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.
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).
About Qurient
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.
Contacts
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