Nabriva Therapeutics today announced the successful results of a Phase II clinical trial of BC-3781 in acute bacterial skin and skin structure infections (ABSSSI). Nabriva's lead product BC-3781 is the first of a new class of systemically available pleuromutilin antibiotics for the treatment of serious skin infections and pneumonia. BC-3781 is being developed for both oral and intravenous formulations.
This double blind, randomized controlled study compared two doses of BC-3781, with Vancomycin, the standard treatment for drug resistant Gram-positive bacterial skin infections, in 207 patients with ABSSSI recruited in 23 centers in the USA. BC-3781 had the same efficacy as Vancomycin, using both the traditional Test of Cure and newer early endpoints, and was safe and well tolerated. The results of this study provide the first proof of concept for the use of a pleuromutilin antibiotic systemically in man.
Dr William Prince CMO commented:
"The results are excellent; especially considering this study is the first to treat patients with a pleuromutilin administered intravenously. The patient population selected for this study was severely ill and each had two signs of systemic disease. 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."
Dr. David Chiswell, CEO Nabriva Therapeutics added:
"These encouraging results are an important milestone for Nabriva and our plans to establish intravenous and orally administered pleuromutilins as a new class of antibiotics. We are now moving forward with plans to conduct phase III studies using both oral and intravenous administration in two indications: ABSSSI and hospital treated community-acquired pneumonia (HCAP)."
Source: Nabriva Therapeutics