Clinical-stage biopharmaceutical company Akagera Medicines Inc, together with the TASK Clinical Research Center in South Africa, on Monday announced positive results from the single-ascending-dose (SAD) portion of the first-in-human Phase 1 study of AKG-100, the company's investigational long-acting intravenous (IV) therapeutic being developed for the treatment of tuberculosis, including drug-resistant tuberculosis (DR-TB).

The SAD study evaluated single IV doses of AKG-100 across a range of dose levels in 40 healthy volunteers and 15 patients with pulmonary tuberculosis in a 14-day Early Bactericidal Activity (EBA) cohort. According to the company, AKG-100 was well tolerated at every dose studied, up to and including the highest dose of 850mg. The overall safety profile was favourable, with no participants discontinuing due to adverse events and most adverse events recorded as mild and self-limiting.

Akagera said that AKG-100 demonstrated a pharmacokinetic profile consistent with a long-acting profile. Following a single dose, drug concentration was maintained above the pre-specified target threshold for at least 14 days following a single administration, while the modelled concentration-time profiles support exposure being maintained over 28 days. The company added that these findings support the potential for dosing measured in weeks to months rather than every day. If confirmed in later studies, that profile would represent a significant departure from current treatment regimens, which require daily oral dosing for six months or longer and for which adherence over the full course remains one of the central challenges in tuberculosis care.

On the strength of these results, the multiple-ascending-dose (MAD) portion of the Phase 1 programme is now underway.