Nabriva Therapeutics ($NBRV) has initiated the second of two pivotal Phase III trials of its antibiotic lefamulin. The latest study will administer an oral form of the antibiotic to people with moderately-severe forms of community-acquired bacterial pneumonia (CABP), a protocol Nabriva thinks will deliver data that complement the results of its other Phase III trial.
In kicking off the second Phase III trial, Nabriva has positioned itself to meet the drug development timeline it committed to when it listed on Nasdaq in September. The IPO, which added $92 million (€83 million) to a bank account that was boosted earlier in the year by a $120 million VC round, set Nabriva up to get both trials underway by the first half of 2016. Having met that deadline, Nabriva is aiming to have data from both studies in the back half of next year, a timeline that would lead to the filing of marketing applications of 2018.
The second trial meets FDA’s demands for two studies, while also broadening the range of patients on whom Nabriva has data. “This complements the first study, in that the first study was targeted to the sicker patients who will need intravenous therapy before switching to oral,” Nabriva CEO Colin Broom told FierceBiotech. “The second study will take care of patients with moderately-severe pneumonia, so that means that we will have data in the broad spectrum, from the relatively-mild patients to the ones who are really exceedingly sick and probably in the intensive care.”
If lefamulin comes to market, Nabriva will initially focus on sicker patients, a strategy that reflects the likely reticence to prescribe a novel antibiotic as anything other than a last resort. “Quite frankly, your GP is not going to prescribe a brand new antibiotic with a new mechanism of action until there's more experience around it,” Broom said. “As clinicians get more experience with treating the sicker patients ... they'll gradually start using it more in the community. That's probably a process that takes a few years.”
One consequence of the forecast gradual broadening of the use of the antibiotic is that Nabriva feels capable of commercializing it itself in the U.S.. Outside of the U.S., Nabriva, which is headquartered in Vienna, Austria but has operations in King of Prussia, PA, is looking for partnerships. Broom is not ruling out striking deals before the readouts from the Phase III trials.
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