Celltrion

Main menu

Press Release

Celltrion announces positive data from phase 1 trial of a novel therapeutic antibody CT-P27.

2013.11.20

Celltrion announces positive data from phase 1 trial of a novel therapeutic antibody CT-P27.

Phase 1 clinical trial for CT-P27, a therapeutic antibody for treatment against universal influenza, has been revealed and confirmed to be “safe” and “well-tolerated”.
- Phase 2 clinical trials are planned to start in the first half of next year and is expected to be commercialized in 2015.

Celltrion announced that the company had successfully completed phase 1 clinical trial for CT-P27, a novel therapeutic antibody under development. CT-P27 is a therapeutic antibody for treatment against universal influenza which is attracting attention from the US and Chinese governments for its ability to neutralize a broad spectrum of influenza virus subtypes.

On November 18th, 2013 Celltrion announced positive clinical trial phase 1 data of CT-P27. Starting from May of this year, 31 healthy adults were subjected to CT-P27 by Celltrion to confirm the safety of CT-P27. Treatment-Emergent Adverse Event (TEAE), vital signs, electrocardiography, laboratory tests were observed after single doses of CT-P27 administration of a 90 minute I.V. infusion and the result showed CT-P27 to be safe and well-tolerated within the first 7 days. Even infusions of up to 20 mg/kg dose levels proved to be tolerable.

The phase 1 clinical trial has confirmed safety dose levels and CT-P27’s half-life of 6 days is sufficient for the treatment of influenza virus. Celltrion intends to conduct phase 2 clinical trials in the UK in first half of 2014.

An official from Celltrion explained: “The efficacy tests for CT-P27 are to be conducted in the first half of 2014 and we anticipate commercialization of CT-P27 by the first half of 2015, if not earlier due to emergency requests by governmental agencies.” CT-P27 is Celltrion’s first novel therapeutic antibody candidate to undergo clinical trials. Celltrion is a leading biopharmaceutical company, specializing in monoclonal antibody biosimilars and novel biopharmaceuticals. Celltrion’s RemsimaTM received EU approval as world’s first biosimilar mAb.

If successfully developed and commercialized, the potential market size is substantial. In 2009, when there was an outbreak of Swine flu (A/California/04/09(H1N1)), Tamiflu and Relenza recorded total sales of KRW 180 billion in Korea. In the same year, Roche’s Tamiflu recorded sales of more than USD 3 billion globally.

CT-P27 has demonstrated efficacy over various epidemic and seasonal influenza subtypes affecting humans including most of the avian influenza subtypes (H1, H2, H3, H5, H7, H9) through in vitro and in vivo experiments utilizing animals. Chinese expert groups, in particular, are further testing CT-P27 as CT-P27was identified to have the ability to neutralize the recent strand of Chinese avian flu (H7N9).

Moreover, due to CT-P27 using a different mode of action from the existing influenza treatments, CT-P27 has the ability to neutralize influenza viruses that have become resistant to currently existing treatments such as Tamiflu or Relenza. According to a 2009 report from the World Health Organization (WHO), more than 50% of North American and Western European H1N1 influenza virus strains showed resistance to Tamiflu.Influenza viruses undergo high mutation rates and frequent genetic re-assortment. Vaccines, due to their certain modes of action, have limitations in preventing outbreaks of influenza. When lethal viruses become pandemic, it takes a significant period of time to manufacture appropriate vaccines for treatment of such pandemic viruses, but antibodies can be directly used to treat the virus. If properly developed, CT-P27 could be selected as government stockpiling medicine.

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, has also expressed considerable interest in CT-P27 and requested that clinical trial results be shared. BARDA provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies as part of its program to support development projects. 

위로 가기