H.C. Wainwright initiated coverage of Nabriva Therapeutics (NASDAQ:NBRV) with a “buy” rating and $16 price target. The stock closed at $7.92 on Wednesday.
Originally spun-off from Sandoz, Austria-based Nabriva has in-house expertise and broad, wholly-owned IP protection in the development of a novel pleuromutilin class of antibiotics.
Analyst Ed Arce writes that lead compound, lefamulin, is a semi-synthetic small molecule with potent activity against an extended spectrum of key respiratory pathogens, including multi-drug resistant strains such as MRSA, which “we view as a profile close to ideal for the treatment of moderate-to-severe community-acquired bacterial pneumonia (CABP) in the hospital.”
In addition, with a lack of cross-resistance observed with other antibiotic classes, and mutations required at four distinct sites of the ribosome, he said the development of bacterial resistance to lefamulin is expected to take significantly longer, compared with other antibiotics.
In a prior Phase 2 study in acute bacterial skin and skin structure infections, lefamulin demonstrated a superior safety and tolerability profile to some other antibiotics
“However, despite the thorough in vitro data in CABP and the supportive translational data, we acknowledge that some investors may find reason for pause, given that no clinical trials of lefamulin in CABP patients have been conducted prior to the current, ongoing Phase 3 studies,” he added.
“Yet, we view key pre-clinical data (time-dependent killing via 24-hour AUC/MIC model, and substantial lung penetration and epithelial lining fluid concentrations in animal and human studies) as strongly predictive of efficacy and supportive of pivotal testing.”
Readouts of both Phase 3 studies are expected in the second half of 2017.