Investigational antibiotic Zaynich clears drug-resistant infection in US cancer patient

New Delhi: In a medical case, a young immune-compromised cancer patient at Children’s Hospital of Orange County, University of California Irvine School of Medicine, has been successfully treated with the investigational antibiotic Zaynich (Zidebactam/Cefepime-WCK 5222).

The patient, hospitalized for nearly nine months due to chronic bilateral thigh infections caused by an extreme-drug-resistant strain of Pseudomonas aeruginosa, saw significant improvement after a four-week course of the antibiotic.

The patient, who has been battling multiple rounds of infections alongside a complicated clinical history that includes Acute Myeloid Leukemia, Chronic Kidney Disease, severe wound infections, including bilateral thigh wounds measuring about 28 x 11 cm and an abdominal wound had exhausted all available treatment options. In a critical move, the hospital sought and obtained access to Zaynich under the US FDA’s ‘Expanded Access IND’ provision, marking the first use of this antibiotic in the United States for such a case.

Until recently, the patient experienced severe pain, mobility challenges, and pressure ulcers with skin inflammation. Following two weeks of Zaynich treatment, the patient’s thigh wounds, previously resistant to other antibiotics, began to heal, and the bacterial load significantly diminished, allowing for successful xenograft placement. Subsequently, the abdominal wound healed completely, and the bilateral thigh wounds fully incorporated the grafts. By the end of the four-week treatment period, the wounds appeared to have healed, and the patient tolerated the medication well, with no adverse effects obviating the need for further cultures.

Zaynich (Zidebactam/Cefepime-WCK 5222) is currently in a multinational Phase 3 study aimed at securing global registration and marketing authorization. This follows earlier Phase 1 clinical pharmacology studies conducted in the US, showing promising results for this investigational drug in treating severe, drug-resistant infections.