Nabriva Therapeutics (NBRV) is a clinical-stage biopharma that is rallying big this morning (+83%) on some positive news on the clinical front with respect to its LEAP 1 trial to treat community-acquired bacterial pneumonia (CABP).
In terms of quick background, Nabriva is a biopharma focused on developing new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Its medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations.
Nabriva's lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva believes lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP.
Turning to today's news, Nabriva announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1) trial, which evaluated the safety and efficacy of intravenous (IV) to oral lefamulin in patients with community-acquired bacterial pneumonia (CABP). CABP is the leading cause of infectious death in the US. It's a common and potentially life-threatening illness for which presently available antimicrobials have potential limitations.
In the LEAP 1 trial, Nabriva's first of two pivotal Phase 3 clinical trials of lefamulin in patients with CABP, lefamulin met the FDA primary endpoint of non-inferiority (NI, 12.5% margin) compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. In the trial, ECR rates were 87.3% for lefamulin and 90.2% for moxifloxacin.
The company believes that these Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen. The company believes that lefamulin is well suited to be a first-line empiric monotherapy. Lefamulin has the potential to be the first in a new class of antibiotics for CABP in more than 15 years. Nabriva is also conducting a second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in 4Q17 and topline results anticipated in the spring of 2018.
In sum, investors are clearly pleased with today's news as you can see in the stock reaction. The stock had been trending lower over the past couple of months so this was some welcome news to get the stock moving higher. Looking ahead, Nabriva intends to further pursue development of lefamulin for additional indications, including acute bacterial skin and skin structure infections (ABSSSI), and it's developing a formulation of lefamulin appropriate for pediatric use.