TAIPEI, Taiwan--(BUSINESS WIRE)--TaiGen Biotechnology Co., Ltd. announced today that the nemonoxacin phase II top-line data in community-acquired pneumonia (CAP) met the primary endpoint of non-inferiority versus levofloxacin, the leading quinolone on the market. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Importantly, nemonoxacin possesses the first-in-class activity against MRSA (both hospital- and community-acquired) and vancomycin-resistant pathogens.
The multinational Phase II clinical trial, with an enrollment of 265 patients in three arms, showed nemonoxacin 750 mg once daily in an oral dose over a period of seven days achieved non-inferiority in clinical cure rate of CAP compared with levofloxacin 500 mg once daily in this double-blinded study.
Overall, 82.6% of the intent-to-treat population and 90% of the evaluable population were cured with nemonoxacin compared with 80.0% and 91% cure rate in the levofloxacin arm.
Nemonoxacin demonstrated safety results that were similar to those seen with levofloxacin and were consistent with the favorable safety profile observed with nemonoxacin in earlier phase 1a and phase 1b trials.
“We are very encouraged by this top-line data of the first phase II study of nemonoxacin. With the superior activity against MRSA and vancomycin-resistant pathogens coupled with the cure rate and safety profile seen in CAP patients, this novel antibacterial has the potential to become the first and best in the quinolone class. TaiGen’s second phase II trial in diabetes-foot infection is designed to demonstrate nemonoxacin’s anti-MRSA activity with oral dosing. A once-a-day IV dosing is scheduled to enter clinical trial 2Q 2008,” commented Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.
About TaiGen Biotechnology Co., LTD
TaiGen Biotechnology (www.taigenbiotech.com) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. The company’s in-house R&D has developed first-in-class drug candidates and the first such drug, TG-0054, is currently in phase 1 trial in the US. TaiGen plans to develop TG-0054 for stem cell transplantation, critical limb ischemia and age-related macular degeneration. TaiGen in-licensed nemonoxacin from P&G Pharmaceuticals. P&G and TaiGen are seeking nemonoxacin licensees or co-development partners for the US, EU and Japan market. TaiGen has advanced programs in preclinical development for chronic hepatitis C infection (target at the viral protease) and solid tumors.
TaiGen Biotechnology Co., LTD
Gloria Hsieh, Ph.D., +886-2-2790-1861 ext. 1722
Director, Public Relation & Business Development
Source: TaiGen Biotechnology Co., LTD