June 03, 2019 09:00 AM Eastern Daylight Time
SEONGNAM-SI, South Korea–(BUSINESS WIRE)–Qurient Co. Ltd. today announced positive results from the Phase 2a EBA (early bactericidal activity) clinical trial for telacebec (Q203), a first-in-class, orally-available antibiotic for the treatment of tuberculosis (TB). Telacebec is a selective inhibitor with high specificity for the cytochrome bc1 complex of Mycobacterium tuberculosis. This complex is a critical component of the electron transport chain, and inhibition disrupts the bacterium’s ability to generate energy.
“Telacebec has been developed in response to the urgent need for new antibiotics to treat drug-resistant tuberculosis”
The EBA trial assessed the pharmacokinetics, safety, and activity of telacebec in three dose strength (100 mg, 200 mg and 300 mg) in the treatment of adult patients with pulmonary TB. Telacebec met the primary objective of rate of change in the time to positivity (TTP) in sputum over days 0 to 14. Telacebec was safe and well tolerated throughout the different dose strengths. Full results from EBA trial are expected to be presented at future scientific meetings.
“Telacebec has been developed in response to the urgent need for new antibiotics to treat drug-resistant tuberculosis,” said Kiyean Nam, Ph.D., CEO and CSO of Qurient. “The positive data from this trial is a significant milestone in developing an antibiotic with a novel mechanism of action that can benefit all TB patients. In addition, telacebec may have potential to treat buruli ulcer, another devastating infectious disease that is also part of the U.S. FDA’s priority review voucher program.”
Telacebec has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA. Telacebec also has been found effective against buruli ulcer (Mycobacterium ulcerans), a chronic, necrotizing disease that affects skin and sometimes bone and can lead to permanent deformity and long-term disability (Nature Communications, 2018).
This trial took place in South Africa and was led by global key opinion leaders in TB located in Cape Town, South Africa. Professor Andreas Diacon, a national principal investigator at TASK Applied Science, Doctor Veronique de Jager, principal investigator at TASK Applied Science, and Professor Rodney Dawson, principal investigator at University of Cape Town Lung Institute.
Telacebec is in Phase 2a clinical development under a U.S. IND (ClinicalTrials.gov: NCT03563599).
Qurient is a clinical-stage biopharmaceutical company listed in Korea Exchange (KRX 115180). Qurient has two programs in clinical development and one program in the IND enabling stage. Q301 is a topical leukotriene inhibitor for atopic dermatitis in a Phase 2b clinical trial in the United States. Q702 is a Axl/Mer/CSF1R triple inhibitor for immune-oncology and drug resistant non-small cell lung cancer, licensed from Max Planck Innovation and Lead Discovery Center in Germany. Telacebec (Q203), which just completed Phase 2a clinical trial, was licensed from Institute of Pasteur in Korea. For more info, please visit www.qurient.com.