Nabriva Therapeutics PLC (NASDAQ: NBRV) watched its shares more than double to kick off the week after the firm announced results from its late-stage trial in patients with community-acquired bacterial pneumonia (CABP). The study effectively evaluated safety and efficacy in this LEAP 1 trial of intravenous (IV) to oral lefamulin in patients with CABP.
CABP is a common and potentially life-threatening illness for which presently available recommended antimicrobials have potential limitations often associated with resistance or safety. It’s worth pointing out that CABP is the leading cause of infectious death in the United States.
Ultimately, the trial found that lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint. Not to mention, these results also met the primary endpoints for the European Medicines Agency (EMA) as well.
Management is continuing to execute on its second late-stage trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017. At this rate, top-line results are anticipated in the spring of 2018.
Dr. Colin Broom, CEO of Nabriva, commented:
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. Due to lefamulin’s flexible dosing and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy. I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone.
Excluding Monday’s move, Nabriva has outperformed the broad markets, with the stock up 15% year to date. Over the past 52 weeks, the stock is actually down 11.5%.
Shares of Nabriva closed Friday down 19% at $6.86, with a consensus analyst price target of $17.00 and a 52-week range of $3.52 to $12.75. Following the release of the results, the stock was up about 104% at $13.99 in early trading indications Monday.