Akagera Medicines has reported positive data from the single-ascending dose (SAD) segment of its first-in-human Phase I trial of its lead candidate AKG-100, an investigational long-acting intravenous (IV) therapeutic targeting tuberculosis, including drug-resistant tuberculosis (DR-TB).
The study was conducted in partnership with the TASK Clinical Research Center in South Africa.
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It evaluated single IV doses of AKG-100 across various levels in 40 healthy participants and 15 patients with pulmonary tuberculosis in a 14-day early bactericidal activity (EBA) cohort.
AKG-100 was found to be well tolerated at all dose levels tested, up to a maximum of 850mg. Most adverse events reported were mild and self-limiting, and no participant discontinued due to adverse events.
Pharmacokinetic results showed that drug concentration remained above the pre-set target for at least 14 days after a single administration, and modelled data suggest exposure could be maintained for up to 28 days.
Company statements suggest this may support dosing schedules measured in weeks or months, as opposed to the current standard of daily oral dosing for six months or more.
An exploratory model-based analysis from the EBA cohort indicated that patients who received a single dose of AKG-100 experienced an estimated 3.7 log₁₀ reduction in bacterial burden by day 14, a result interpreted by the company as a bacterial killing of approximately 99.98%.
The same analysis showed a predicted increase of 298 hours in time to culture positivity from baseline by day 14.
Akagera Medicines noted that these findings are based on early and modelled data from single-dose cohorts.
On the basis of these results, the company confirmed that the multiple-ascending-dose phase of the Phase I programme has commenced.
Akagera Medicines chief medical officer Dr Sachin Marulkar said: “These first-in-human results are an important milestone for the patients who today face many months of daily treatment for tuberculosis.
“AKG-100 was well tolerated at every dose we studied, and its pharmacokinetic profile points toward dosing measured in months rather than days. If that profile holds through later studies, it could change what a course of DR-TB treatment looks like, particularly in the settings where the burden of this disease is greatest.”
AKG-100 is delivered via the company’s lipid-nanoparticle platform and is intended to provide sustained drug exposure with less frequent dosing.
The candidate is designed to remain active against both drug-susceptible and drug-resistant tuberculosis strains.
