HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.

“Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorization [EUA] for our drug,” said Sang Joon Lee, a senior executive vice president at Celltrion.

A company representative told BioWorld, “Korea is among the countries where an EUA application will be filed,” but declined to specify the other countries. The representative also said that Celltrion is planning to start production this month.

In partnership with Chungnam National University Hospital, Celltrion started the phase I, randomized, double-blind, placebo controlled, parallel group, single ascending-dose study with 32 volunteers who had not been diagnosed with COVID-19 by trial start in July. Completion of the study is expected in November. Celltrion is also recruiting participants for a second trial testing the antibody as a preventative treatment for those in close contact with COVID-19 patients.

CT-P59 works by neutralizing the virulent D614G variant of COVID-19, the variant associated with increased viral transmission and the 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 KCDC began an emergency search for a cure as Korea saw a surge of COVID-19 cases.

Celltrion began its COVID-19 antiviral journey by applying to KCDC’s program by the Feb. 27 deadline. KCDC approved the company’s participation on March 18, with the company reaching the halfway point in the development process later in the month. Korea’s Ministry of Food and Drug Safety (MFDS) approved the company’s investigational new drug application in July. A second approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to begin phase I trials followed in August.

With further global phase II and III trials involving 500 patients from 12 countries, including Korea, planned, the treatment is poised to tackle COVID-19 on a global scale. Celltrion hopes to complete the antibody’s development by the first half of 2021.

Celltrion’s COVID-19 pipeline also involves three rapid test kits, with the Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits launched in the U.S. in August. FDA approval is being sought for all three kits, with applications lodged for the Diatrust COVID-19 IgG/IgM rapid test on July 8 and the Sampinute COVID-19 Antigen MIA on July 24.

A joint production with health care startup BBB Tech Inc., the Sampinute COVID-19 Antigen MIA is a point-of-care antigen test that detects the SARS-CoV-2 antigen from nasopharyngeal swab samples. The Diatrust COVID-19 IgG/IgM rapid test, codeveloped with in vitro diagnostics developer Humasis Co. Ltd., is a one-step in vitro diagnostic test based on an immunochromatographic assay. Celltrion also plans to launch second-generation rapid antibody and antigen diagnostic kits, also co-developed with Humasis, later in 2020.

Meanwhile, fellow Korean biotechnology company ABL Bio Inc. is co-developing its own neutralizing antibody against COVID-19 with Cambridge, Mass.-based Hifibio Therapeutics Inc., with production targeted for mid-2021. The two companies filed an IND application with the FDA on Aug. 25 and expect to start early clinical trials in the U.S. in September.

Korea continues to make progress in its fight against COVID-19, with the Korea Disease Control and Prevention Agency (KDCA) reporting 109 cases within a 24-hour period as of midnight on Sept. 13. However, the Seoul metropolitan government’s ban on gatherings of 10 or more people will remain in place until Oct. 11.

Outside the COVID-19 sphere, three Celltrion biosimilars are currently in clinical trials, including Xolair (omalizumab) biosimilar CT-P39, Stelara (ustekinumab) biosimilar CT-P43 and Avastin (bevacizumab) biosimilar CT-P16.

Celltrion Group also signed an agreement in August with Intract Pharma Ltd. to jointly develop an oral tablet form of TNF-alpha inhibitor infliximab, or Remicade, developed by Johnson & Johnson subsidiary Janssen Pharmaceutical Cos. to treat autoimmune diseases.

The agreement signed between the two companies will see Celltrion “supplying the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies,” Bill Lindsay, Intract’s CEO, told BioWorld.

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