Celltrion to announce Covid treatment Phase 2 trial results on Jan. 13
Celltrion will announce the results of Phase 2 clinical trials for its Covid-19 drug candidate on Jan. 13, the company confirmed Tuesday.
The data will be shared at an academic conference hosted by the Pharmaceutical Society of Korea that day.
Celltrion had completed Phase 2 clinical trials for CT-P59, or regdanvimab, last month. The tests were conducted on 327 patients with mild to moderate symptoms in Korea, Romania, Spain and the United States.
On Dec. 29, the company submitted an application to the Ministry of Food and Drug Safety to receive a conditional use permit which would make it an official coronavirus treatment distributed to local hospitals.
Celltrion had originally planned to disclose the results at the same time, but postponed the announcement citing an agreement with the Drug Safety Ministry. Considering the high level of public interest, the regulator had wished to review the data before the results were shared.
However, the Dec. 29 announcement from Celltrion and the Ministry of Food and Drug Safety met with criticism that regulators were reviewing the product without disclosing the clinical test results.
Korean Pharmacists for Democratic Society, a pharmacist activist group, argued that the process of authorizing CT-P59 should be transparent, leaving no room for controversy.
“Unlike the public hype surrounding Regkirona [CT-P59’s marketing name], zero documents have been disclosed regarding its clinical effects, unlike conventional new drugs for which test results are shared in academic papers and reviewed by the pharmaceutical society,” it said in a Dec. 31 statement.
According to media reports, the disclosure of the Phase 2 clinical data on Jan. 13 would be an earlier announcement than originally planned. A Celltrion spokesman confirmed the date is indeed earlier than what was being discussed with the government, but did not disclose when that original date was.
Regardless of the authorization process, Celltrion will carry out Phase 3 clinical trials for CT-P59, which is stipulated by the conditional use approval. The drug candidate has been authorized to start Phase 3 clinical trials in Korea, Romania, the United States, Britain, Spain and Italy.
BY SONG KYOUNG-SON [firstname.lastname@example.org]