Nov 6, 2017
TaiGen's Intravenous Taigexyn Successfully Completed Phase 3 Clinical Trial for Community Acquired Pneumonia in Taiwan
TaiGen's Intravenous Taigexyn(R) Successfully Completed Phase 3 Clinical Trial for Community Acquired Pneumonia in Taiwan
TAIPEI, Taiwan, Nov 6, 2017 – TaiGen Biotechnology Company, Limited ("TaiGen") today announced that it has completed the Phase 3 clinical trial (TG-873870-C-6) of the intravenous formulation of Taigexyn® (Nemonoxacin) in Taiwan. The Phase 3 trial is a randomized, double-blinded, and multicenter study comparing intravenous formulations of Taigexyn® 500 mg vs. levofloxacin 500 mg in patients with moderate to severe community-acquired pneumonia. Statistical analysis showed that the co-primary endpoint of this Phase 3 study (clinical success rate at Visit 4 in both ITT* (intent-to-treat) and CE^ (clinical evaluable) population) was achieved. In the ITT population, the clinical success rates for nemonoxacin 500 mg and levofloxacin 500 mg were 81.1% and 80.5%, respectively (treatment difference: 0.6%; 95% CI: -6.4% and 7.6%). In the CE population, the clinical success rates for nemonoxacin 500 mg and levofloxacin 500 mg were 95.4% and 88.3%, respectively (treatment difference: 7.0%; 95% CI: 0.7% and 13.3%). Nemonoxacin 500 mg was shown to be non-inferior to levofloxacin 500 mg in that the lower limits of the 95% CI of the treatment differences were all greater than ‒10% for both ITT and CE population.
This Phase 3 enrolled a total of 598 patients, 80 patients from 16 sites in Taiwan and 518 patients from 43 sites in mainland China. With the successful completion of Phase 3, TaiGen will prepare for the filing of New Drug Application (NDA) of the intravenous formulation of Taigexyn® with Taiwan FDA in 2018.
*ITT, all randomized patients who received study drug.
^CE, all ITT patients who met the minimal disease criteria, had efficacy evaluation, and subsequently adhered to the protocol without major protocol violations.
About Taigexyn®
Taigexyn® is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria. It is available in both oral and intravenous formulations. The oral formulation is approved and launched in Taiwan and mainland China. The NDA for the intravenous formulation of Taigexyn® has already been filed in with China FDA in May 2017. Taigexyn® is partnered in Russia, Commonwealth Independent States, Turkey, Mexico, Brazil and the Latin American territory for a total of 32 countries worldwide.