Ongoing Projects

HOME > R&D Pipeline > Current status > Ongoing Projects

KDDF-201806-05 Phase 2 Clinical development of Q203: A novel drug candidate against MDR/XDR tuberculosis(Infectious Diseases, Chemical) [2019-02-22]

PRINT
Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Secure safety, tolerability, and activity of telacebec (Q203) through 14-day dosing in drug sensitive patients, which enables proceeding to late phase 2 studies in tuberculosis (TB) patients.

Unmet Medical Need & Target Patients

Target Patient Group

 

- Multi-drug resistant tuberculosis (MDR-TB) patients, who do not respond to current standard regimen.

Drug susceptible and resistant TB patients who can benefit from Q203 treatment.

 

Unmet Medical Needs

 

TB is a significant worldwide health problem. According to the World Health Organization (WHO), TB ranks as the second leading cause of death from an infectious disease worldwide, after the human immunodeficiency virus (HIV). Estimated 9.0 million people developed TB and 1.5 million died from the disease in 2013. In addition, globally, 3.5% of new and 20.5% of previously treated TB cases were estimated to have had multi-drug resistant TB (MDR-TB) or extensively drug resistant TB (XDR-TB) and global treatment success rate was only 48% and 22%, respectively. According to the Centers for Disease Control and Prevention (CDC) in the United States, the cost of hospitalization for one XDR-TB patient is estimated to average $483,000 USD.

 

There had been no new drug approved for TB in past forty years until 2012. Shortcomings of recently approved drugs against drug resistant TB [bedaquiline (SirturoTM, Janssen) and delaminid (DeltybaTM, Otsuka, approved by EMA in 2013)] include unavailability of clear combination dosing regimen and/or safety concerns (QTc interval prolongation, abnormal hepatic function and/or indreased risk of death). There is a need for additional medical therapies that act through novel mechanism of action in order to offer efficacy against both drug sensitive and drug resistant TB and to provide necessary options for combinational regimen, with an acceptable tolerability profile.

Status

Q203 has shown potent efficacy in TB animal model.

- 203 has shown potent bactericidal efficacy against MDR/XDR tuberculosis bacillus in clinical isolates.

- A novel mechanism of action - targeting the QcrB subunit of the cytochrome bc1 complex in the tuberculosis bacillus electron transfer system has been identified.

- Q203 has been shown safety through GLP toxicology and safety pharmacology studies in rodent and non-rodent species.

- Q203 has been approved and completed for Phase 1 clinical trial from U.S. FDA

Q203 has been designated as an Orphan Drug from U.S. FDA

 Phase 2 clinical studies are now in progress in South Africa.

Intellectual Property

Q203 patent is registered (Australia, China, EU, Israel, Japan, Russia, U.S, Singapore, and Hong Kong) and under review in 21 countries.

Competitive Advantages

- First-in-Class drug candidate: Q203 has a novel mechanism of action such that Q203 deplete energy metabolism of TB by inhibiting M.Tb. cytochrome bc1 complex specifically.

Strong efficacy: Q203 exhibits potent efficacy in chronic tuberculosis animal models at low dose strength.

Efficacy against drug resistant patient isolates: Q203 demonstrated strong efficacy against MDR/XDR TB patient isolates.

- High selectivity: Q203 is highly selective for M. tb. Cytochrome bc1 complex against it bacterial or mammalian counterparts.

- Potential improvement of patient quality of life: Q203 demonstrated reduction of post-infection inflammation in lung during the animal studies, which may lead to reduced degree of lung damage after treatment

- Relatively low COG: Relatively simple process route may lead to low COG in commercial production..

Safety: Q203 demonstrated good safety, tolerability, and PK profile in the phase 1 clinical studies.

Contact & Company Overview

Related Project

Related Project
list
Update to 2013 © KOREA DRUG DEVELOPMENT FUND. ALL RIGHTS RESERVED. QR Code