HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.

MFDS gave the green light on Oct. 8 to Celltrion’s investigative new drug application for phase III trials to test CT-P59 on asymptomatic COVID-19 patients and close contacts of COVID-19 patients. The South Korean company is now in the process of recruiting up to 1,000 patients for the trial, a company spokesperson told BioWorld, with “the trials start time dependent on the recruitment process.”

Sang Joon Lee, a senior executive vice president at Celltrion, said, “MFDS’s latest approval follows approvals for phase II and III clinical trials to test CT-P59 in mild and moderate patients, and allows us to move ahead with clinical trials for CT-P59. These trials for asymptomatic COVID-19 patients and close contacts of COVID-19 patients will prove the importance of early diagnosis and early treatment, and hopefully play a role in preventing the spread of COVID-19 and its eradication.”

Celltrion released the interim results from a phase I study testing CT-P59 in healthy subjects in September, which confirmed the antibody’s safety, tolerability and pharmacokinetics. The results boosted confidence in the candidate, with the company ramping up production of the antibody in the same month.

The phase I, randomized, double-blind, placebo controlled, parallel group, single ascending-dose study, done in partnership with Chungnam National University Hospital, studied CT-P59’s impact on 32 participants who have not been diagnosed with COVID-19 when the trial started in July. Celltrion hopes to wrap up the study by November, and “should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorization for our drug,” Lee said. With the company planning further global phase II and phase III trials in 12 countries, including Korea, Celltrion hopes to complete the antibody’s development by the first half of 2021.

Celltrion began CT-P59’s development process after participating in the Korea Centers for Disease Control and Prevention (KCDC)’s emergency search for a cure as Korea saw a surge of COVID-19 cases in February, winning approval to pursue it on March 18. The company noted progress on the project later that month, gaining IND approval from MFDS in July. Celltrion scored a second clinical trials approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to begin phase I trials a month later.

Celltrion is not the only company flying the flag for Korea in the race to develop a COVID-19 cure. MFDS also greenlighted phase I trials in Korea for Daewoong Pharmaceutical Co. Ltd.’s COVID-19 drug candidate, DWRX-2003 (niclosamide), alongside its approval for CT-P59. Repurposed from its original use as an anti-parasite drug, DWRX-2003’s tolerability and safety in healthy adults will be tested via a randomized, double-blind, placebo-controlled trial. Outside Korea, Daewoong began phase I trials in India in August, receiving approval to run another phase I program in the Philippines a month later.

A third Korean company, ABL Bio Inc., is co-developing an antibody to neutralize COVID-19 together with Cambridge, Mass.-based Hifibio Therapeutics Inc. The two companies filed an IND application with the FDA on Aug. 25, and ABL targets starting production in mid-2021.

Meanwhile, Celltrion’s contribution to the fight against COVID-19 also includes three rapid test kits, with the company launching the Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits in the U.S. in August. It is seeking FDA approval for all three kits, with applications filed for the Diatrust COVID-19 IgG/IgM rapid test on July 8 and the Sampinute COVID-19 Antigen MIA on July 24.

The company has also been keeping busy with its pipeline outside COVID-19, with three Celltrion biosimilars currently in the clinic. The biosimilars are Xolair (omalizumab) biosimilar CT-P39, Stelara (ustekinumab) biosimilar CT-P43 and Avastin (bevacizumab) biosimilar CT-P16.

Celltrion Group, which includes both Celltiron Inc. and Celltrion Healthcare Co. Ltd., inked an agreement with Intract Pharma Ltd. in August to jointly develop an oral tablet form of TNF-alpha inhibitor infliximab. Also known as Remicade, the drug was developed by Johnson & Johnson arm Janssen Pharmaceutical Cos. to treat autoimmune diseases.

The fight against COVID-19 goes on, with South Korea reporting 97 new cases on Monday and the number of global cases approaching 37.5 million as of Oct. 12, according to Johns Hopkins University data.

Celltrion has enough confidence in CT-P59 to ramp up production from September onward.

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