The study was conducted at 23 centers in the US and compared two doses of BC-3781 with Vancomycin in 207 patients with ABSSSI.
In the study, BC-3781 demonstrated similar efficacy as Vancomycin, using both the traditional Test of Cure and newer early endpoints, and was safe and well tolerated.
According to Nabriva, BC-3781 showed safety profile and was well tolerated.
No drug related serious adverse events (SAE) were recorded for BC-3781 in any arm.
Nabriva is now planning to conduct Phase III studies using both oral and intravenous administration in two indications: ABSSSI and hospital treated community-acquired pneumonia (HCAP)
Nabriva CMO William Prince said the results are excellent; especially considering this study is the first to treat patients with a pleuromutilin administered intravenously.
"The results confirm the efficacy of BC-3781 in skin infections. It is also significant that BC-3781 was well tolerated and that there was no evidence of clinical safety concerns since one of the persistent barriers to the development of new classes of antibiotics has been the issue of patient safety," Prince said.