Wockhardt has high hopes for novel antibiotic Zaynich

Indian pharma group Wockhardt has completed a pre-filing meeting with the FDA and hopes to submit its new antibiotic Zaynich in the US and Europe later this year, eyeing a possible launch in fiscal 2026/27.

Zaynich is based on cefepime, a well-established beta-lactam antibiotic, combined with a novel beta-lactamase inhibitor called zidebactam that is designed to block a common antimicrobial resistance (AMR) mechanism and also has intrinsic antibacterial activity.

It is being developed for multidrug-resistant (MDR) Gram-negative infections – a market opportunity that Wockhardt has said could be worth up to $7 billion in the US and Europe – and has been awarded fast-track status by the FDA.

Earlier this year, Zaynich was given via a compassionate access route to a severely immunocompromised 15-year-old patient with acute myeloid leukaemia (AML) who had contracted a severe drug-resistant infection that had not responded to nine antibiotics across five different classes over a span of 45 days.

The patient – the third to be treated with Wockhardt's drug on a named-patient basis – saw the infection resolve after 41 days of treatment with Zaynich.

Gram-negative bacterial infections are a significant public health threat around the world, particularly organisms that can produce metallo-beta-lactamases (MBLa), enzymes that can make organisms resistant to almost all beta-lactam antibiotics.

MBL-producing Gram-negative bacteria are among the most challenging infections to control, are on the rise globally, and are a priority pathogen for the World Health Organization (WHO).

In a recently completed phase 3 trial (PDF) that involved 530 patients across the US, Europe, Latin America, China, and India, Zaynich achieved a clinical cure rate of 96.8% within seven to 10 days of the final dose.

In a financial filing, Wockhardt said that there are upwards of a million cases of Gram-negative infections every year in India alone that could be candidates for Zaynich treatment. The company has already filed for approval with India's regulatory authority and is hoping for a launch in the latter half of the current fiscal year.

Earlier this year, AbbVie claimed FDA approval for another novel beta-lactam/beta-lactamase inhibitor drug called Emblaveo (aztreonam/avibactam) to treat complicated intra-abdominal infections (cIAI), including those caused by Gram-negative bacteria.

AMR already kills a million and a half people every year worldwide, and that could reach 10 million deaths by 2050 unless there is a concerted effort to research new antibiotics, according to some estimates.