New antibiotic starts the long journey to market

Such investment in research is essential as the world needs to take urgent, coordinated action against antibiotic resistance or face an era in which common infections and minor injuries that have been treatable for decades can once again kill. In the EU alone, drug-resistant infections lead to around 25 000 deaths each year.

Part of the solution is encouraging the prudent use of antibiotics to prevent resistance from developing in the first place – the focus of this year’s European Antibiotic Awareness Day on 18 November.

Collaboration yields results

The EU is contributing with investment in research. For example, the successful NABATIVI project began by investigating a promising new drug, POL7080. Project partner Polyphor, a small Swiss-based company, had previously identified POL7080 as a possible antibiotic for one of the most dangerous infections, Pseudomonas aeruginosa. The bacterium is often found in hospitals, infecting cystic fibrosis patients, people with weakened immune systems – such as cancer patients – and those in intensive care.

NABATIVI helped Polyphor to complete the necessary pre-clinical studies and phase 1 clinical trials of POL7080, which showed that it is safe for patients, in March 2013.

In November 2013 the company concluded a worldwide licensing agreement with pharmaceutical giant Roche to take the drug into phase 2 trials – testing its efficacy on clinical infections. The link-up with Roche is an important step, as only two new classes of antibiotic have been put on the market in the past 30 years.

“Up to now the big players were not really interested in investment in new antibiotics,” said project coordinator Alessandra Bragonzi of San Raffaele hospital in Milan. “This is the first time for many years that a big pharma company has invested in the antibiotic area.”

NABATIVI’s partners, six universities and three SMEs from seven countries, also studied the 5 000 genes of P. aeruginosa – and other bacteria – to identify many other targets and likely drugs. Now the project has ended, they are looking for further funding to investigate the potential for new antibiotics.

The EU-funded collaborative approach was essential to NABATIVI’s success. The project could be a model for antibiotic development in the future: initial R&D is carried out by universities and SMEs, while the big investors step in when promising candidates are ready for the long, difficult and expensive task of testing and regulatory approvals.

“The EU is committed to the global fight against antimicrobial resistance,” said EU Research, Science and Innovation Commissioner Carlos Moedas. “Since 1999, the EU has invested nearly €800 million in transnational collaborative projects on antimicrobial resistance. Under Horizon 2020 we continue helping to save lives and reduce the €1.5 billion in healthcare expenses and productivity losses the EU incurs each year from drug-resistant infections.”

Horizon Prize

Other EU activities in this area include the new Horizon Prize for a Better use of Antibiotics which will be launched in February 2015. The €1 million prize challenges people to develop a rapid test that will allow healthcare providers to distinguish between patients with upper respiratory tract infections that require antibiotics and those that can be treated safely without them. The rules of the contest will give applicants total freedom to come up with the most promising and effective solution, be it from an established scientist in the field or from an innovative newcomer.

Upper respiratory tract infections (such as the common cold, bronchitis and infections of the sinuses, the middle ear and the throat) are behind many antibiotics prescriptions. However, many of these infections are due to viruses, where antibiotics are neither effective nor necessary. By stopping many patients from taking antibiotics needlessly, the test will prevent the side effects of such unnecessary treatment, eliminate the cost of prescribing the antibiotics and, most importantly, decrease the development of resistant bacteria.

Background

The European Commission has prioritised research to combat antimicrobial resistance over three successive Framework Programmes for Research, starting from 1999. Most projects have addressed human health, but others have focused on animal health, food and environmental aspects. On 15 November 2013 the EU funded 15 new research projects on antimicrobial resistance. Seven of the new projects aim to develop novel antibiotics, vaccines or alternative treatments for drug-resistant microbial infections. Others set out to identify better methods to use currently available antibiotics, study antibiotic resistance within the food chain, or use novel nanotechnology for the delivery of antimicrobial drugs.

The projects will also boost the European economy by directly supporting the work of 44 innovative SMEs. New projects will be funded under Horizon 2020, which was launched on 1 January 2014. The EU will also continue its successful collaboration with industry through the Innovative Medicines Initiative, for which a maximum EU contribution of €1.6 billion is foreseen.

Update November 2015

The company entered phase II clinical trials of teh Polyphor compound (POL7080). More at: http://www.polyphor.com/products/