The Indian pharma company, Wockhardt Ltd, on Wednesday, 29 May, said that the Phase III clinical trial for Zaynich (Zidebactam/Cefepime) is expected to be completed by the first quarter of 2025. 

Research is being done to see how well zidebactam/Cefepime, an investigational antibiotic from the novel class of “β-lactam enhancers,” works for treating complex UTIs and acute pyelonephritis. As of 27 May, 392 participants had been successfully registered in the experiment, according to a news statement from the company.

The compassionate use of cefepime/zidebactam is still being requested, Wockhardt added. Most of these requests aim to address challenging cases such severe bloodstream infections, osteomyelitis, bacterial pneumonia associated with hospitalisation and ventilator use, and intra-abdominal infections in cancer and transplant patients.

30 patients have received Zidebactam/Cefepime so far for compassionate use with a range of life-threatening illnesses, as indicated below:

• 11 hospitalised patients, several of whom were in septic shock, with pneumonia and ventilator-associated pan-drug resistance bacteria
• A significant bloodstream infection afflicting 2 individuals in septic shock
• None of the available antibiotic substitutes improved the osteomyelitis in 8 individuals, even after they received longer-term treatment.
• A complicated urinary tract infection and severe renal failure in 4 patients.

The treatment has demonstrated an amazing 100% clinical cure rate, according to Wockhardt, among thirty critically ill patients with a variety of life-threatening, extensively drug-resistant Gram-negative infections. These individuals suffered from a difficult range of infections brought on by a variety of extremely resistant Gram-negative organisms, such as Pseudomonas, Klebsiella, E. Coli, Acinetobacter, and Serratia. Necrotising fasciitis, empyema, osteomyelitis, ventilator-associated pneumonia, bloodstream infections, and urosepsis were among these infections.

Of these patients, twenty or so had previously shown no response to antibiotic combinations such as ceftazidime/avibactam + aztreonam + polymyxin B/colistin, and ten had shown resistance to colistin/polymyxin B treatment. In addition, eight patients who were in septic shock were being treated with Zidebactam and Cefepime.

Doctors first tried treating patients with colistin or polymyxin B before using Zidebactam/Cefepime with the Central Drugs Standard Control Organization (CDSCO) compassionate use permission. Regretfully, without treating the infections, this resulted in serious nephrotoxicity and neurotoxicity.

To expedite Zidebactam/Cefepime’s global registration and marketing authorisation, a multinational Phase 3 trial is presently being carried out. Research on clinical pharmacology and other Phase 1 investigations were conducted in the United States.