Nabriva's Stock Explodes as Pneumonia Drug Wows in Two Phase III Trials

September 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff

DUBLIN – Shares of Nabriva Therapeutics are skyrocketing this morning after the company’s experimental antibiotic to treat community-acquired bacterial pneumonia (CABP) met trial endpoints in a key Phase III trial.

According to a company analysis, there are approximately 5 million adults treated annually for CABP in the United States. That could be one reason shares have rocketed up more than 87 percent this morning, hitting a high of $13.35 as of 9:35 a.m.

Nabriva said its antibiotic lefamulin met the primary endpoint of non-inferiority compared to moxifloxacin with or without adjunctive linezolid for early clinical response in the first of two Phase III trials. The company, which has U.S. offices outside of Philadelphia, said early clinical response rates for intravenous to oral lefamulin doses were 87.3 percent compared to 90.2 percent for moxifloxacin with or without linezolid. That is a, a treatment difference of -2.9. Additionally the company said lefamulin met the primary non-inferiority endpoints called for by the European Medicines Agency.

Not only does the data show the drug to be as effective as standard of care treatment, the trial data also showed a strong safety profile for the drug.

Colin Broom, chief executive officer of Nabriva Therapeutics, said the data provides strong evidence that its lefamulin regimen could be an alternative to “a current gold standard treatment option.”

“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,” Broom said in a statement.

Lefamulin is designed to target common CABP bacteria by stopping their ability to replicate. Drug developers also see lefamulin as a potential treatment that can combat the growing problem of resistant bacteria in CABP.

Nabriva is initiating a second Phase III evaluating oral lefamulin for the treatment of CABP. The company anticipates top-line results in the spring of 2018.

The positive results for Nabriva comes hard on the heels of the resignation of the company’s chief medical officer. On Sept. 1, Elyse Seltzer announced she intended to resign her position and would remain with the company through the end of September. No reason was provided for her departure, other than to say she planned to pursue “other professional endeavors.” Seltzer will remain as a consultant to the company through the end of the first quarter of 2018. Broom is now serving as the interim chief medical officer in addition to his CEO duties.

Leerink analyst Paul Matteis was also pleased with the trial results. In a note published on Endpoints News he said the data presented by the company should indicate a likely clear path to approval from the U.S. Food and Drug Administration.

If approved, lefamulin would be the first in a new class of antibiotics for CABP in more than 15 years, Broom added.