Wockhardt’s Investigational Drug, Zaynich™ (Zidebactam/Cefepime) cures complex case of meningitis caused by pan – drug resistant super – bug under compassionate use

Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Chhatrapati Sambhajinagar 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com Mumbai, 19th September 2024 Wockhardt's Investigational Drug, Zaynich™ (Zidebactam/Cefepime) cures complex case of meningitis caused by pan-drug resistant super-bug under compassionate use In the past year, Wockhardt’s investigational drug, Zaynich™ (Zidebactam/Cefepime), has successfully treated over 35 critically ill patients in India and US who were suffering from extremely drug-resistant infections under compassionate use. This drug has once again demonstrated its effectiveness in managing complex, deep-seated infections. A recent notable case involved a 64 -year-old patient with Type 2 diabetes and hypertension, who had been battling pulmonary and meningeal tuberculosi s for about a year. Following a spinal puncture to withdraw cerebrospinal fluid (CSF), the patient developed fever, drowsiness, and unconsciousness, leading to mechanical ventilation and a diagnosis of bacterial meningitis. The condition was confirmed when CSF analysis identified a pan-drug resistant super-bug, Pseudomonas. Initial treatments with Ceftazidime/Avibactam, Aztreonam, and Meropenem failed to halt the patient's deterioration, marked by persistent fever spikes and increasing infection markers su ch as C -Reactive Protein (CRP), procalcitonin, and white blood cells (WBC). Due to the significant toxicity and limited ability of Colistin and Polymyxin in crossing the blood-brain barrier, these options were deemed unsuitable. Faced with no alternatives , a multi -disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use. Treatment was administered for three weeks. Remarkably, within a short period, the patient’s clinical condition improved, with CRP and procalcitonin levels decreasing, and the patient was successfully taken off the ventilator. CSF tests showed the eradication of the pathogen just one week into treatment, and subsequent tests confirmed the absence of Pseudomonas after three weeks of Zidebactam/Cefepime. The patient became clinically stable and all symptoms resolved leading to discharge from the hospital. The drug was well -tolerated throughout the treatment period. Meningitis, an inflammation of the tissues surrounding the brain and spinal cord, poses significant treatment challenges due to the difficulty of antibiotics in penetrating the blood-brain barrier. This case highlights Zidebactam/Cefepime’s remarkable ability to tackle infections in difficult-to-treat body sites. Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Chhatrapati Sambhajinagar 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com This represents the first case of nosocomial meningitis caused by multidrug -resistant Pseudomonas successfully treated with Zidebactam/Cefepime, underscoring its potential as a valuable therapeutic option. About ZaynichTM (Zidebactam/Cefepime, WCK 5222) ZaynichTM, combination of Cefepime and Zidebactam, is Wockhardt’s novel patented antibiotic, targeted towards multi -drug resistant Gram-negative infections. It is currently undergoing a multi -national Phase III study which would support its registration/marketing authorization globally. Earlier, multiple Phase I studies including clinical pharmacology studies with Zidebactam/ Cefepime were conducted in US. ZaynichTM (Zidebactam/Cefepime) is also undergoing a Phase II study in India for the treatment of carbapenem-resistant infections. About Wockhardt’s New Drug Discovery portfolio Over the period of 25 years, Wockhardt has focused its drug discovery efforts in the area of discovering novel medicines for multi -drug resistant infections. This has resulted in a portfolio of 6 products at various stages of clinical developme nt and commercialization, each of which have been granted Qualified Infectious Disease Product status by the US FDA.

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