The study, conducted at the TASK clinical research site in Cape Town, South Africa, is a first-in-human single ascending dose (SAD) and multiple ascending dose (MAD) trial. It is assessing the safety and pharmacokinetics of AKG-100 in both healthy volunteers and pulmonary TB patients. The study will enroll approximately 100 participants.
Dr. Daryl Drummond, Chief Science Officer at Akagera Medicines, expressed optimism about the progress. 'The completion of the first cohort in this study is an important milestone as we progress a novel long-acting injectable and targeted treatment option for patients with pulmonary TB,' he said.
'AKG-100 demonstrated promising preclinical data, and we believe that its addition to drug-resistant TB treatment regimens will improve anti-TB activity and provide a favorable safety profile.'
Tuberculosis remains one of the world's deadliest infectious diseases, disproportionately affecting low-income populations. Despite being both preventable and treatable, TB continues to claim nearly two million lives each year, with 400,000 of these deaths occurring in children.
'TB is the greatest killer in human history. One out of seven people who ever lived has died from it. Nearly two million of the poorest people in Russia, India, Africa, and China die from it every year.' said Michael Fairbanks, Executive Chairman of Akagera Medicines.
AKG-100 is a pegylated liposomal formulation of an oxazolidinone antibiotic. Liposomal drug delivery systems offer significant advantages, including improved drug stability, increased drug solubility, and reduced toxicity.
'Liposome-encapsulated drugs are a promising area of drug delivery research. This formulation enhances drug efficacy by increasing uptake and retention by target cells, allowing for higher drug concentrations at the site of action,' explained Dr. Sachin Marulkar, Chief Medical Officer of Akagera Medicines.
The study's successful completion of its first cohort marks an important step in the development of a more effective TB treatment. AKG-100's long-acting injectable formulation is expected to provide much-needed flexibility and improve treatment adherence, especially in resource-limited settings.
Many TB patients struggle with the lengthy and demanding treatment regimens currently available, leading to poor compliance and the rise of drug-resistant strains.
Founded in 2018 in Kigali, Akagera Medicines is dedicated to developing innovative lipid nanoparticle formulations of antibacterial drugs and mRNA vaccines. In 2022, it established a 100%-owned subsidiary in Kigali for manufacturing and clinical trials.
Among its founding and current board members are Ambassador Dr. Albrecht Conze, Dr. Paul Farmer of Harvard Medical School, Dr. Donald Kaberuka, former Chair of the Global Fund for Malaria, HIV, and TB, and Dr. Eliane Ubalijoro, CEO of CIFOR-ICRAF. UN Ambassador Valentine Rugwabiza and Philippe Watrin, Chief Investment Officer of the RSSB, also serve on the board.
Task clinical research, which is conducting the trial, is a leading multinational research institute based in Cape Town, South Africa. It has completed over 100 clinical studies focused on infectious diseases.
It is led by Professor Andreas Diacon, a recognized expert in TB research who received the 2016 Scientific Prize from the International Union Against Tuberculosis and Lung Disease.
The global burden of TB extends beyond human health, with significant economic and geopolitical implications. TB-infected mothers are associated with a six-fold increase in perinatal deaths.
The World Health Organization warns that a large TB infection pool, coupled with factors such as drug resistance and inadequate case detection, continues to fuel the epidemic.
Political conflicts further complicate efforts to control TB, while the disease also poses a direct threat to wildlife. Many animal species, particularly primates, are vulnerable to TB due to increased exposure to eco-tourists.
IGIHE
