A study in healthy volunteers showed that the antibiotic EBL-1003 is safe and well tolerated. EBL-1003 shows promise as a treatment for complex drug-resistant infections.
The early stages of antibiotic development are extremely challenging. IMI’s ENABLE project set up an antibiotic development platform to provide researchers with the expertise, resources and support needed to advance promising early research stage antibiotics into Phase 1 clinical trials in humans. It focused in particular on antibiotics developed by teams in universities and small and medium-sized enterprises (SMEs).
The clinical potential of apramycin was discovered by researchers at the University of Zurich who set up a spin-out company, Juvabis, to develop it further. Juvabis joined ENABLE in 2016. Thanks to the collaboration with ENABLE, Juvabis was able to demonstrate the safety and efficacy of EBL-1003 (a purified form of apramycin) in animal models for various infections, including infections caused by some of the more dangerous drug-resistant bacteria.
ENABLE selected EBL-1003 as a clinical candidate in late 2018, and the Phase I clinical trial started a year later. The goal of the trial was to assess the safety and tolerability of the drug as well as how it behaves in the body. Healthy volunteers received single intravenous doses or a placebo.
The results of that trial are now in, and they show that EBL-1003 is both safe and well tolerated. The Juvabis team now plans to run a further Phase I trial in patients with complicated urinary tract infections – one of the disease areas where EBL-1003 shows the most promise.
‘The safety, tolerability and pharmacokinetic results in this first-in-human study are very encouraging and clearly support our commitment to progressing the clinical development of EBL-1003,’ said Juvabis CEO Dr Sven Hobbie.
If further trials confirm EBL-1003’s antibiotic abilities, it would be a valuable weapon for treating infections involving bacteria that are increasingly resistant to many existing antibiotics.
‘We urgently need new antibiotics to tackle the ever-growing threat of antimicrobial resistance. ENABLE’s successes demonstrate that with the right support from a team of experts from academia and industry, potential antibiotics can be identified and supported through the highly challenging early stages of antibiotic development,’ said IMI Executive Director Dr Pierre Meulien. ‘More broadly, this result demonstrates the strength of public-private partnerships in tackling major health challenges.’