On Monday, shares of biopharmaceutical company Nabriva Therapeutics (NBRV - Free Report) are surging, up over about 32% in morning trading—the stock skyrocketed 102% in premarket trade—after it announced positive late-stage trial results from its pneumonia treatment, lefamulin.
Lefamulin is used to treat community-acquired bacterial pneumonia (CABP), which is one of the leading causes of infectious deaths in the United States. It’s also the most common type of pneumonia, and occurs outside of hospitals or other health care facilities.
"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," said Nabriva Chief Executive Dr. Colin Broom in a statement.
Headquartered in Dublin, Ireland, Nabriva said that lefamulin met its primary endpoint, as well as primary endpoints for the European Medicines Agency. This is key, since the EMA’s endpoints are based on an assessment that is also a vital secondary endpoint for the FDA, notes MarketWatch.
Additionally, lefamulin was considered to be as effective in treating CABP as current “gold standard” antibiotics, with an early clinical response of 87.3% for intravenous-to-oral lefamulin compared to 90.2% for other treatments.
Nabriva is currently finishing up a second phase 3 trial of lefamulin, and expects to have topline data by next spring.
Today’s announcement comes just two weeks after Nabriva’s chief medical officer Elyse Seltzer resigned, and many analysts feared that that decision would impact lefamulin’s Phase 3 trial results. Seltzer will continue to operate in a consulting role through the first quarter of 2018.
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