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Press Release: TaiGen Announces Nemonoxacin (TG-873870) Once-A-Day Oral Dosing in Diabetic Foot Infection Met Primary Endpoints Promising Anti-MRSA Activity and Excellent Pharmacokinetic Profile Demonstrated in a Phase II Proof of Concept trial
Quote:
TAIPEI, Taiwan, March 12 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. announced today the Phase II trial of nemonoxacin (TG-873870) in Diabetic Foot Infection (DFI) with once-a-day dosing met the primary endpoints and showed promising clinical efficacy and good tolerability. 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 activities against Methicillin-Resistant Staphylococcus aureus (MRSA) and vancomycin-resistant pathogens. This single arm, proof-of-concept study was conducted in US, South Africa, Thailand and Taiwan in mild to moderate DFI patients who were treated with nemonoxacin 750mg once daily for one or two weeks. Nemonoxacin showed higher clinical and microbiology success rates compared with previous DFI trials. Among the 40 enrolled patients, there were four MRSA-infected patients, including one patient with quinolone-resistant MRSA, who were clinically successful treated. Nemonoxacin also demonstrated excellent pharmacokinetic profile in tissue penetration and relatively low drug-drug interactions in this group of patients who received multiple medications concomitantly for other disease conditions.
"In addition to the top-line efficacy and safety data from our early phase 2 Community-Acquired Pneumonia (CAP) trial, we are very encouraged by the DFI data. With the clinically proven superior anti-MRSA activity and efficacy in DFI patients - a very difficult-to-treat patient population, we believe nemonoxacin is not only the best in class quinolone drug, but also the first in class anti-MRSA quinolone drug with excellent safety profile. Increasing prevalence of Community-acquired MRSA infection has become a highly unmet medical need with limited alternative treatment options. Nemonoxacin represents a promise to the cure that TaiGen will deliver with great hope," commented Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com/ ) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, China. The company has a full capacity in discovery research and clinical development in China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market. Nemonoxacin, a novel broad-spectrum non-fluorinated quinolone with anti-MRSA activity and in-licensed from P&G Pharmaceuticals, achieved non-inferiority in clinical cure rate and safety profile compared with Levofloxacin in its Phase II CAP trial. TaiGen is seeking Nemonoxacin licensees for the US, EU and Japan markets.
Nemonoxacin for diabetic foot infections
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