USP: 1. Unique structural features endowed nafithromycin are Binding to two sites on 23S rRNA of bacterial ribosomes that fully overcomes azithromycin and clarithromycin resistance Potent in vitro activity based on dual mechanism of action coupled with bactericidal property and longer post-antibiotic effect Higher oral absorption Best-in-class lung penetration site-of-infection along with high alveolar macrophage & PMN concentrations Sustained, therapeutically relevant levels in the lungs even up to 48 hours after the last dose Favourable anti-inflammatory effects Lack of QT prolongation Hepato-safe Devoid of significant CYP inhibition or induction potential No drug-drug interactions Suitable for all age groups 2.Nafithromycin has undergone a rigorous non-clinical and clinical Phase 1, 2 and 3 development for which studies were conducted in US, EU and India, spanned over 12 years. As India marks the macrolide resistance of 60 among pneumococcal isolates ICMR 2023 data , there is an urge for safer and effective CABP treatment for Indian patients. Nafithromycin, with its superior safety & potent antibacterial activity would successfully address this AMR challenge in India.
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