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FDA nods Qurient’s multidrug-resistant TB treatment for P2 clinical trials
  • By Lee Han-soo
  • Published 2018.07.16 15:10
  • Updated 2018.07.16 15:10
  • comments 0

Qurient said Monday that the U.S. Food and Drug Administration (FDA) has approved phase 2 clinical trial for Telacebec, a multidrug-resistant tuberculosis treatment, in the U.S.

Multidrug-resistant tuberculosis refers to tuberculosis resistant to various antibiotics. The disease has a mortality rate of 30 to 50 percent. Given the seriousness of these diseases, the FDA is encouraging research into a treatment for the illness by granting a PRV (Priority Review Voucher).

Fifty-four patients will participate in the initial phase 2 clinical trial. The company plans to administer the three doses that have confirmed its safety in phase 1 clinical trial.

In an animal experiment, the company also confirmed that Telacebec kills 99.9 percent of mycobacteria in the lungs within four weeks. Professors Andreas Diacon and Rodney Dawson, both world-renowned experts in clinical trials for tuberculosis treatment, will be in charge of running Qurient’s phase 2 clinical trial.

“In cases of multidrug-resistant tuberculosis, the severity of the disease is high and conditional approval is possible in most countries after completion of phase II clinical trials,” a company official said. “As the drug has received U.S. FDA approval, the phase 2 clinical trials can lead to the company obtaining a PRV.”

corea022@docdocdoc.co.kr

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