The Phase 1 study, conducted in collaboration with the TASK Clinical Research Center in South Africa, tested AKG-100 across various dose levels in 40 healthy volunteers and 15 tuberculosis patients. Participants tolerated doses as high as 850 mg without significant adverse events, marking a successful safety milestone for the drug’s lipid-nanoparticle delivery platform.

Beyond safety, the results indicate a promising shift in treatment efficacy. Exploratory analysis of the patient cohort revealed a 3.7 log10 reduction in bacterial burden by the 14th day, representing a 99.98% kill rate. Because AKG-100 operates independently of standard first-line antibiotics like rifampicin and isoniazid, it remains fully active against multidrug-resistant strains. Following these positive outcomes, Akagera Medicines has initiated a multiple-ascending-dose study to confirm the drug's potential for infrequent administration.