the trials are being reviewed according to quality and safety requirements, in liaison with an expert advisory group of the Commission on Human Medicines.”

Sang Joon Lee, senior executive vice president of Celltrion, told BioWorld, “We were able to secure MHRA approval after close discussions with British regulators. We are currently aiming to recruit around 50 COVID-19 patients in total for both trials in the U.K. and Korea, although this number is subject to change. Both trials will test the treatment’s safety, tolerability and virology, pharmacokinetics and immunogenicity.”

The Korean phase I trial sees 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, with completion targeted by the third quarter of 2020.

The company aims to have interim results from both phase I trials by the end of 2020, but the length of the trial will be dependent on the patient recruitment process. An additional trial involving close contacts of COVID-19 patients is scheduled to start within the year, with results expected by the first quarter of 2021.

To add to this, Celltrion aims to expand CT-P59’s global range even further. Lee said that final discussions with countries in Europe and elsewhere are taking place in preparation for global phase II and phase III trials. He declined to name the countries as the negotiations are ongoing.

One of the countries in the list could be Brazil. Celltrion CEO Jung-Jin Seo said in a press conference earlier in the month that the company is “carefully examining” the possibility of trials in the country, although Celltrion had not yet initiated discussions with the Brazilian government at that point.

CT-P59 works by neutralizing the virulent D614G variant of COVID-19, the variant associated with increased viral transmission and wide spread of the virus. Celltrion won approval to develop a COVID-19 cure from the Korea Centers for Disease Control and Prevention (KCDC) on March 18, after the body began an emergency search for a cure as Korea saw a surge of COVID-19 cases.

The company reached the difficult halfway point in the CT-P59’s development process in late March, after building a 300-antibody library from blood samples that were collected from recovered patients.

Seo took a personal interest in the treatment’s development even before the company won the KCDC mandate. He also made headlines for Celltrion and CT-P59 after saying that the company would start mass manufacturing the treatment for clinical trials and commercial distribution, despite its relatively early stage of development. Although Seo will be retiring at the end of the year, he said he did not expect his retirement to have an impact on CT-P59’s development.

CT-P59 is not the sole product in Celltrion’s COVID-19 pipeline, with the company currently in the process of applying for FDA approval for three test kits. Its rapid antibody diagnostic testing kit, developed in partnership with in vitro diagnostics developer Humasis, is set to be launched 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, with CE certification to be applied for in August. Celltrion applied for CE certification for its point-of-care antigen test kit, developed with health care startup BBB Inc., in June and plans to launch the kit in August.

Meanwhile, Celltrion has keeping busy outside of the COVID-19 sphere. Three biosimilars are currently in clinical trials, including Xolair (omalizumab) biosimilar CT-P39, Stelara (ustekinumab) biosimilar CT-P43 and Avastin (bevacizumab) biosimilar CT-P16. Celltrion applied for EMA approval for CT-P17, its Humira biosimilar, in March.

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.

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