Phase III trial of Taigexyn (nemonoxacin) meets endpoint in community acquired pneumonia infection- TaiGen Biotechnology

TaiGen Biotechnology has announced that the intravenous formulation of Taigexyn (nemonoxacin) has achieved the primary endpoint (clinical success rate at Visit 4 in the evaluable-mITT population) in the Phase III clinical trial of community acquired pneumonia (TG-873870-C-6). This trial was a randomized, double-blinded study comparing intravenous formulations of Taigexyn 500mg vs. levofloxacin 500 mg and has recruited 525 patients from Taiwan and mainland China.

The clinical success rates for Taigexyn 500 mg and levofloxacin 500 mg were 92.8% and 87.0%, respectively, in evaluable-mITT subjects. Taigexyn 500 mg was shown to be non-inferior to levofloxacin 500 mg in that the lower limit of the 95% CI of the treatment difference was greater than -10%. Based on these results, TaiGen will prepare for the filing of New Drug Application with China's FDA in 2016.

Comment: TaiGen have completed multiple clinical trials (Phase I-III) for community acquired pneumonia in Taiwan and mainland China and have filed for NDA of the oral formulation in both markets in March and April 2013 respectively. The Taiwan FDA granted new drug license for the oral formulation of Taigexyn to TaiGen in January 2015.