Wockhardt has completed the pivotal Phase 3 pneumonia Study of its macrolide antibiotic Nafithromycin WCK 4873. Wockhardt NCE, WCK 4873 named as Nafithromycin was comparatively evaluated in multi-centre double blind Phase 3 pneumonia study employing the last-line respiratory antibiotic Moxifloxacin. The results of the study showed that an ultrashort course of three-day treatment with Nafithromycin is as effective as seven-day therapy with Moxifloxacin. The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe. A human lung penetration study conducted in the US revealed that Nafithromycin possesses a remarkable feature of sustained high lung concentration built-up over five days following just three days of dosing. Human Lung exposure of Nafithromycin is 8 times higher than Azithromycin and potency being 10-100 times higher for certain respiratory pathogens.
In Phase 3 study, three-day treatment with Nafithromycin resulted in clinical cure for 96.7% of patients as against clinical cure rate of 94.5% in Moxifloxacin arm. The Phase 3 study outcome establishes broad-spectrum efficacy of Nafithromycin against Gram-positive respiratory pathogens, fastidious Gram-negative pathogens as well as therapeutically challenging intracellular atypical pathogens such as Mycoplasma pneumoniae, which were recently implicated for the surge of hospitalisations in China due to pneumonia. A significant proportion of study patients were infected with pathogens showing resistance to Azithromycin, Amoxycillin+clavulanic acid and Levofloxacin. The role of Nafithromycin in managing such patients would be of heightened interest to clinicians.
The Phase 3 study did not encounter any serious Adverse Event (AE), all the reported AEs were mild, and most were considered unrelated to the study drugs by the investigators except for nausea and gastrointestinal effects.
Wockhardt is a research based global pharmaceutical and Biotech Company headquartered in Mumbai, India.
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