• April 2, 2020

Qurient Announces Publication in New England Journal of Medicine of Phase 2 Data for Telacebec, a First-in-Class Antibiotic for the Treatment of Tuberculosis - Odessa American: Business

e-Edition Subscribe

Qurient Announces Publication in New England Journal of Medicine of Phase 2 Data for Telacebec, a First-in-Class Antibiotic for the Treatment of Tuberculosis

Print
Font Size:
Default font size
Larger font size

Posted: Wednesday, March 25, 2020 6:05 pm

SEONGNAM-SI, Korea--(BUSINESS WIRE)--Mar 25, 2020--

Qurient Co. Ltd. today announced the publication in the New England Journal of Medicine (NEJM) of positive results from the Phase 2 clinical trial for telacebec (Q203), a first-in-class, orally available antibiotic for the treatment of tuberculosis (TB).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200325005779/en/

Time to positivity test shows clear early bactericidal activity across dose and time. A daily increase in log10 time to positivity of 0.0036 (95% confidence interval [CI], 0.0013 to 0.0060), 0.0087 (95% CI, 0.0064 to 0.0110), and 0.0135 (95% CI, 0.0112 to 0.0158) for telacebec at a dose of 100 mg, 200 mg, and 300 mg, respectively. (Graphic: Business Wire)

TB is a serious bacterial infection that mainly affects the lungs and remains one of the top 10 causes of death worldwide. In 2018, approximately 10 million people were sickened by TB, and 1.5 million died. The World Health Organization reported that 484,000 people with TB showed resistance to rifampicin in 2018.

The Phase 2 clinical study for telacebec (Q203) was a prospective, randomized, open-label trial involving 61 patients with newly diagnosed, rifampicin- and isoniazid-susceptible pulmonary tuberculosis. Patients were assigned to receive 14 days of oral telacebec at a dose of 100 mg, 200 mg, or 300 mg once daily or combination therapy with rifampicin, isoniazid, pyrazinamide, and ethambutol (RHZE). Serial (16-hour) sputum samples were collected daily, and time to positivity in liquid culture was measured in hours.

Increasing doses of telacebec were associated with greater reductions in viable bacterial load in sputum. The primary endpoint data showed a daily increase in the time samples required to become culture positive after sputum inoculation. This shows that daily treatment with telacebec is able to reduce the number of live M. tuberculosis in a dose dependent manner, with greater activity for increasing doses including 100 mg, 200 mg and 300 mg daily.

Telacebec was associated with acceptable adverse-event rates, and adverse events were equally distributed among all groups. There were no serious adverse drug reactions and no adverse drug reactions that resulted in early withdrawal from the study.

This trial took place in South Africa under a U.S. IND (ClinicalTrials.gov: NCT03563599) 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.

“We are very excited to achieve clinical proof-of-concept for telacebec, a new class of anti-tuberculosis agent,” said Kiyean Nam, Ph.D., CEO and CSO of Qurient.“This publication is recognized by global academics for the excellent clinical results of telacebec and provides hope to realize the first ‘100% effective regimen,’ making the distinction between drug-susceptible and drug-resistant TB obsolete.”

About Telacebec (Q203)

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 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 ).

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, Q901 is a selective CDK7 inhibitor for oncology, these two program were licensed from Max Planck Innovation and Lead Discovery Center in Germany. Telacebec (Q203), which just completed a Phase 2 clinical trial, was licensed from Institute Pasteur Korea. For more info, please visit www.qurient.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20200325005779/en/

CONTACT: Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com

+1.858.344.8091

KEYWORD: AFRICA SOUTH KOREA SOUTH AFRICA ASIA PACIFIC

INDUSTRY KEYWORD: GENERAL HEALTH INFECTIOUS DISEASES HEALTH PHARMACEUTICAL CLINICAL TRIALS

SOURCE: Qurient Co. Ltd.

Copyright Business Wire 2020.

PUB: 03/25/2020 07:06 PM/DISC: 03/25/2020 07:05 PM

http://www.businesswire.com/news/home/20200325005779/en

© 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Odessa, TX

Current Conditions

Clear
78°
Humidity: 15%
Winds: W at 9mph
Feels Like: 78°

Your Extended Forecast

Tomorrow

weather
High 86°/Low 55°
Mainly clear. Lows overnight in the mid 50s.

friday

weather
High 67°/Low 42°
Partly cloudy. Highs in the upper 60s and lows in the low 40s.

saturday

weather
High 58°/Low 48°
Showers ending by midday. Highs in the upper 50s and lows in the upper 40s.
Online Features

Pet Central

pets

Having a pet is a lot of responsibility, and we’ll help by giving you lots of tips and tricks! More >>

Fitness

Fitness

Our fitness articles will help teach you how to work out with gym- and home-based exercises. More >>

Crosswords

Crosswords

Enjoy the crosswords challenge in our free daily puzzles, from the harder Sunday crossword to the quicker daily. More >>

Sudoku

Sudoku

Every Sudoku has a unique solution that can be reached logically. Enter numbers into the blank spaces so that each row, column and 3x3 box contains the numbers 1 to 9. More >>




  • ALL-ACCESS: Subscribe to our e-edition and premium website at myoaoa.com.
    You can read your daily newspaper without taking a walk to the driveway.
    Look back at yesterday's newspaper, or issues from months ago with our archive feature.
    Call circulation at 432-337-7314 to sign up today.