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Nabriva Therapeutics (NASDAQ: 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 (OTC: 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.
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