Nabriva Therapeutics Stock Gains On Positive Lefamulin Data In CABP Patients In China

Nabriva Therapeutics NBRV and its collaborating partner in China, Sinovant Sciences, have announced positive topline results from Sinovant's Phase 3 bridging study evaluating lefamulin in Chinese adults with community-acquired bacterial pneumonia (CABP).
Lefamulin met the primary endpoint of non-inferiority versus moxifloxacin, a broad-spectrum antibiotic for Investigator Assessment of Clinical Response at Test of Cure (IACR-TOC).
IACR-TOC is defined as the resolution or improvement of a subject's clinical signs and symptoms without any additional antibacterial therapy.
Success rates of 76.8% (n = 63/82) for lefamulin and 71.4% (n = 30/42) for moxifloxacin was observed.
IACR-TOC in the clinically evaluable population, success rates were 86.0% (n = 49/57) and 86.2% (n = 25/29) in the lefamulin and moxifloxacin arms, respectively.
lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events comparable to that of moxifloxacin.
In addition, Sinovant has entered into an agreement with Sumitomo Pharmaceuticals (Suzhou) Co Ltd, a wholly-owned subsidiary of Sumitomo Dainippon Pharma DNPUF, to acquire development and commercialization rights for lefamulin in Greater China.
Lefamulin (marketed by Nabriva in the U.S. as Xenleta) is a semi-synthetic pleuromutilin antibiotic for systemic administration.
Price Action: NBRV shares are up 60.1% at $2.37 during the premarket session on the last check Wednesday.