Wockhardt's Zaynich Shatters Drug-Resistance In Cancer Patients

Wockhardt, the Mumbai-based pharmaceutical and biotechnology firm, reported on Friday a milestone in its clinical trials: an investigational drug effectively treated a young cancer patient with compromised immunity in the United States. The patient, hospitalized for nearly nine months at Children’s Hospital of Orange County and the University of California Irvine School of Medicine,underwent a four-week course of Zaynich, an experimental antibiotic, under compassionate use for a chronic thigh infection.

The company states that this treatment enabled doctors to safely resume chemotherapy for the patient. Throughout the extended hospitalization, the patient faced recurring infections requiring multiple rounds of antibiotics. As conventional options dwindled, the hospital pursued access to Zaynich through an 'Expanded Access IND' provision approved by the USFDA.

According to the company, this case represents the inaugural use of Zaynich in the US against a challenging infection caused by extensively drug-resistant Pseudomonas. Additionally, the patient's clinical profile included a complex medical history involving Acute Myeloid Leukemia (a form of blood and bone marrow cancer), support from extracorporeal membrane oxygenation, Chronic Kidney Disease, bilateral thigh wounds, and an abdominal wound. The patient also endured severe pain, mobility issues, and pressure ulcers with localized skin inflammation.

In its latest announcement, the company disclosed that the infectious agent was metallo-beta-lactamase-producing Pseudomonas aeruginosa, known for its formidable resistance. According to the company, patients treated with Zaynich showed significant improvement in thigh wound healing within two weeks, with complete recovery observed in all cases. The treatment was well-tolerated by all patients, the statement confirmed.

Meanwhile, during the June 24, 2024 plenary session of the Clinical and Laboratory Standards Institute (CLSI), Zaynich received a susceptibility breakpoint of 64 mg/L for approximately 10 highly resistant Gram-negative pathogens. These breakpoints serve as crucial guidelines for clinicians in selecting the most effective antibiotics for treating various infections. While formal approval for Zaynich is pending, CLSI has designated these breakpoints as investigational to support ongoing clinical trials and compassionate use.

To date, approximately 30 patients have benefited from compassionate use, marking a milestone with the highest breakpoint ever awarded, as noted by Habil Khorakiwala, founder and Chairman of Wockhard. Zaynich is currently undergoing a multinational Phase 3 study expected to conclude by FY2025. During a recent press briefing, company leadership announced plans to seek regulatory approval within six months of trial completion, aiming for global market availability within eight to ten months thereafter.