Drugmaker Wockhardt seems poised to unveil a “promising antibiotic” to treat pneumonia, Nafithromycin WCK 4873. And the development comes at a time, the global medical community grapples with anti-microbial resistance (AMR).

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

The Nafithromycin findings are a major advancement in 30 years of pneumonia treatment, making it an effective and safe option to use in the community, against resistant organisms, said Wockhardt.

The company will apply for regulatory approvals in India shortly, and expects to launch by mid-2024. It has an existing licensing deal with Jemincare, China for development and commercialization in Greater China, according data shared with investors.

Trial findings

The Phase III findings were in line with the Phase II study conducted in the United States and Europe, the company said. 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,” the company said, adding that the “Human Lung exposure of Nafithromycin is 8 times higher than Azithromycin and potency being 10-100 times higher for certain respiratory pathogens.”

The study also revealed, the three-day treatment with Nafithromycin resulted in clinical cure for 96.7 percent of patients as against clinical cure rate of 94.5 percent in the Moxifloxacin arm, Wockhardt said. “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 added.

30 years on

The study establishes that Nafithromycin represents a first ever macrolide (used to treat bacterial infections) in 30 years that has successfully completed clinical development to treat community acquired bacterial pneumonia, Wockhardt said. 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, it added.

Dr Abdul Ghafur, Infectious Diseases consultant with Apollo Hospitals, said, the antibiotic was “promising”, going by data publicly communicated by the company. The drug comes when the “antibiotic pipeline is dry and AMR is a concern globally,” he added. The development reflected capabilities of Indian scientists, Ghafur told businessline, pointing to another promising antibiotic candidate also from Wockhardt - WCK 5222, that has been given for compassionate use to patients.

Another promising antibiotic is Cefidorocol. from Japanese drugmaker Shionogi, he added. Shionogi has a sublicensing agreement through GARDP (Global Antibiotic Research and Development Partnership), allowing Orchid Pharma to produce it.

According to Indian Council of Medical Research (ICMR) surveillance data, there is 65 per cent resistance to Erythromycin in Indian pneumococcal isolates and globally up to 40 percent resistance to Azithromycin. “China has alarmingly high incidence of over 80% resistance to azithromycin among pneumococci,” the company said. 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.