Systemic Pleuromutilin BC-3781

BC-3781 belong to the first generation of pleuromutilins to combine excellent sytemic bioavailability with substantial activity against gram-positive pathogens and atypicals as well as some gram-negative pathogens.  In particular it is highly active against multi-drug resistant (MDR) pathogens including methicillin resistant Staphylococcus aureus (MRSA), MDR Streptococcus pneumonia, and vancomycin resistant Enterococcus faecium. It has excellent in vivo activities, outstanding PK/PD parameters, and a novel mode of action.

Regulatory Stage

BC-3781, is being developed for both oral and IV administration. Following extensive Phase I data becoming available in 2009, BC-3781 is expected to enter Phase II trials in 2010  for the treatment of  serious multi-drug resistant skin & skin structure infections (now called ABSSSI, Acute Bacterial Skin and Skin Structure Infections).

Topical Pleuromutilin BC-7013

Nabriva is developing the pleuromutilins for  topical application. BC-7013 is the most advanced drug candidate. BC-7013 belongs to a subclass of pleuromutilins which are characterized by outstanding activities against resistant gram-positive pathogens, in particular MRSA, and excellent PK/PD parameters in skin. BC-7013 is being developed for the topical treatment of a number of bacterial associated or derived dermatological diseases. The Phase I program has demonstrated excellent tolerability of topical formulations and no systemic exposure. Phase II trials are expected to begin in 2010.

Regulatory Stage

BC-7013 is currently undergoing Phase I clinical trials.