A single intravenous dose Phase 1 study in healthy volunteers showed that Juvabis’ EBL-1003 (apramycin) was safe and well tolerated in all dose groups. The results support further clinical development of EBL-1003 in patients.
“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 Dr. Sven Hobbie, CEO of Juvabis. “Several studies, both our own and those by independent researchers, have demonstrated the superior coverage of drug-resistant pathogens, and in particular Acinetobacter baumannii. EBL-1003 has the potential to replace aminoglycosides currently used in the clinic, but whose utility is seriously threatened by rising pan-aminoglycoside resistance.”
EBL-1003 is being developed in partnership with the European Gram-Negative Anti-Bacterial Engine (ENABLE), a project funded by the Innovative Medicines Initiative (IMI), as a treatment for infections caused by multidrug-resistant Gram-negative bacteria.
EBL-1003 is the only drug-candidate to have met the very strict requirements without any significant set-backs. Experienced pharmaceutical partners of ENABLE reviewed the progress of the Juvabis program and made regular “go/ no go” decisions (every 3 months). Of the initial set of drug candidates, only EBL-1003 consistently satisfied all the preclinical thresholds to proceed smoothly through development and into the clinic.
“Juvabis’ EBL-1003 programme is the most advanced within the ENABLE pipeline. The successful completion of this Phase 1 study is a very important milestone, and the ENABLE Project has now achieved all its initial key objectives,” said Anders Karlén, leader of ENABLE Managing Entity and professor at Uppsala University.
Robust data package
Juvabis was officially founded in 2015 as a spin-off from ETH Zurich and the University of Zürich. In only five years the team advanced their leading anti-infective drug to Phase 1 clinical trials. EBL-1003 is by now a largely de-risked, solid asset with a very robust and “Pharma-like” preclinical (and now Phase 1 clinical) data-package. In addition, Juvabis has a pipeline of innovative anti-infective products in pre-clinical development.
The biotech company strives to design next-generation aminoglycoside antibiotics that evade mechanisms of bacterial drug-resistance and at the same time display a superior safety profile when compared to benchmark drugs. A UZH proprietary technology platform of engineered ribosomes enabled the identification of apramycin’s favourable antimicrobial profile leading to the EBL-1003 R&D program, and also facilitated the rational design of a pipeline of additional next-generation aminoglycoside lead-scaffolds, which hold promise for addressing various infectious disease indications.
(Press release / SK)