Wockhardt hits all-time high on CDSCO approval for antibiotic Zaynich

The buying on the counter came after the company received approval from the CDSCO for the import and marketing of Zaynich Zidebactam/Cefepime

Wockhardt shares jumped 18.1 per cent on BSE, logging an all-time high of ₹2,092.6 per share. The buying on the counter came after the company received approval from the Central Drugs Standard Control Organisation (CDSCO) for the import and marketing of Zaynich (Zidebactam/Cefepime), an indigenously discovered and developed first-in-class antibiotic, in India. 

However, at 12:34 PM, Wockhardt’s share price pared some gains and was up 17.54 per cent at ₹2082.4 per share. In comparison, BSE Sensex was down 0.10 per cent at 75,792.51. 

The approval covers the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteraemia. 

 

Zaynich is positioned as a potential life-saving therapeutic option in carbapenem-resistant infections, where current treatment options such as colistin and polymyxins are limited by significant toxicity and suboptimal efficacy. The drug is uniquely designed to address metallo-β-lactamase (MBL)-mediated resistance, one of the most prevalent and challenging resistance mechanisms in India.  READ | Larsen & Toubro gains 2%, stock up for sixth straight day; here's why 

The approval is supported by results from the ENHANCE-1 study, a multinational, randomised, double-blind Phase 3 clinical trial evaluating the efficacy and safety of Zaynich compared with meropenem in cUTI patients. Zaynich demonstrated statistical superiority over meropenem for the primary composite endpoint of clinical cure and microbiological eradication at the test-of-cure visit — achieved in 89 per cent of patients treated with Zaynich against 68.4 per cent in the meropenem arm, a treatment difference of 20.6 per cent in favour of Zaynich. 

Among patients with concurrent bacteraemia at baseline, composite response rates were 89 per cent in the Zaynich arm versus 44 per cent in the meropenem arm — underscoring its potential in severe and high-risk infections.  READ | Delta Corp share price tanks 18% today; what's behind the selloff? 

Prior to the Phase 3 programme, Zaynich was evaluated across nine Phase 1 studies and a Phase 2 clinical study involving patients with documented meropenem-resistant Gram-negative infections. The Phase 2 study, conducted across 15 leading tertiary care hospitals in India, demonstrated over 97 per cent clinical efficacy across serious infections, including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bloodstream infections, complicated intra-abdominal infections, and cUTI. 

The Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential to cover extensively drug-resistant Gram-negative pathogens in critically ill patients.