Q203

Partners: ERA4TB, Qurient Therapeutics, National Center for Advancing Translational Sciences (NCATS)

Background:

Telacebec (Q203) is a first-in-class drug candidate against Mycobacterium tuberculosis infection. Telacebec (Q203) targets cytochrome bc1 complex and shows potent activity against multidrug-resistant tuberculosis (MDR-TB).

Telacebec(Q203) 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.

About Buruli Ulcer
Found primarily in West Africa and Australia, Buruli ulcer is a rare bacterial infection of the skin and soft tissue caused by the Mycobacterium ulcerans. Starting as painless swelling of affected areas, it often leads to the development of disfiguring ulcers and skin loss. Currently, treating Buruli ulcer requires up to eight weeks of treatment with a combination of dual antibiotic therapy that has a high incidence of side effects, including liver damage. The ulcers caused by the disease also often take months to heal even after use of antibiotics.

About the BU Phase 2 Trial
In July 2024, a Phase 2 proof-of-concept study was initiated to explore the use of telacebec (Q203) to treat Buruli ulcer. If successful, a single drug could cut treatment duration by more than half. In partnership with TB Alliance and with support from Qurient Co. Ltd, Professor Daniel O’Brien – a prominent clinician-researcher and expert in Buruli ulcer – is leading the study at Barwon Health and the Royal Melbourne Hospital in Australia. The trial will enroll approximately 40 adult patients with Buruli ulcer who will receive 28 days of telacebec (300mg) once daily, followed by a year of observation. Preliminary results are expected in 2025.

Phase 2

Trial Components

Solo Compounds