Madam Therapeutics

News Archive

Genes linked to antibiotic-resistant superbugs found in Arctic

Genes associated with antibiotic-resistant superbugs have been discovered in the high Arctic, one of the most remote places on earth, showing the rapid spread and global nature of the resistance problem. This reported by the English newspaper the Gardian. The discovery of these genes, possibly carried by birds or humans, shows rapid spread of crisis

The genes were first identified in a hospital patient in India in 2007-8, then in surface waters in Delhi in 2010, probably carried there by sewage, and are now confirmed in soil samples from Svalbard in the Arctic circle, in a paper in the journal Environment International. They may have been carried by migrating birds or human visitors, but human impact on the area is minimal.

While the genes, called blaNDM-1, have been identified in soil on the Norwegian archipelago, the presence of superbugs has not. The genes can confer on bacteria resistance to carbapenems, which are antibiotics of last resort for the treatment of human diseases.

Antibiotic resistance threatens a global “apocalypse”, England’s chief medical officer, Dame Sally Davies, has warned, and last week the health secretary, Matt Hancock, called it a bigger threat than climate change or warfare. Common operations could become life-threatening and rapidly spreading and evolving diseases could overcome our last medical defences, reversing nearly a century of remarkable progress in human health.

Madam Therapeutics is developing new medicines that aim to overcome the problem of antimicrobial resistance. Madam Therapeutics is a One-Health company, with different development programs for human health, as well as animal health. Our lead molecules are SAAP-148 for use in infections in humans, and p10 for treatment of infections in animals.


Remko van Leeuwen features in video from Holland Bio

On January 24th, HollandBIO celebrated with its members and relations its first lustrum during the HollandBIO Year Event in the heart of Amsterdam. The event for the Dutch biotech sector was once again full of innovation, inspiring entrepreneurship and a healthy dose of humor. The opening video made it clear at a glance how the life sciences sector already contributes to a sustainable and healthy society, what innovations are on the horizon and the important role of HollandBIO to clear away the obstacles biotech frontrunners on their way from lab to meet society. Remko van Leeuwen, CEO from Madam Therapeutics is one the entrepreneurs that were selected to talk on their passion for biotech. Remko van Leeuwen, as well the other
entrepreneurs look back at the first five years HollandBIO and, of course, ahead: in the next five years, HollandBIO will once again be full of enthusiasm to pave the way for biotech innovations.

UK announces at World Economic Forum in Davos that it will trial a new payment model for antibiotics

BBS news announced today that the drugs advisory body in the UK, the UK National Institute for Health and Clinical Excellence, and NHS England will trial a new payment model that means pharmaceutical companies that development new antibiotics will be paid for drugs based on how valuable the medicines are to the NHS, rather than by the quantity of drugs sold.

Health Secretary Matt Hancock, launched the government’s 20-year vision at the World Economic Forum at Davos, Switzerland. “Antimicrobial resistance is as big a danger to humanity as climate change or warfare. That’s why we need an urgent global response”, he argues.

Traditionally, drugs companies are paid for the amount of antibiotics they sell. This has led to a “market failure” where companies are incentivised to sell existing antibiotics, rather than innovate and develop new treatments for infections where they are most needed.

By changing to a model where companies are paid based on how valuable the medicines are to the NHS, the UK government anticipates that companies will start to invest in the development of new, high-priority drugs.

Developing such new, high-priority drugs to fight bacterial infections is precisely what Madam Therapeutics has been doing since its start in 2011. The executive board from Madam Therapeutics welcomes this critical step by the UK government, and hopes that other European and other governments will follow soon.

Source: BBC News

Madam Therapeutics has been selected for a pitch at the upcoming edition of Innovation for Health.

Innovation for Health has announced today that Madam Therapeutics has been selected for a pitch at the upcoming edition of Innovation for Health on 14 February in Rotterdam. We are amongst 10 companies that are developing an healthcare innovation, and will get the opportunity to pitch our company and innovation to key players and decision makers in Health & Life sciences sector on 14 February at Innovation for Health and Global Investor Forum in Rotterdam!

More info

European Biotechnology Magazine: novel antibiotics become a more interesting investment opportunity.

In autumn, stakeholders across the globe pledged to take more action in the fight against antimicrobial resistance (AMR). Whereas from the “push” side new public and private initiatives appeared on the screen, discussion about which “pull” mechanism should be started first is in full swing.

Meanwhile, small and medium-sized companies combine forces aiming to propel preclinical and early clinical R&D.

Just recently, Kevin Outterson, head of US-based financing vehicle CARB-X, stated on Twitter  on the departure of Melinta Therapeutics from the development space “Does anyone need more proof that the way we pay for antibiotics is thoroughly broken and we need delinked reimbursement reform immediately?”

Kevin Outterson, CARB-X

European Biotechnology Life Science and Industry Magazine now reports that the business case for new antimicrobial is rapidly getting better, thanks to new funding instruments.

The magazine for example quotes FDA commissioner Scott Gottlieb, who advocates for stronger “pull” incentives, including new reimbursement models that would provide milestone payments and subscription fees for new FDA-approved antibiotics with demonstrable clinical and social values.

