Wockhardt announced that the full results of the Phase 3 clinical study of Miqnaf® (nafithromycin), a novel antibiotic, have been published in THE LANCET Regional Health Southeast Asia. The study highlights the drug’s potential in combating community-acquired bacterial pneumonia (CABP) and addressing antimicrobial resistance, representing a significant advancement in antibiotic innovation. Clinical improvement was observed in >90% of patients.
Landmark Antibiotic Publication
THE LANCET Regional Health Southeast Asia has published the pivotal Phase 3 clinical study results for Miqnaf® (nafithromycin), Wockhardt’s novel antibiotic for community-acquired bacterial pneumonia (CABP). This marks the first publication in a LANCET journal for an India-developed novel drug.
Miqnaf® Clinical Study Details
The Phase 3 study compared Miqnaf® with moxifloxacin in nearly 500 patients. The trial demonstrated Miqnaf®’s non-inferior efficacy, with clinical improvement observed in >90% of patients within 3-4 days of treatment. The study supports Miqnaf® as a valuable alternative for treating CABP, including infections caused by macrolide-resistant pathogens.
Addressing Antibiotic Resistance
Miqnaf® is designed to tackle the growing challenge of multi-drug resistant CABP, offering a convenient, once-daily, three-day oral treatment regimen. It can potentially reduce CABP-related hospitalization, address antimicrobial resistance (AMR), and enable shorter, more effective treatment courses.
Wockhardt’s Contribution
Miqnaf® is Wockhardt’s third successfully developed and launched novel antibiotic. Wockhardt has a strong pipeline of six antibiotics at various stages of development and commercialization, all granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA.
Source: BSE
