Answering a global call to action


Hasan Jafri, MD

The World Health Organization said in a report last year that the rise of drug-resistant bacterial infections is no longer merely a prediction for the future, but a serious threat to every region of the world.

Those of us who’ve spent our lives working with infectious diseases have seen this coming for quite some time, and there have been numerous national and international calls to action—each more urgent than the one before.

Today, we may be closer than ever to a concerted effort towards new solutions and a paradigm shift for managing serious bacterial infections and staving off resistance

Four years ago, the European Commission called for “unprecedented collaborative research and development efforts to bring new antibiotics to patients.” This included the launch of the sixth Innovative Medicines Initiative (IMI) Call for Proposals in 2012 as part of a program titled New Drugs 4 Bad Bugs, or ND4BB. Less than a year later, the COMBACTE consortium, an unparalleled public-private partnership that includes academia and industry, was formed.

COMBACTE—or Combatting Bacterial Resistance in Europe—is unique for a number of reasons. First, its goal is to promote the clinical development of new drugs in the anti-infectives field. No one else is doing this. Second, the diversity of experts who have been coalesced is remarkable. We have specialists coming from research bodies, universities, hospitals and pharma/biopharma industries in fields that include microbiology, epidemiology, translational medicine, clinical trial design and preclinical work. All of this comprises a network driven toward developing high-quality, novel drugs targeting infections caused by drug-resistant pathogens. No one else is doing that, either.

Global mission, following the science
Though this is a European-based initiative, its mission and impact is global. And, where there’s a focus on developing new antibiotics, there also is a broader vision to follow the science of new technologies and drug innovations.

This is where MedImmune comes in. As part of our participation in the COMBACTE consortium, we’ve already begun two initiatives—both involving the development of novel monoclonal antibodies (mAbs) to address drug-resistant infections. One is a Phase II trial named SAATELLITE and is the first interventional trial ever designed and executed within COMBACTE. We randomized our first patient with MEDI4893, an investigational molecule MedImmune developed that targets alpha toxin, a key toxin produced byStaphylococcus aureus (S. aureus), one of the leading bacteria associated with hospital-associated infections and linked to drug-resistance issues. The SAATELLITE trial represents a paradigm shift in the infectious disease field, studying a pre-emptive approach using a mAb to help prevent ventilator-associated pneumonia (VAP) and nosocomial pneumonia due to S. aureus.

The second initiative—known as COMBACTE-MAGNET (Molecules Against Gram-Negative Infections)—will investigate a new approach for preventing respiratory infections in intensive care unit (ICU) patients and new treatment options for patients with life-threatening infections due to Gram-negative bacteria (GNB) infections. The project will include groundbreaking multinational studies with MEDI3902, the MedImmune mAb being investigated for the prevention of nosocomial pneumonia caused by the GNB Pseudomonas aeruginosa (P. aeruginosa).

We are truly on the forefront of something spectacular here. There is a lot of excitement with the COMBACTE model and other programs that come under the IMI/ND4BB platform. This public-private model, the coalescing of world-renowned clinicians and researchers, and the ability we have to act swiftly according to the science—this is the right way to develop drugs.