Wockhardt upbeat on Phase III pneumonia study results involving antibiotic candidate

Drugmaker Wockhardt has completed its Phase III pneumonia study on antibiotic candidate Nafithromycin WCK 4873, said the company.

Nafithromycin (WCK 4873) was comparatively evaluated in a multi-centre double blind Phase III pneumonia study against the last-line respiratory antibiotic Moxifloxacin, said Wockhardt. The results revealed that “an ultrashort course of three-day treatment with Nafithromycin is as effective as seven-day therapy with Moxifloxcain,”, said the company.

Wockhardt shares shot up on the news, at ₹386.10, up over 14 cent on the BSE. Monday (14.02 pm). The findings with Nafithromycin are a major advancement in 30 years for treatment of pneumonia, making it an effective and safe option for community usage for resistant organisms, according Wockhardt.

The Phase III findings were in line with the Phase II study conducted in the US and Europe. A human lung penetration study conducted in the US revealed that Nafithromycin possessed “a remarkable feature of sustained high lung concentration built-up over five days following just three days of dosing”, said the company, adding that the “human lung exposure of Nafithromycin is eight times higher than Azithromycin and potency being 10-100 times higher for certain respiratory pathogens”.

In the Phase III study, three-day treatment with Nafithromycin resulted in clinical cure for 96.7 per cent of patients, against 94.5 per cent in the Moxifloxacin arm, said Wockhardt. “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”, it added.

“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 drugmaker claimed.

macrolide antibiotics

The study establishes that Nafithromycin represents a first-ever macrolide (used to treat bacterial infections) in 30 years, which has successfully completed clinical development for the indication of community acquired bacterial pneumonia, said the company. The currently available macrolide antibiotics — Azithromycin and Clarithromycin — were approved in 1988 and 1991, respectively. Since then no new macrolide antibiotics have been approved despite pneumonia causing about 2.5 million deaths annually worldwide, according to the World Health Organization.

According to Indian Council of Medical Research (ICMR) surveillance data, 65 per cent resistance to Erythromycin in Indian pneumococcal isolates and globally up to 40 per cent resistance to Azithromycin. “China has alarmingly high incidence of over 80 per cent resistance to Azithromycin among pneumococci,” said the company. Citing the infectious disease related mortality burden reported in the medical journal Lancet, the note said, deaths estimated to have taken place in India due to pneumococcal infection amounted to 151,768.