Finally I have some good news to share. On a personal note, I have been working with Nabriva since 2005, well before they were spun out of Novartis’ Sandoz in Vienna in January 2006. I feel like their products are partly my children. Nabriva recently announced the completion of their phase II clinical trial in acute bacterial skin and skin structure infections (ABSSSI, as the FDA now says). This is the first such trial to be completed using the FDA designated guidelines as a template. Their data, when fully made public, will allow a comparison of the proposed FDA early endpoints to ultimate clinical outcome for the first time. (Hint – it might not be so straightforward). If you can’t tell – I am very proud of their achievement.
BC-3781 is the first pleuromutilin antibiotic to be efficacious in humans. Pleuromutilins were discovered around 1950 at Columbia University in New York. A pleuromutilin was approved for use in animals around 1979. In spite of many years of effort within many pharmaceutical c0mpanies, no one was able to identify a pleuromutilin that could be used systemically in humans prior to Nabriva’s program. This, by itself, is a remarkable achievement. BC-3781 is, in fact, the second pleuromutilin Nabriva has studied in clinical trials. BC-3205 was studied in a number of phase I trials in an oral formulation, but BC-3781 was taken all the way through phase II trials.