What happened
Investors in Nabriva Therapeutics (NBRV +0.00%) are having a wonderful start to the trading week. Shares of the clinical-stage biotech focused on antibiotics rose 36% as of 11:30 a.m. EDT on Monday in response to reporting encouraging data from its phase 3 LEAP 1 trial.
So what
The LEAP 1 trial was designed to study the safety and efficacy of the company's lead compound lefamulin in treating community-acquired bacterial pneumonia (CABP). CABP is leading cause of death from infection in the United States and is a very serious public health issue.
Top-line data from the 551 patient trial showed that lefamulin was able to meet the FDA's and European Medicines Agencies primary endpoints of non-inferiority when compared to moxifloxacin with or without adjunctive linezolid. Specifically, the early clinical response rate assessed for lefamulin was 87.3%, while moxifloxacin's rate was 90.2%. What's more, lefamulin's safety data was also comparable to moxifloxacin.
Dr. Colin Broom, Nabriva's CEO, offered investors the following commentary on the trial:
"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."
Given the clinical results, it is easy to understand why traders are bidding up shares on Monday.
Image source: Getty Images.
Now what
CABP is responsible for more than 3 million hospitalizations each year in the U.S. and has a mortality rate of more than 5%. What's more, the rise of antibiotic-resistant bacteria is exacerbating the need for new and improved treatment options. These facts suggest that lefamulin could quickly become a top seller if it manages to cross the finish line.
However, investors should remember that Nabriva is far from the only company with a dog in this race. Paratek Pharmaceuticals (PRTK +0.00%) is another clinical-stage biotech that is focused on next-generation antibiotics, and just a few months ago the company reported encouraging top-line results from a phase 3 study evaluating its investigational drug omadacycline as a treatment for CABP. The company also reported that it plans to have the drug in regulators hands in early 2018. That represents a faster timeline than Nabriva is currently on with lefamulin so the company's investors should watch omadacycline's progress closely.
Nabriva is moving forward with its LEAP 2 trial, which is the company's second pivotal phase 3 study comparing oral lefamulin to moxifloxacin. Enrollment is expected to be completed in the fourth quarter of this year and top-line data should be available in early 2018. Potential investors might want to wait until data from the LEAP 2 trial becomes available before they decide whether or not to jump in.
