Vienna, Austria - April 12, 2010 - Nabriva Therapeutics today announced that it has successfully completed a series of Phase I clinical trials of its pleuromutilin antibiotic, BC-3781. BC-3781 is being developed for intravenous and oral treatment of skin and skin structure infections (SSSI) and community-acquired pneumonia (CAP). Data from some of these Phase I trials is being presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna as posters on Sunday, 11th April and in an oral presentation on Monday, 12th April.
The results of the clinical trials which began in July 2009 demonstrate that BC-3781 was safe and well tolerated up to the maximum doses tested. BC-3781 exhibits predictable pharmacokinetics in humans and the plasma levels achieved show that it has therapeutic potential for the treatment of skin and lung infections caused by bacteria. Nabriva will now progress BC-3781 into Phase II studies.
Dr. David Chiswell, CEO of Nabriva Therapeutics said: "BC-3781 is the first pleuromutilin to demonstrate safety, tolerability and therapeutic drug levels when administered systemically in humans. The phase I data show that BC-3781 can be delivered either orally or by intravenous infusion and that it has real potential to treat serious bacterial infections including those caused by organisms resistant to other antibiotics including MRSA and MDRP. We look forward to advancing clinical development into Phase II trials shortly.”
In total Nabriva will be presenting nine posters and one oral presentation at the conference. As well as the clinical data for BC-3781, the posters also cover BC-3205, another pleuromutilin being developed by Nabriva. Several posters focus on the detailed microbiology of both BC-3781 and BC-3205 with both pleuromutilins exhibiting excellent activity against a range of relevant bacteria including methicillin-resistant Staphylococcus aureus (MRSA). BC-3205 and BC-3781 also demonstrated superior efficacy in in vivo models compared to the standard care of antibiotics linezolid and vancomycin. In addition, posters demonstrating the methods to be used in the microbiological analysis of the upcoming Phase II trials will also be presented at the conference.
Presentations at ECCMID: Poster session Sunday, 11th April from 12:30-13:30 and an oral presentation on Monday, 12th April at 14:40
About Nabriva Therapeutics
Nabriva Therapeutics is a biotechnology company focused on developing a new class of antibiotics for the treatment of serious infections caused by resistant pathogens. Nabriva’s lead systemic product, BC-3781, is being developed for the treatment of serious skin infections and bacterial pneumonia caused by MRSA and other drug resistant bacteria. Extensive phase I data have demonstrated that BC-3781 can achieve therapeutically relevant blood and tissue levels in man with excellent tolerability when administered by either oral or intravenous routes. In addition, Nabriva Therapeutics’ topical pleuromutilin product candidate, BC-7013, is also in clinical phase I. Nabriva Therapeutics has a proven track record in world-class medicinal chemistry, clinical expertise, a seasoned management team and solid IP. Nabriva Therapeutics is located in Vienna, Austria.