Indian pharma player Wockhardt Ltd has said that the Phase III clinical trial for Zaynich (Zidebactam/Cefepime) is making progress according to the schedule and is likely to complete by the first quarter of 2025.
Zidebactam/Cefepime, an investigational antibiotic categorised under the novel class of 'β-lactam enhancers', is under evaluation for its efficacy in treating complicated urinary tract infections, including acute pyelonephritis. The trial, as of May 27, has successfully enrolled 392 patients, the company said in a press statement.
Wockhardt further reported a continued influx of requests for compassionate use of Zidebactam/Cefepime. These requests predominantly aim to address challenging cases such as severe bloodstream infections, bacterial pneumonia associated with hospitalisation and ventilator use, osteomyelitis, and intra-abdominal infections among cancer and transplant patients.
Also read: Wockhardt has more antibiotics in the pipeline: Dr Habil Khorakiwala
So far it has supplied Zidebactam/Cefepime to 30 patients for compassionate use with range of life-threatening infections as described below:
- 11 patients with Hospital/ventilator acquired pneumonia infected with pan-drug resistant pathogens, several of them in septic shock
- 2 patients of serious bloodstream infection in septic shock
- 8 patients of osteomyelitis failed to resolve with any of the available antibiotic options even when treated for longer duration
- 4 patients of complicated urinary tract infection with severe renal impairment.
Wockhardt has announced that its medicine has demonstrated a remarkable 100 percent clinical cure rate among 30 critically ill patients suffering from a variety of life-threatening, extensively drug-resistant Gram-negative infections. These patients faced a challenging array of infections, including hospital-acquired/ventilator-associated pneumonia, empyema, bloodstream infections, urosepsis, intra-abdominal infections, necrotising fasciitis, and osteomyelitis, caused by a spectrum of highly resistant Gram-negative pathogens such as Pseudomonas, Klebsiella, E coli, Acinetobacter, and Serratia.
Some 20 of these patients had previously showed no response to antibiotic combinations like ceftazidime/avibactam + aztreonam + polymyxin B/colistin, while ten had proven resistant to colistin/polymyxin B treatment. Additionally, eight patients were in septic shock before initiating Zidebactam/Cefepime therapy.
Prior to resorting to Zidebactam/Cefepime under compassionate use approval from the Central Drugs Standard Control Organisation (CDSCO), medical practitioners attempted treatment with colistin or polymyxin B, which unfortunately resulted in severe nephrotoxicity and neurotoxicity without resolving the infections.
Administered under compassionate use approval, Zidebactam/Cefepime showed notable efficacy with treatment durations ranging from one to 11 weeks. Patients displayed significant clinical improvement within one-two weeks of initiating therapy, with complete clinical and microbiological resolution observed by the end of treatment. The medication was well-tolerated even during extended treatment durations, essential for stubborn infections such as osteomyelitis.
Zidebactam/Cefepime is undergoing a multinational Phase 3 study, anticipated to streamline its global registration and marketing authorisation. Previous Phase 1 studies, including clinical pharmacology investigations, were conducted in the US.
Wockhardt is a research-based global pharmaceutical and biotech company. Its new drug discovery programme has focussed on unmet need of anti-bacterial drugs that are effective against the menace of untreatable superbugs. Wockhardt is the only company in the world where the US FDA has given QIDP Status (Qualified Infectious Disease Product) in six of its anti-bacterial discovery programmes with three of them Gram-negative and three Gram-positive effective against untreatable 'superbugs'.
Also read: Wockhardt's R&D prowess attracts marquee investors Madhusudan Kela, Prashant Jain
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