AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, has announced the start of a new clinical programme with AIC499, an innovative beta-lactam antibiotic against a broad range of multidrug-resistant (MDR) Gram-negative bacteria in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
As a first step in the clinical development, the first-in-human Phase I trial is currently ongoing to primarily evaluate the safety, tolerability and pharmacokinetics of single ascending doses of intravenous AIC499.
The study is randomised, single-blind, placebo-controlled and conducted in 48 healthy volunteers in a single centre at the Medical University of Vienna, Austria. This single dose part will be followed by a multiple ascending dose part in 36 volunteers.
The Phase I and Phase II clinical development of AIC499 is being supported by the Innovative Medicines Initiative (IMI) within the COMBACTE-MAGNET project.
COMBACTE MAGNET is a highly innovative programme in which the academic and private partners across Europe, including AiCuris and the Medical University of Vienna, are collaborating to combat the threat of antimicrobial resistance in Gram-negative bacteria worldwide.
"As an EFPIA partner providing AIC499 in COMBACTE-MAGNET, we are delighted to initiate the next step in the development of our novel resistance-breaking antibiotic with the support from IMI. In combination with a beta-lactamase inhibitor (BLI), AIC499 has already shown very potent antibacterial preclinical activity against Gram-negative pathogens," said Dr Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH.
"Gram-negative pathogens are considered to be amongst the most serious threats to public health and a major unmet medical need. We are convinced that, with its unique profile and extensive coverage, AIC499 has the potential to become a highly effective antibiotic for patients with severe infections including those caused by multi-resistant pathogens. We are expecting first results from this Phase I study in mid-2017."