Madam Therapeutics

News Archive

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.

 

Emergence of a new multidrug-resistant Escherichia coli clone in the United States

A new study in Clinical Infectious Diseases describes the emergence of a new multidrug-resistant Escherichia coli clone in the United States.

In a multicenter surveillance study conducted at nine sites in four US cities (Seattle, Los Angeles, Minneapolis, and New York) in 2016-2017, researchers collected 6,349 consecutive clinical E coli isolates from urine, blood, or wounds and tested them for susceptibility to antibiotics and production of extended-spectrum beta-lactamase (ESBL) production. They performed additional analysis on fluoroquinolone-resistant (FQ-R) E coli isolates to determine clonal identity and resistance mechanisms. They were looking to gain further insight into hospital reports of the occurrence of FQ-R E coli belonging to the clonal group ST1193.

Of the 6,349 E coli isolates, 1,314 (20.7%) were FQ-R and represented 45 clonal groups overall. At each site, the most prevalent clonal group among FQ-R isolates was ST131 H30 (per-site mean, 45.4%), which emerged in the late 1990s and has become the most prevalent worldwide pandemic clonal group of multidrug-resistant E coli. The second most prevalent was ST1193 (23.2%). But while the prevalence of H30 did not change between 2016 and 2017, either overall (45.8% in 2016 vs. 46.1% in 2017) or at any single site, the prevalence of ST1193 increased both overall (18.4% in 2016 vs. 25.9% in 2017) and at six sites. In addition, at four sites that provided data on 2011 FQ-R isolates, ST1193 exhibited a seven-fold overall prevalence increase (3.4% in 2011 to 23.4% in 2016-2017).

In addition to being FQ-R, the ST1193 isolates were often co-resistant to trimethoprim-sulfamethoxazole and tetracycline, but unlike ST131 H30 remain susceptible to most beta-lactam antibiotics. The researchers also found that ST1193 E coli appears to target younger patients and is less likely to be isolated from blood.
The authors say the findings, along with reports of ST1193 being isolated in hospitals in Europe and Asia, suggest that ST1193 is likely to be a pandemic clonal group similar to H30. They conclude, “Discovery of the basis for the global expansion of ST1193 could provide insights into how successful clonal groups of multidrug-resistant E. coli emerge and what interventions could limit their spread.

Madam Therapeutics develops a new antibiotic called SAAP-148, that has as much higher barrier to resistance development compared to traditional antibiotics. SAAP-148 has demonstrated activity against multidrug-resistant Escherichia coli clones. SAAP-148 may therefore help to limit their spread

 

Source: CIDRAP / AMR-Insights

‘Most important antibiotic legislation in a generation’ discussed in US House of Representatives

Representatives in the US House of Representatives yesterday introduced a bipartisan bill to encourage the development of new antibiotics, a move one expert called the most important antibiotic legislation in a generation.

Currently, only a few drug companies are involved in antibiotic research and development, because the cost of developing the drugs is so high and profit margins are so slim. Most new developments are modifications of existing drugs, and it’s been three decades since the last new class of antibiotics was discovered.

Experts have been advocating for “push” incentives that spur development, but that type doesn’t ensure that companies get an adequate return on their investment. On the other hand, the World Economic Forum said in report last week that effective “pull” incentives could be used to promote antibiotic stewardship, availability, and access.

Based on the best available models, it can predicted that innovative approaches to the development of new antibiotics, such as transferable exclusivity awards, would spur the development and approval of 10 to 20 powerful new antibiotics over the next three decades, giving us what we need to battle superbugs.

The bill, called the REVAMP Act of 2018would award 12 extra months of market exclusivity for drugs designated as priority antimicrobial products. A committee of representatives from the Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services BARDA, and physicians would develop a list of critical-need antimicrobials, focusing on the ones with unmet medical needs and multi-drug resistance.

Drug developers could request designation as priority antimicrobial products before and after filing for licensing, with the HHS secretary and the committee approving the request if they find it treats or prevents priority diseases from multidrug-resistant bacterial or fungal pathogens.

The bill contains several conditions for drug makers, such as tracking resistance data and assessing stewardship activities. As an incentive, drug makers can convey the award to one or more drugs and split up the award periods.

In a thread on Twitter yesterday after the bill was introduced to Congress, Kevin Outterson, executive director of the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), said the proposal is the most important legislation in a generation. He said it’s hard to create “pull” incentives that companies trust to survive annual appropriations from Congress.

“REVAMP uses conveyable FDA exclusivities that can be applied to OTHER drugs as the prize,” Outterson said, estimating that the incentive is likely to be worth more than $ 1 billion.

In other words, the bill would pay for antibiotic innovation through delayed generic entry in the US on other drugs, he said. “Antibiotics make other therapies possible; this spreads those costs on other drug classes.”

Strong stewardship conditions are part of the bargain, and the companies make money on the prize, not the volume sold. “Paying more for value than volume, which is what you want in antibiotics,” Outterson wrote.

A key political feature of the bill is that it is budget neutral, he said, noting that studies begin after five prizes so that Congress will have information to consider renewal after 10 awards.

The antibiotic pipeline is near collapse, and the country needs to act now to preserve the infrastructure to support antibiotic research and development, Outterson said. “The house is on fire; let’s not argue about the perfect fire truck while it burns down.”

 

Source: Center for Infectious Disease Research and Policy (CIDRAP)
University of Minnesota

Rise of carbapenem-resistant Enterobactericaeae: A threat to health in Europe

Infections with bacteria resistant to carbapenems, a group of highly effective antibiotics, pose a significant threat to patients and healthcare systems in all EU countries, warns ECDC in a Rapid Risk Assessment.

Resistance to carbapenems has been reported with increasing frequency and geographical spread since the beginning of the 1990s. The global rise of carbapenem resistance in a certain family of bacteria called Enterobacteriaceae, or carbapenem-resistant Enterobactericaeae (CRE), represents a threat to healthcare delivery and patient safety.

“We should be very concerned about the rise in carbapenem resistance in the EU/EEA as there are very few options for the treatment of patients with CRE infections” says Dominique Monnet, Head of ECDC’s Antimicrobial Resistance and Healthcare-Associated Infections Programme.

 

 

“In recent years, the proportions of carbapenem resistance in Klebsiella pneumoniae – a type of Enterobacteriaceae – rapidly increased to high levels in Greece, Italy and Romania. The same could happen to other EU/EEA countries if appropriate measures are not taken. But the spread of CRE can likely be controlled in most countries through the implementation of appropriate prevention and control measures in hospitals and other healthcare settings.”