Madam Therapeutics

News Archive

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.

Source: european-biotechnology.com

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.

Interview with CEO Remko van Leeuwen on Dutch News Radio Station BNR

Remko van Leeuwen, CEO of Madam Therapeutics, was interviewed today in “Zaken doen met”, a radioshow on the Dutch News Radio Station BNR.

“Zaken doen met” is advertised as the most entrepreneurial radioshow of the Netherlands.

During the interview, Remko van Leeuwen talks about the opportunities and difficulties he and CBO Leonie the Best have experienced in closing the 1st private funding round of 1,1M EUR that was closed earlier this week.

A replay of this interview can be listened to (in Dutch) via
https://www.bnr.nl/player/archief/20180904132500300

Remko van Leeuwen appeared in the same radio show just one year earlier. That interview can be replayed via https://www.bnr.nl/player/archief/20170901113300360 (also in Dutch)

New business report describes Madam Therapeutics as key player for the development of new treatments for burns

A new business outlook on the global burns market has been published this week. Madam Therapeutics is listed as a “dominating players with regards to growth of this particular market”.

The report `is portraying an in-depth study of the global burns treatment market, and covers the growth rate of the market during the anticipated time. Supplying a concise overview, the global Burns Treatment market research report verifies the assessment and volume of the Burns Treatment market in the upcoming period. Adocia, AlgiPharma AS, Amarantus Bioscience Holdings, Inc., American Gene Technologies International Inc., Biogenomics Limited, CytoTools AG, Destiny Pharma Limited, Lakewood-Amedex Inc, Madam Therapeutics B.V., MediWound Ltd., Mitochon Pharmaceuticals, Inc., Phosphagenics Limited, Se-cure Pharmaceuticals Ltd., Sinclair Pharma Plc, Stratatech Corporation, Tissue Therapies Limited, USV Pvt Ltd are dominating players in the global Burns Treatment market.

The latest research report also encloses key features contributing to the development of the global Burns Treatment market.

Madam Therapeutics closes first financing round to develop novel antibiotics against drug resistant bacteria

Madam Therapeutics today announced the closing of its first financing round of 1,1M EUR. The investment comes from a network of European business angels facilitated by Ekoy Investment Partners, De Investeerders Club and Investormatch.

The new funding will be used to continue and accelerate the clinical development of Madam Therapeutics’ lead candidate SAAP-148, by executing a first-in-men proof of concept study starting early next year and preparation of the following clinical phase II trial.

Lead candidate: SAAP-148
When a small subset of bacteria survives antibiotic treatment e.g. by mutations, an infection can get out of control fast. As these resilient microbes thrive, they can group together on a surface—like a wound or a medical device—and encase themselves in a slimy protective layer known as a biofilm. Such biofilm infections “are the really nasty things for patients,” says immunologist Peter Nibbering at Leiden University Medical Center in the Netherlands with whom Madam Therapeutics closely collaborates.

Madam Therapeutics and a team of esteemed Dutch scientists from o.a. Leiden University Medical Center (LUMC) and Amsterdam Medical Center(AMC) have developed a new antibiotic with improved characteristics to fight a broad spectrum of infections. In a recent editorial comment on the new compound on the website of the scientific journal Science, Dr Kim Lewis, a microbiologist at Northeastern University in Boston says that the candidate adds “an important piece … to the puzzle of creating a perfect antibiotic”.

Dr. Remko van Leeuwen, CEO of Madam Therapeutics, comments on this first financing round:
“Most of the antibiotic drugs currently in the worldwide clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions. Antimicrobial resistance is a global health emergency. There is an urgent need for more research and development for antibiotic-resistant infections, otherwise people will die from very simple infections”. Remko van Leeuwen is thrilled to welcome the group of investors to Madam Therapeutics.  “The recent investment clearly represents a growing commitment and understanding from the investment community to the development of new antimicrobial agents and reflects the potential of our drug programs.”

Jaap Wieling, a spokesmen of the investor group says: “This funding will allow Madam Therapeutics to take important steps forward with its lead candidate SAAP-148. Where most traditional antibiotics have a slow acting mechanism of action, SAAP-148 kills the bacteria very fast by attacking them directly from the outside, puncturing the cell membrane and make it deflate. Now with the backing of this solid investor base, the seasoned team will be able to explore the full potential of its technology”.

Ron Byron, Partner at Ekoy invest that helped to successfully put together the investment group says: “From my experience in marketing of antibiotics, I am very much aware of growing need for new antibiotics. Unless antibacterial development is re-energised, there is a serious risk that a growing proportion of infections, especially in hospitals, will become effectively untreatable leading to many unnecessary casualties.”

About Madam Therapeutics
Madam Therapeutics is a privately held company from the Netherlands that is developing Synthetic Anti-Microbial and Anti-Biofilm Peptides (SAAPs) to combat resistant bacterial infections. Our SAAPs have a powerful and fast killing effect towards a very broad spectrum of bacteria and have a very favorable tolerance profile. Our SAAPs combine two characteristics essential for such new strategies: powerful killing of (resistant) bacteria and limited likelihood of emerging resistance. To date, Madam Therapeutics and her academic partners have raised a substantial amount of non-dilutive funding for the development of a family of over 300 unique SAAPs and a pipeline of SAAP based products for multiple infectious diseases.
Madam Therapeutics is currently actively fundraising for the next stages of clinical trials and broadening its pipeline of products, besides looking for co-development partners for further development and commercialization of its products.

For more information, please contact:
Remko van Leeuwen
CEO
+31 71 2040 105 Extension 100
press@directvps.nl
http://vps2319.directvps.nl

Investor relations:
investors@directvps.nl

National Alert System for Critical Antimicrobial Resistances: death rate as high as 50% for some bloodstream infections In Australia

The latest six-monthly report for the National Alert System for Critical Antimicrobial Resistance (CARAlert), released by the Australian Commission on Safety and Quality in Health Care, highlights the continuing threat of antimicrobial resistance by dangerous bacteria.

Carbapenemase-producing Enterobacteriaceae (also known as CPE) and Neisseria gonorrhoeae continue to be the most commonly reported organisms with critical resistances to antimicrobials across Australia, according to the report. CPE is a Gram-negative bacteria that is routinely encountered in hospitals and other healthcare facilities, while N. gonorrhoeae is a bacterial sexually transmitted infection.

“The finding that CPE remains prevalent in Australian hospitals is concerning,” said the Commission’s Senior Medical Advisor for the AURA Surveillance System, Professor John Turnidge. “This group of bacteria has the ability to cause common infections, has limited treatment options and can have a death rate as high as 50% for bloodstream infections.