THE LANCET Regional Health publishes Pivotal Phase 3 Clinical Study on Miqnaf®

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.

Robust Phase 3 Evidence

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).

Global Recognition and Clinical Impact

The Lancet Regional Health publication delivers a scientifically robust resource for clinicians worldwide, highlighting Miqnaf®'s potential to:

- Reduce CABP-related hospitalization burden
- Address antimicrobial resistance (AMR) through a dual mechanism of action
- Enable shorter, more effective treatment courses

With its convenient dosing and proven clinical outcomes, Miqnaf® represents an important advancement in the global fight against AMR.

A Milestone for Indian Drug Discovery

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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Keywords

Wockhardt INE049B01025 Pharmaceuticals THELANCET RegionalHealth Phase3 ClinicalStudy Miqnaf nafithromycin