WCK 5222, a brand new type of antibiotic from Wockhardt, has just been approved by the FDA for Phase 3 clinical trials. This new drug will strike a blow against the global epidemic of adaptive, multi-drug resistant bacteria or “superbugs,” which are becoming ever more prevalent.

“If you look at the disease burden, it’s high and it’s getting worse,” says Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease, “There are about 2 million infections per year in the United States caused by antibiotic resistance. That accounts for $20 billion in excess spending, as well as $35 billion in lost productivity.”

And at 700,000 deaths per year globally and growing, the seriousness of the problem cannot be underestimated. “We don’t want to revert back to the days when there were certain infections that we just couldn’t treat,” says Dr. Fauci.

A lack of research

Scientists have been stymied by superbugs for what now amounts to decades, due to a combination of the complexity of the bacteria as well as a lack of financial resources in antibiotic research.

Because of strict regulations and investments of time and labor, drug discovery and development ends up costing drug makers anywhere from $750 to $1 billion to bring a drug to the market.

“Antibiotics, which are used in one to two week courses,” says Dr. David Livermore, Lead on Antibiotic Resistance for Public Health England, “are less profitable than, for example, heart drugs which the patient takes for years.”

But, according to Dr. Fauci, this public health crisis is going to be more expensive in the long run. “It’s going to cost the health care industry that much more money,” he says, “That’s why it’s important to invest in the research that’s going to mitigate the problem.”

A new drug in pipeline

Thankfully, the forward-thinking creators of WCK 5222, Wockhardt, foresaw the threat of superbugs and have been committed to finding entirely new types of drug.

“We recognized that antibiotic research was in decline 20 years ago,” says Dr. Habil Khorakiwala, the chairman of the company, “We devoted our efforts to find new antibiotics, as we were sure that superbugs would emerge.”

Over the last 10 years global patents filed for antibacterial have declined by 60 percent, whereas patents filed by Wockhardt in these 10 years has increased by 315 percent.

“Over the last 10 years global patents filed for antibacterial have declined by 60 percent, whereas patents filed by Wockhardt in these 10 years has increased by 315 percent.”

Their latest development, WCK 5222, is a combination of zidebactam and cefepime. This superdrug introduces the first entirely new class of Gram-negative antibiotic treatment in 35 years. 

Zidebactam has a novel beta-lactam enhancer effect that overcomes multiple resistance mechanisms in Gram-negative superbugs, making it effective where other drugs have failed.

A public health priority

This new class of drug is a much-needed breakthrough for the global public health community. Earlier this year, the World Health Organization published a list of critical pathogens for which new drugs are urgently needed due to antimicrobial resistance.

Wockhardt’s WCK 5222 meets the urgent threat of carbapenem-resistant enterobacteriaceae  and serious threats like multidrug-resistant Acinetobacter baumanii , extended spectrum β-lactamase producing enterobacteriaceae and multidrug-resistant Pseudomonas aeruginosa.

Recognizing the critical need for this drug, the FDA has granted approval for Phase 3 clinical trials, granting it a Qualified Infectious Disease Product status for expedited approval. Because of the high priority of these drugs, Dr. Khorakiwala and his colleagues are hoping to have WCK 5222 approved and freely available by 2020 at the latest.

WCK 5222 is expected to be a life-saving destination therapy for serious hospital-acquired infections such as hospital acquired bacterial pneumonia, ventilator associated pneumonia and bloodstream infections. “Our break through drug, zidebactam, is the most promising remedy for these superbugs,” says Dr. Khorakiwala.

There is also currently movement in within the G20 nations to financially incentivize continuing discovery of novel antibiotics.