Wockhardt's Miqnaf® pivotal study published in The Lancet

Wockhardt Limited announced the publication of the pivotal Phase 3 clinical study results for its antibiotic, Miqnaf® (nafithromycin), in The Lancet Regional Health Southeast Asia. This marks the first time a novel drug discovered and developed in India has been published in a Lancet journal. The study focused on Miqnaf® for the treatment of community-acquired bacterial pneumonia (CABP).

The Phase 3 study, involving nearly 500 patients, demonstrated Miqnaf®'s non-inferior efficacy compared to moxifloxacin, with clinical improvement in over 90% of patients within 3-4 days. Miqnaf® is the first new macrolide antibiotic in over three decades, designed for once-daily, three-day oral treatment. This is Wockhardt's third novel antibiotic successfully developed and launched from its antibiotic discovery program.

Miqnaf® has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA, underscoring its potential to address antimicrobial resistance and reduce hospitalization burdens related to CABP. Wockhardt maintains a strong pipeline of six antibiotics with QIDP designation, three of which are approved for clinical use.