Nabriva Therapeutics, a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, and Roivant Sciences, announced the initiation of a collaboration to develop and commercialize lefamulin.
Lefamulin has completed a pivotal, international Phase 3 clinical trial for the treatment of adults with moderate to severe community-acquired bacterial pneumonia (CABP). Topline data from a second pivotal, international Phase 3 clinical trial are expected in the spring of 2018.
As part of the license agreement, Nabriva has granted a Roivant subsidiary an exclusive license to develop and commercialize lefamulin in the greater China region, specifically the People’s Republic of China, Hong Kong, Macau, and Taiwan. The companies will establish a joint development committee to review and oversee all development and commercialization plans.
Lefamulin is a semi-synthetic derivative of pleuromutilin that inhibits a key process for bacterial growth. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP. Furthermore, if approved, the availability of both oral and intravenous (IV) formulations and a favorable tolerability profile make it appropriate for potential use across all three CABP treatment settings, including in-hospital, transition of care, and community-initiated.