Nabriva Finalizes Recruitment in Phase 2 ABSSSI Trial

Nabriva Therapeutics, a biotechnology company focused on developing a new class of antibiotics for serious infections caused by resistant pathogens, announced that it has completed recruitment of a Phase 2 clinical trial of BC-3781 in acute bacterial skin and skin structure infections (ABSSSI). BC-3781 is a pleuromutilin antibiotic with both oral and intravenous dose forms that is being developed for the treatment of bacterial diseases such as skin and skin structure infections and pneumonia.

210 patients have been recruited from 24 clinical sites in the USA. This Phase II clinical study was a double blind study with two dose regimens of intravenous BC-3781 (100 or 150mg twice daily) versus vancomycin as an active comparator. The primary endpoint of the study was to assess the clinical response to these two dose regimens. Secondary endpoints, in line with the recent FDA guidance on trials of ABSSI, included the cessation of spread of lesions within 48-72 hours and the resolution of fever.

Dr. David Chiswell, CEO of Nabriva Therapeutics commented: “BC-3781 has now been tested in 10 clinical trials involving over 370 subjects/patients in both oral and intravenous dose forms. Assuming the Phase II data is positive this data package should allow us to take BC-3781 forward into an extensive Phase 3 program.”

Dr. William Prince, CMO of Nabriva Therapeutics added: “In designing this trial we included the endpoints proposed in the recent draft FDA guidance on developing drugs for the treatment of ABSSI. We expect to have top line data available during the first quarter of 2011. The ultimate intention is to seek FDA and EMA approval for the treatment of bacterial skin and lung infections as well as other indications offering both intravenous and oral formulations of BC-3781.”

BC-3781 is highly active against key pathogens, including MRSA, associated with skin infections and community and hospital acquired pneumonia. The compound’s novel mode of action ensures that it overcomes antibiotic resistance developed due to the use of all approved classes of antibiotics. BC-3781 is the first pleuromutilin antibiotic to be developed for both oral and intravenous use in humans.

Date: January 10, 2011
Source: Nabriva Therapeutics