US FDA agrees to fast track trial process for Wockhardt's superdrug

This is the categorisation based on which US FDA has given this special QIDP status.  Wockhardt has taken this antibiotic for a worldwide clinical development. This drug in scientific community is well documented by a large number of oral and scientific poster presentation at ASM Microbe at Boston and ECCMID at Amsterdam and ID week at New Orleans.

One of the constituents of WCK 5222 is zidebactam, which is an antibiotic with a novel β-lactam enhancer mechanism that facilitates overcoming of multiple resistance mechanisms in Gram negative superbugs, including the most dreaded mechanism called New Delhi metallo β-lactamase (NDM) which renders the last line of antibiotics (carbapenems) ineffective. WCK 5222 is also active against the recently reported colistin-resistant strains of Gram negative pathogens.

Thus, WCK 5222 is expected to be a life-saving destination therapy for serious hospital-acquired infections such as pneumonia, ventilator associated pneumonia, blood stream infections. 

According to Lord Jim O’Neill report on ‘The Review on Antimicrobial Resistance’, currently more than 700,000 deaths are attributable to antimicrobial resistance every year and it is estimated that by year 2050, if no effective drugs are developed for these superbugs, 10 million lives a year and cumulative $ 100 trillion of economic output are at risk due to the rise of drug-resistant infections.

“Wockhardt believes on successful clinical outcome of superdrug WCK 5222, millions of lives will be saved and hope that Lord Jim O’Neill’s report prediction may not come true,” said the company in a press release on April 3, 2017.

The world is grappling with the problem of bacterial drug-resistance against currently known antibacterial. There is an active proposal in G20 to support antibiotic research. G20 views that lack of antibiotics indicates that antibiotic research is not commercially viable. This can be seen from the fact that from the period 1983 to 1992 there were 30 antibiotics launched and approved in regulated developed countries. However, since 2008 to 2016, there are only 7 drugs approved. India constitutes roughly 15 percent of the usage of antibiotics in the world. Based on successful launch of antibiotics they recommend giving outright grant of incentives to pharmaceutical industry. 

Over last 20 years, Wockhardt synthesised over 6000 chemical molecules and now has five drugs which has entered phase II and phase III clinical trials. All these drugs have been given by US FDA a breakthrough status, i.e QIDP. Three of these drugs are for gram positive organism and two of these drugs are for gram negative organism.

Over 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.

There are 10 other companies who are involved in antibiotic research and collectively have 11 drugs in the pipeline at clinical stage. However, Wockhardt alone has five drugs.

Wockhardt expects global clinical launch of WCK 5222 during the year 2020-21.

Antimicrobial resistance (AMR) occurs when micro-organisms (as bacteria, viruses, fungi and parasites) change in ways that render the medications used to cure the infections they cause, ineffective. When the microorganisms become resistant to most antimicrobials they are often referred to as ‘superbugs’. These resistant infections are usually associated with higher rate of mortality, extended hospitalisation, can spread to others, and impose huge costs to individuals and society.

AMR is of particular concern in developing countries like India, as the burden of infectious disease is high and the healthcare spending is low. Today, India has one of the highest bacterial disease burden and the second highest antibiotics consumption in the world. Therefore, to overcome the morbidity and mortality due to these infections, novel antibiotics effective against superbugs have a critical role.

In recently concluded 7 year surveillance study in India sponsored by Bill and Melinda Gates Foundation covering major hospitals and community pantogens from 696 sectors of India have concluded that antibiotic resistance are significant against antibiotic in many cases of Klebsiella, Pseudomonas, Acinetobacter, E.Coli and S.aureus (MRSA) and it ranges 47 percent to 80 percent. These are life threatening organism. This is where WCK 5222 and other antibiotics in Wockhardt Drug Discovery programme will help to control the menace of superbug resistance.  

“We recognised that antibiotic research was on decline 20 years ago and we devoted our efforts to find new antibiotics as we were sure that the superbugs will develop resistance. Today more than 700000 lives are lost every year because of these superbugs and lack of antibiotics. Wockhardt’s break through drug, Zidebactam is the answer for these superbugs,” said the company.