Celltrion said it plans to launch a clinical trial on a combination therapy of CT-P27, a new influenza antibody therapy to treat patients with influenza A, and the existing drug Tamiflu.
The Ministry of Food and Drug Safety on Monday approved the pharmaceutical firm’s plan for phase 2a clinical trial on CT-P27.
The study will compare two patient groups – one testing CT-P27 with neuraminidase-suppressing agents for patients infected with influenza A under the state of immunosuppression, and the other testing neuraminidase-suppressing agents only. The study will be randomized, double-blind, multi-institutional, placebo-controlled, and in parallel.
Patients recruited for the study will be those under the state of immunosuppression who were confirmed to have been infected with influenza A, and who spent more than 48 hours after the onset of their symptoms but not more than 96 hours. A total of 30 patients will participate in the study.
CT-P27 has been under Celltrion’s development as a new antibody drug for influenza A. In nonclinical and clinical trials jointly with the Center for Disease Control in the U.S., the new drug proved its efficacy on pandemic and seasonal influenzas, including bird flu that occurred in the past dozens of years. It also worked on most of the influenzas that have been transmitted to humans including H1, H2, H3, H5, H7, and H9.
Celltrion hopes that CT-P27 can replace existing flu treatments such as Tamiflu. The company aims to develop the new drug to treat all kinds of flu viruses.
In October last year, Celltrion received the ministry’ approval for the phase 2b clinical trial of CT-P27 to treat patients infected with acute influenza A, who did not develop complications. The study was to test the new drug’s safety and efficacy on 183 adult patients whose onset of the infection did not last more than two days.
“Including the clinical trial approved last year, we are conducting two clinical trials on CT-P27,” said a Celltrion official.
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