Scott Gottlieb, FDA commissioner

Pilot projects based on new market incentive models are also prepared at NICE in the United Kingdom, as AMR experts told European Biotechnology, but currently financing is still under discussion. In most other European countries, however, government‘s priority action goes into push funding.

More on this topic via this link.


Estimated burden of infections with antibiotic-resistant bacteria in the EU much higher than previously thought

In The Lancet Infectious Diseases, Alessandro Cassini and colleagues describe how they measured the health burden of five types of antibiotic-resistant infection (invasive and non-invasive) caused by eight bacteria with 16 resistance patterns in the EU and European Economic Area (EAA).

The estimates, for the 1st time presented as disability-adjusted life-years (DALYs), are truly shocking.

Evaluation of the burden of infectious diseases can be challenging because they occur at different time scales and are influenced by many factors (ie, demography, epidemiological setting, population ageing, and method of measurement).

Cassini and colleagues report the first attempt to quantify DALYs for other resistant infections.
By using this new method, their study adds to the evidence base on the burden of antimicrobial resistance and could have a crucial role in fighting such resistance. By providing for the first time DALY data for countries with a high burden of antimicrobial resistance, this study calls for increased political awareness of, and commitment to, antimicrobial resistance.

New strategies in the treatment of infections are therefore highly warranted, as this study confirms that antibiotic resistance (antimicrobial resistance, AMR) is emerging much more rapidly than originally thought. This resistance will increase over the coming years and decades because of the excessive use of traditional antibiotics in humans and animals.

Madam Therapeutics is developing SAAPs as a new class of antimicrobial agents are highly active against resistant bacteria and have a very favorable tolerance profile. Our SAAPs combine two characteristics essential for such new strategies: powerful killing of bacteria and limited likelihood of emerging resistance.

LUMC Scientist Peter Nibbering interviewed on Dutch Radio News show on SAAP-148

Peter Nibbering, Associate Professor at the Leiden University Medical Center, was interviewed on the Dutch radio news show Focus about his research to develop strategies (and agents) to prevent and treat bacterial/fungal infections not treatable with current antiinfectives. In this interview he talks about SAAP-148, that was developed and investigated in his clinic in collaboration with Madam Therapeutics.

The interview can be listened to via the website of the news show Focus

Madam Therapeutics has been awarded a grant from the Netherlands Antibiotic Development Platform (NADP)

Madam Therapeutics is pleased to announce that it is one of the 4 companies in the Netherlands that have been awarded a novel grant from the Netherlands Antibiotic Development Platform (NADP).

An important objective of NADP is to increase the productivity of research and development for new antibiotics and alternatives. In order to promote the accelerated development of promising ‘leads’, NADP has developed a financing instrument specifically for this purpose: the NADP Vouchers.

These vouchers can be used in various phases of the drug development process to gain advice and intensive supervision of research projects from independent consultants or contract research organisations that have specific knowledge and expertise pertinent to the pharmaceutical development process and clinical applications. The options vary from lead identification and optimisation, patent applications, and market analysis to pre-clinical drug development.

Applications were received from different types of organisations: 1 university, 2 university medical center, 1 university of applied sciences, and 4 SMEs.

Following expert review, the NADP Board decided on awarding 8 out of 13 submitted applications. ‘Awarding 8 out of 13 vouchers forms a promising start for our goal to accelerate research and development of new antibiotics and alternatives’ says Cees de Joncheere, chair NADP Executive Board in a press release.

Madam Therapeutics will use the voucher to support the development of it’s lead molecule SAAP-148.

We are preparing our visits to World Anti-Microbial Resistance Congress and BioEurope

Remko van Leeuwen and Leonie de Best are preparing their respective visits to the 4th Annual World Anti-Microbial Resistance Congress, Washington DC, USA (October 25 – October 26) and
BioEurope, Copenhagen, Denmark (November 5 – November 7). Remko will visit the Anti-Microbial Resistance Congress, while Leonie will attend BioEurope.

At both meetings there are plenty of opportunities to network with us, for example during partnering meetings, program sessions, during lunch, receptions, in the exhibition, and the special evening networking receptions. If you are attending one of the meetings, send us a partnering request or respond to this post, and will arrange a meeting with you.



South Africa: Klebsiella pneumoniae outbreak kills six newborns

An outbreak of Klebsiella pneumoniae at the Thelle Mogoerane Regional Hospital that began several weeks ago has grown to a dozen neonatal infections, including six deaths as is reported by various news outlets.

Klebsiella pneumoniae is a bacterium that is known to cause different types of healthcare-associated infections, such as pneumonia, meningitis, sepsis, wound or surgical site infections. Due to their increasing resistance to a class of antibiotics known as carbapenems, some strains of Klebsiella bacteria can cause infections which can longer be treated by carbepenems.

Persons who are at risk for infections with carbapenem-resistant organisms such as Klebsiella are those who have severe illness, surgical patients, patients who stay in hospital for prolonged periods, persons undergoing organ or stem cell transplantation, persons in intensive care and those who are on mechanical ventilation. Although less common, some persons can also acquire infection in the community.

Madam Therapeutics is developing a new class of antibiotics (SAAPs) that has a much higher barrier to resistance development. Carbapenem-resistant organisms such as Klebsiella are to SAAP-148. SAAP-148 is in clinical development, and not yet available for clinical use.