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Development of Telacebec for Buruli Ulcer

Award type :
Product Development Award
Product type :
Therapeutics
Award year :
2025
Project start date :
08 / 13 / 2025
Project end date :
-
Project duration (months) :
-
Development stage :
Phase 2
Target disease :
Buruli Ulcer
Region served :
West Africa, Central and East Asia, the Pacific (excluding high-income countries), Australia
Recipient organization / Country of funding recipient organization :
Global Alliance for TB Drug Development (TB Alliance) / USA
Collaborator(s) / Country :
Qurient / Republic of Korea, Barwon Health / Australia
Funding amount(KRW) :
2,885,030,618

TB Alliance, in collaboration with Korean innovator Qurient and Barwon Health, is developing telacebec for Buruli ulcer, a neglected tropical disease caused by Mycobacterium ulcerans that primarily affects children under 15 in sub-Saharan Africa. Current standard treatment requires once-daily rifampicin and twice-daily clarithromycin for eight weeks, creating burdens due to lengthy duration, complex administration, and poor adherence. Telacebec, originally discovered by Qurient for tuberculosis and with demonstrated Phase I and II safety, shows exceptional potency against M. ulcerans in preclinical studies, suggesting potential for simplified four-week monotherapy. This Phase II trial in Australia will enroll approximately 80 adults with broader inclusion criteria than previous studies to demonstrate safety and efficacy, including pharmacokinetic analysis to support future pediatric dosing. The streamlined treatment could improve adherence, reduce healthcare burden, and accelerate healing while supporting antibiotic stewardship through targeted mycobacterial activity.