Should Nabriva Be Seeing a Better Response for This Positive Trial?

Print Email

Nabriva Therapeutics PLC (NASDAQ: NBRV) watched its shares take a step back on Monday’s despite seeing positive results in its late-stage pneumonia trial. The stock was actually up about 17% before the markets opened, but this quickly reversed. The results come from the firm’s lefamulin evaluation against pneumonia (LEAP 2) Phase 3 clinical trial.

In the trial, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to moxifloxacin for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat patient population. ECR was 90.8% for the five-day treatment course of lefamulin and 90.8% for the seven-day treatment course of moxifloxacin.

Lefamulin also met the European Medicines Agency (EMA) primary endpoint for non-inferiority compared to moxifloxacin. This was based on an investigator assessment of clinical response five to 10 days following the completion of study drug dosing.

The rate of treatment-emergent adverse events was 32.6% in the lefamulin arm and 25.0% in the moxifloxacin arm. Serious treatment-emergent adverse events occurred in 4.6% of lefamulin-treated patients and 4.9% of moxifloxacin-treated patients.

Dr. Jennifer Schranz, chief medical officer of Nabriva, commented:

Today marks an exciting advance in the treatment of CABP as we are one step closer to potentially making a much-needed new class of antibiotics available to patients and health care providers. Lefamulin has the potential to be the first-in-class pleuromutilin antibiotic available for IV or oral administration, and results from LEAP 2 provide additional evidence of its efficacy and tolerability in the treatment of adult patients with CABP. We believe lefamulin is well-suited for the empiric treatment of CABP given its short-course regimen, novel mechanism of action, targeted spectrum of activity against the most common and problematic CABP pathogens, and its safety and tolerability profile. I speak for the entire Nabriva team in acknowledging the participation of the patients, their families, investigators, and research organizations who contributed to the successful completion of this clinical trial.

Shares of Nabriva were last seen down 9.7% to $4.90 on Monday. The 52-week trading range is $4.39 to $14.10.