THE LANCET Regional Health Southeast Asia, a globally respected and peer-reviewed journal has published the full results of the pivotal Phase 3 clinical study of Miqnaf (nafithromycin) for the treatment of community-acquired bacterial pneumonia (CABP). This marks the first-ever publication in a LANCET journal for a novel drug discovered and developed in India, underlining the global relevance and scientific rigor of this study.
Miqnaf is the first new macrolide antibiotic in over three decades, discovered, developed andlaunched in India, designed to address the growing challenge of multi-drug resistant CABP. It offers a convenient oncedaily, three-day oral treatment regimen, a significant step toward improving compliance, minimizing hospitalization, and enhancing patient outcomes.
This first-of-its-kind Phase 3 study compared Miqnaf® directly with moxifloxacin, a gold-standard CABP drug in terms of efficacy. Conducted in nearly 500 patients, the trial demonstrated Miqnaf®'s non-inferior efficacy, with clinical improvement observed in >90% of patients as little as 3-4 days from treatment initiation. These results provide compelling evidence for Miqnaf® as a valuable alternative in the treatment of CABP, including infections caused by macrolide-resistant pathogens. In India, resistance to macrolides such as azithromycin and clarithromycin has reached alarming levels, approaching nearly 75%, according to the 2023 report by the Indian Council of Medical Research (ICMR).
Miqnaf is the third novel antibiotic successfully developed and launched from Wockhardt's antibiotic discovery program, reinforcing India's growing contribution to global antimicrobial innovation.
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