Wockhardt, a Mumbai-based Indian pharmaceutical and biotechnology company, on Friday announced that its investigational drug has successfully treated a young immuno-compromised cancer patient in the United States.
With no treatment options left, the hospital sought access to Zaynich under a provision termed as ‘Expanded Access IND’ granted by the USFDA.
The company claims that after two weeks of Zaynich treatment, the thigh wound beds started looking better and eventually all the wounds healed.
Meanwhile, Dr Mahesh Patel, Director, Drug Discovery Research, Wockhardt calls this drug the “new penicillin” and it took 25 years to develop this drug.
However, with 2-3 weeks of treatment with 5222 (Zaynich) he was cured.
Wockhardt, a Mumbai-based Indian pharmaceutical and biotechnology company, on Friday announced that its investigational drug has successfully treated a young immuno-compromised cancer patient in the United States.
According to the company’s statement, the patient was hospitalised for nearly nine months at Children’s Hospital of Orange County, the University of California Irvine School of Medicine and he was treated with four weeks of Zaynich, the experimental antibiotic, for chronic thigh infection under compassionate use.
The drugmaker claims that this drug helped the doctors in resuming the chemotherapy.
Also Read Did you notice a band on Virat Kohli’s wrist? Know all this about display-less fitness device Fierce competition from local firms forcing pharma MNCs to downsize in India From fitness trackers to lifesavers: The future of wearable health-tech Our primary goal is to double our revenue, enter higher-margin niche segments and increase footprint: Dr. Saloni Wagh, Director, Supriya Lifescience Ltd.
“During the long hospital stay, the patient grappled with multiple rounds of infections necessitating extensive use of several antibiotics. With no treatment options left, the hospital sought access to Zaynich under a provision termed as ‘Expanded Access IND’ granted by the USFDA.
According to the company, this case marks the first instance in the US where Zaynich has been employed to combat a complex infection caused by extreme-drug-resistant Pseudomonas.
Moreover, the patient has a complicated clinical history of Acute Myeloid Leukemia (Blood and Bone Marrow cancer), extracorporeal membrane oxygenation support, Chronic Kidney Disease, and bilateral thigh wounds, and another wound in the abdomen. The patient was also in severe pain, mobility challenges, and pressure ulcers at various areas of skin with inflammation.
Also Read Sun Pharma completes Taro merger to make it a wholly-owned private company
The company revealed in its statement that the infecting pathogen was metallo-beta-lactamase-harbouring Pseudomonas aeruginosa, which is one of the toughest mechanisms known.
The company claims that after two weeks of Zaynich treatment, the thigh wound beds started looking better and eventually all the wounds healed. Zaynich was well-tolerated by the patients, it stated.
Meanwhile, during the June 24, 2024 plenary session of Clinical and Laboratory Standards Intitute (CLSI), Zaynich was granted a susceptibility breakpoint of 64mg/L for around 10 Gram Negative pathogens showing high resistance rates.
These breakpoints guide the doctors in the selection of the most efficacious antibiotics for treating various infections. As Zaynich’s formal approval is pending, CLSI has designated these breakpoints as investigational breakpoints to facilitate clinical trials and compassionate use. Till now, around 30 patients have been treated under compassionate use. Never before has such a high breakpoint been awarded, Habil Khorakiwala, founder and Chairman, Wockhard claimed.
Currently, Zaynich is undergoing a multinational Phase 3 study, which is expected to be completed by FY2025. During a press briefing on Friday, the company’s top management announced that after the completion of trial, the drug will be applied for approval within six months and the product will be marketed in the next eight to ten months as per the global time frame.
“We can’t do drug research alone as a company. We need a network. We have 30-plus organizations who outsource some of our networking on a global basis,” Khorakiwala told FinancialExpress.com.
The company also said this drug should be used when all other options fail. “We have achieved 100 percent success in this. 30 days to 70 days was the drug administered. No side effects were observed,” Khorakiwala said. He also added that this drug would only be used in an ICU setting.
Meanwhile, Dr Mahesh Patel, Director, Drug Discovery Research, Wockhardt calls this drug the “new penicillin” and it took 25 years to develop this drug. He also shared another case in which there was complete necrosis of the facial skin on a patient in Apollo Chennai. However, with 2-3 weeks of treatment with 5222 (Zaynich) he was cured. He also had underlying cancer and hence was immune suppressed, Dr. Patel informed.
The drug is expected to get global approval in the US market in the middle of FY26.
