Two weeks after its chief medical officer resigned, sparking jitters among the more hopeful analysts following the company, Nabriva Therapeutics $NBRV announced that its key Phase III study for the antibiotic lefamulin hit the primary endpoint in proving non-inferior to moxifloxacin for community-acquired pneumonia.
The scheduled departure of CMO Elyse Seltzer at the end of this month created some uncertainty among the analysts like Leerink’s Paul Matteis, who had credited Nabriva — a Novartis spinout helmed by Colin Broom — with a 60% shot at success in this first-of-two Phase III studies, dubbed LEAP I. Those fears proved unfounded, which ignited a big rally for its shares. Nabriva’s stock soared 100% in pre-market trading today.
Researchers tracked an 87.3% early clinical response rate for IV-to-oral lefamulin compared to 90.2% for moxifloxacin with or without linezolid. And switching to a modified intent to treat standard, the biotech also laid claim to hitting the primary needed for the EMA.
In addition, the safety profile looked good in comparison, with a significantly lower rate of diarrhea in the new antibiotic group.
Leerink’s Paul Matteis offered a quick thumbs up:
IV-to-oral lefamulin demonstrated non-inferiority to moxifloxicin with or without linezolid, while a considerable amount of disclosure on safety/tolerability in the press release suggests a fairly clean – and likely approvable – profile, in our view.
LEAP II is expected to read out top-line oral data in early 2018, which Nabriva is hoping will set up applications with the key agencies.
The biotech’s shares started the day trading at a little more than half its 2017 high, set in early March. The stock nose dived abruptly Friday afternoon by close to 20%, with no news in advance of the top-line readout.
Nabriva pulled off a downsized IPO with $92 million about two years ago, which followed a $120 million venture round led by Vivo Capital and OrbiMed that centered on its lead antibiotic.
“These Phase III 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 Broom in a statement. “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. We continue to execute on our second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017 and topline results anticipated in the spring of 2018.”
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