AKAGERA Medicines Inc, a biotech company developing novel lipid nanoparticle formulations of antibacterial drugs and mRNA vaccines to treat tuberculosis, avian flu, RSV and other infectious diseases, announced on Tuesday that it has completed the first cohort in its first-in-human phase 1 SAD/MAD study of AKG-100.
AKG-100 is an oxazolidinone class of antibiotic intended for treatment of pulmonary tuberculosis (TB).
The study consists of single ascending dosing (SAD) and multiple ascending dosing (MAD) to establish the safety and pharmacokinetics of AKG-100 alone in single doses in healthy volunteers and pulmonary TB patients as well as in multiple doses in pulmonary TB patients. Approximately 100 participants will be enrolled in the study, which is being conducted at TASK clinical research site in Cape Town, South Africa..
AKAGERA Medicines is supported by the Coalition for Epidemic Preparedness Innovations (CEPI) in Norway, the Bill and Melinda Gates Foundation, the National Institute of Health (NIH) in Washington and the European Investment Bank (EIB) in Luxembourg.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA