Shares of Wockhardt gained around 3% after the company announced that its novel antibiotic, Zaynich® (Zidebactam/Cefepime), received a favourable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization.
The recommendation marks an important regulatory step, as the proposal will now be reviewed by the Drugs Controller General of India for final marketing approval in India.
The SEC’s positive opinion follows an extensive evaluation of clinical and non-clinical data submitted by the company. The dossier included nine Phase 1 studies, a Phase 2 study focused on meropenem-resistant infections, and a global Phase 3 trial targeting complicated urinary tract infections and acute pyelonephritis. Data from 85 compassionate-use cases across multiple countries was also part of the review.
Zaynich® has been developed over a period of 15 years by a multidisciplinary team of scientists. The drug uses a β-lactam enhancer-based mechanism aimed at addressing infections caused by multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens.
The clinical development programme included Phase 1 studies conducted in the United States and China involving nearly 300 participants. This was followed by a global Phase 3 trial with 530 patients across 64 sites spanning the United States, Europe, Latin America, China, and India.
According to the company’s submitted data, the Phase 3 study demonstrated improved combined clinical and microbiological cure rates compared to meropenem in the targeted indications. Additional studies conducted in India reported clinical efficacy in treating resistant infections across hospital settings, including pneumonia, bloodstream infections, and intra-abdominal infections.
Zaynich® has also been used in 85 compassionate-use cases involving XDR Gram-negative infections across India, the United States, Malaysia, and France, where treatment options were limited.
The Clinical and Laboratory Standards Institute has assigned an investigational susceptible breakpoint of 64 mg/L for the drug combination, indicating its potential coverage against resistant pathogens in critical care settings.
Separately, regulatory filings for Zidebactam/Cefepime are progressing in key international markets. A New Drug Application (NDA) has been submitted in the United States, while a Marketing Authorisation Application (MAA) is under review in the European Union.