Date: 2011-01-10
Type of information: Initiation of preclinical development
phase: 2
Announcement: completion of patient enrolment
Company: Nabriva Therapeutics (Austria)
Product: BC-3781
Action
mechanism: antibioctic/pleuromulin derivative. 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.
Disease: acute bacterial skin and skin structure infections (ABSSSI)
Therapeutic area: Infectious diseases
Country: USA
Trial
details: 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.
Latest
news: Nabriva Therapeutics, a biotechnology company focused on developing a new class of antibiotics for serious infections caused by resistant pathogens, has completed recruitment of a Phase II clinical trial of BC-3781 in acute bacterial skin and skin structure infections (ABSSSI). BC-3781 has now been tested in 10 clinical trials involving over 370 subjects/patients in both oral and intravenous dose forms.
