What happened

Investors in Nabriva Therapeutics (NASDAQ:NBRV) 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.

A group of medical professionals cheering.

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 (NASDAQ:PRTK) 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.

Brian Feroldi has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.