Juvabis has achieved an important milestone in the development of an innovative antibiotic: according to a press release, a Phase I study is to be launched. This means that the promising drug candidate will now be tested in a small study on healthy humans to ascertain its tolerability and safety profile. The results will be presented at some point in the next year.
The database of artificially engineered ribosomes developed by the University of Zurich (UZH) led to the identification of the favorable antimicrobial profile of apramycin. Juvabis is a spin-off affiliated with UZH and has since acquired an exclusive worldwide license from UZH for the commercialization of apramycin in human therapy.
In 2016, UZH and Juvabis joined forces with the ENABLE consortium. A 6-year project was set up involving a total of 40 European partners from the worlds of science and industry. The project is based at Uppsala University, Sweden, and is being funded by the Innovative Medicines Initiative (IMI). The aim is to develop novel antibiotics against key Gram-negative bacteria. Apramycin is the only ENABLE drug candidate to progress to a Stage I study so far. This increases its chances of success enormously. According to a press release issued by the IMI, apramycin is by far the most promising drug across the entire project.
The best-in-class potential of apramycin has been underlined by the results of preclinical profiling, Juvabis CEO Sven Hobbie comments in a press release issued by ENBALE. “Our close collaboration with ENABLE has been of critical importance to our rapid progress”, he explained. Pierre Meulien, Executive Director of IMI, also emphasized the role of this project: “Developing new antibiotics is extremely difficult”, although the project partners were successful in their efforts to rapidly accelerate the development of this potential new antibiotic.
A total of three study phases must be successfully conducted before a drug can receive market authorization. In the past 30 years, just two new classes of antibiotics have managed this. However, entry into a Phase I study represents a decisive step on this journey.