The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5. The readout followed the study’s interim results, which were announced in September, probing CT-P59’s safety, tolerability and pharmacokinetics, with the company ramping up CT-P59 production the same month.
“Celltrion is currently conducting global clinical phase II and III trials in several countries, including Korea, and plans to announce interim results for these trials by the end of 2020. In addition, the company aims to apply for global approval for preclinical trials involving close contacts of COVID-19 patients within 2021,” a Celltrion representative told BioWorld.
The recently-completed phase I studies showed that treating patients with CT-P59 resulted in at least 44% faster recovery time when compared with a placebo. CT-P59 was also well-tolerated with no clinically significant safety issues and no patients treated with the drug requiring hospitalization or other antiviral therapies as a result of COVID-19 so far, the company said.
The randomized, double-blind, placebo-controlled and parallel-group trial involved 18 patients with mild COVID-19 symptoms testing the antibody’s safety, tolerability and antiviral effect. Fifteen patients received 20mg/kg, 40mg/kg or 80mg/kg doses of CT-P59, with the remaining three patients receiving a matching placebo.
The company’s IND application for phase III trials to test CT-P59 on asymptomatic COVID-19 patients and close contacts of COVID-19 patients obtained approval from South Korea’s Ministry of Food and Drug Safety (MFDS) on Oct. 8.
With more than 50.7 million COVID-19 cases globally as of Nov. 9, according to Johns Hopkins University data, companies are racing to find a cure, either in vaccine or antibody form, as the numbers continue to rise.
The virus’ most famous victim so far, incumbent U.S. President Donald Trump, was treated with Regeneron Pharmaceuticals Inc.’s antibody cocktail REGN-CoV2 under compassionate use after his diagnosis in early October. The company recently announced that the U.K.’s independent data monitoring committee, on the basis of the data it analyzed from the Recovery trials, recommended the continuation of the U.K. trial studying REGN-CoV2 in hospitalized patients with COVID-19 and the continuous recruitment of eligible patients to all study arms.
Eli Lilly and Co. recently reached an agreement with the U.S. government to supply 300,000 vials of LY-CoV555 (bamlanivimab) for $375 million on Oct. 28, the same day that data from the monotherapy arms of Blaze-1, phase II study assessing the drug’s efficacy and safety was published in the New England Journal of Medicine. However, the company’s NIH-sponsored ACTIV-3 phase III trial testing LY-CoV555 and Veklury in hospitalized COVID-19 patients was paused and later halted after data showed it was unlikely to help advanced patients.
Closer to home for Celltrion, MFDS also approved Daewoong Pharmaceutical Co. Ltd.’s application to begin phase I trials for its COVID-19 drug candidate DWRX-2003 (niclosamide). The drug, repurposed from its original use as an anti-parasite drug, will be tested for tolerability and safety in healthy adults via a randomized, double-blind, placebo-controlled trial.
Another Korean company, ABL Bio Inc., is currently co-developing an antibody to neutralize COVID-19 alongside Cambridge, Mass.-based Hifibio Therapeutics Inc. The two companies filed an IND application with the FDA on Aug. 25, with production targeted to start in mid-2021.
Celltrion is not only working on a treatment to cure COVID-19, but also on three rapid test kits to diagnose the disease. The Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM test kits were launched in the U.S. in August, with FDA approval sought for all three test kits.
Celltrion also remains active in advancing candidates beyond COVID-19. Most recently, it presented results from for Humira (adalimumab) biosimilar CT-P17 at the American College of Rheumatology’s virtual annual meeting, Convergence 2020, which took place on Nov. 6 and 7. In its poster presentation, the company announced the results from two phase I trials with healthy patients, as well as a phase III trial involving rheumatoid arthritis patients.
The first phase I trial’s results showed that the biosimilar’s of pharmacokinetics and safety were equivalent to those of Humira. The second phase I trial compared the auto-injector and pre-filled syringe forms that CT-P17 is available in, with the results also confirming both forms’ pharmacokinetics and safety.
The phase III trials, involving patients with moderate to severe rheumatoid arthritis patients, tested the drug’s efficacy, pharmacokinetics and immunogenicity against the indication. The results from the 24-week long study showed that CT-P17’s efficacy, pharmacokinetics and immunogenicity were equivalent to those of to Humira.
Celltrion has applied for EMA’s approval to test CT-P17 against all Humira’s indications. EMA approval for thee indications, rheumatoid arthritis, ulcerative colitis, and psoriasis, is expected in 2021.