Celltrion said Wednesday that it has finished administering its pipeline CT-P59 (regdanvimab) to all 327 patients enrolled in the global phase 2 clinical trials held across South Korea, the US, Romania and Spain. Upon news of the company’s imminent application for emergency use of its COVID-19 antibody treatment, shares of Celltrion jumped immediately.
This phase 2 clinical trial targets lightly and seriously afflicted COVID-19 patients, and is being carried out to ascertain the safety and efficacy of Celltrion’s COVID-19 treatment.
The cohorts for the trial were divided three ways: those given a placebo, those given a low concentration of the pipeline and those given a high concentration.
As soon as an interim result is available, Celltrion will apply for conditional approval of CT-P59 in the medical forefronts from the Ministry of Food and Drug Safety.
Celltrion Chairman Seo Jung-jin was quoted in an interview with local daily Hankyoreh on Wednesday as saying the application is to be submitted at end-December, enabling the drug to hit the market early next year.
“Come spring, Korea will become the first country in the world where people can go about without wearing masks,” Seo was quoted as saying.
Celltrion has already started manufacturing the drug for some 100,000 people preemptively before the Drug Ministry’s approval.
The company is also getting ready to enter the next phase of development -- phase 3 clinical trials -- which it plans to carry out in 10 countries.
Celltrion’s press release stated that the company expects to manufacture CT-P59 for a maximum of 2 million people per year.
Chong Kun Dang, a more traditional pharmaceutical firm in Korea, also moved a step forward Wednesday in its global tests to repurpose anticoagulant drug Nafabeltan (nafamostat) as an antiviral COVID-19 therapy.
Nafabeltan was cleared to proceed to its phase 2 clinical trial in Mexico, where the authorities plan on using the drug on some 118 patients experiencing serious respiratory symptoms due to the coronavirus.
This is another country added to CKD’s global endeavors following a phase 2 trial design approval in Russia in September. In Russia, the trial is on track at some 12 medical institutions, CKD said.
CKD’s overseas trials reflect the high number of COVID-19 patients in those countries, denoting the urgent need for a treatment, and a correspondingly large pool of clinical trial participants.
Daewoong Pharmaceutical, another player repurposing an existing drug for COVID-19 treatment, said Monday that it has finished recruiting participants for its domestic clinical phase 2 trial.
Daewoong said it expects to be able to market Foistar tablets (camostat) as a COVID-19 drug starting in January.
According to the Ministry of Food and Drug Safety’s latest report, there are currently 19 proposed COVID-19 therapies that are undergoing clinical trials in Korea.
Among them, five pipelines are in phase 1 trials, 10 in phase 2 trials and two in phase 3 trials.
Those in phase 2 trials are Bukwang Pharm’s Levovir capsule (clevudine), Enzychem Lifesciences’ EC-18, Shin Poong Pharm’s anti-malaria treatment Pyramax (pyronaridine-artesunate), Chong Kun Dang’s CKD-314 (camostat), CrystalGenomics’ CG-CAM20 (camostat), Daewoong Pharmaceutical’s DW1248 (camostat), GC Pharma’s blood plasma-derived therapy GC5131, Celltrion’s CT-P59, MSD Korea’s MK-4482 (molnupiravir) and Dongwha Pharm’s DW2008S.
Those in phase 3 trials are Eli Lilly’s LY3009104 (baricitinib) and Celltrion’s CT-P59.
By Lim Jeong-yeo(firstname.lastname@example.org