Wockhardt Ltd’s shares were up by 16.18 per cent after the company concluded the pivotal phase 3 pneumonia study of its macrolide antibiotic, Nafithromycin WCK 4873. The study compared Nafithromycin to the last-line respiratory antibiotic, Moxifloxacin, demonstrating that a three-day treatment with Nafithromycin is as effective as a seven-day therapy with Moxifloxacin.
Findings from the phase 3 study align with earlier phase 2 research conducted in the US and Europe. A human lung penetration study revealed that Nafithromycin maintains significantly high lung concentrations for up to five days after just three days of dosing. Moreover, it displayed eight times higher lung exposure than Azithromycin and exhibited increased potency against certain respiratory pathogens by 10-100 times.
During the phase 3 study, the three-day treatment with Nafithromycin resulted in a 96.7 per cent clinical cure rate, slightly surpassing the 94.5 per cent clinical cure rate in the Moxifloxacin arm. Notably, Nafithromycin displayed efficacy against various respiratory pathogens, including those resistant to other antibiotics, such as Azithromycin, Amoxycillin+clavulanic acid, and Levofloxacin.
Importantly, the study underscores Nafithromycin as the first macrolide antibiotic in 30 years to complete clinical development for community-acquired bacterial pneumonia. This achievement holds significance, given the stagnation in new macrolide antibiotic approvals since the late 1980s despite pneumonia causing about 2.5 million deaths annually worldwide.
The shares were up by 16.18 per cent to ₹390.20 at 12:33 pm on the BSE.