Best-in-Class next generation anti-infectives to fight global anti-microbial resistance
Close to 5,000,000 deaths every year
An estimated 4·95 million deaths associated with bacterial resistance to antibiotics and 1·27 million deaths attributable to bacterial resistance, each year.
There is widespread consensus that antimicrobial resistance (AMR) represents an emerging and alarming threat to human health worldwide.
By 2050, the death rate could be as high as 10 million per year – that’s 1 death every 3 seconds. This is more than the number of people dying from cancer today.
We are working on the solution
The Problem of Antimicrobial Resistance
Development of new drugs and improvement of existing ones is key in the fight against antimicrobial resistance.
Lack of novel antibiotics
The lack of novel antibiotics is significantly compromising the survival and recovery of patients suffering from resistant infections, as well as our ability to fight simple bacterial infections in the future.
The development of novel antibiotics takes 6-10 years from discovery to approved use in the clinic. It is essential to act now.
development of new antibiotics has failed so far
There are various reasons why the development of new antibiotics has failed in the last decades. We see that the major hurdle is a simple intrinsic problem: the ‘low-hanging fruits’ have simply been picked. The “simple and obvious drugs” have been discovered and successfully used since world war II. However, bacteria were able to evolve within 10-60 years to become resistant to these “simple and obvious” drugs.
Drug screens for new antibiotics tend to re-discover the same lead compounds or with minor modifications towards approved drugs, to which bacteria can be resistant already. In general, discovery and development of antibiotics has become scientifically more complex, more expensive, and more time consuming over time.
A second problem is the fact that new compounds are not used once they are approved because of drug-sparing regimens (stewardship).
The third problem is caused by the fact that typically life-saving antibiotics are strongly undervalued i.e., their price is often only a few dollars in contrast to tens to hundredths of thousands dollars that are paid for cancer therapies that provide a life extension of several months to a few years.
This discourages pharmaceutical and biotech companies to develop such antibiotics as well as investors to invest in such developments.
Between 1940 and 1962, more than 20 new classes of antibiotics were approved and marketed. Since then, some new molecules, but belonging only to two new classes, have reached the market. Now, not enough analogues are reaching the market to keep up with antibiotic resistance.
Therefore, there is a constant need to develop new agents to keep up with the acquisition of resistance among pathogenic bacteria. Antimicrobials are vital for reducing the risk of complications in relation to complex medical interventions as well as to reduce spread of (multi-drug) resistant bacterial strains.
If one could propose a completely new class of antimicrobial compounds, this problem would be circumvented, thus creating very significant added value, both economic as well as societal, that others cannot easily copy.
Our one health approach
Madam Therapeutics follows a ‘One Health’ approach for development of its products. Many of the same microbes infect animals and humans, as they share the ecosystems they live in.
Unfortunately, there is significant potential for emergence of antibiotic-resistant organisms in animal and human populations from the widespread use of antibiotics in food animals.
A One Health approach – New antimicrobial agents that are really different from human antibiotics is therefore extremely relevant for combating antibiotic resistance.
Madam Therapeutics has a adopted the One Health philosophy via a dedicated development program of our SAAP-based platform for human health and animal health. The lead molecule for the human health is called SAAP-148 and the lead molecule for the animal health is called P10.
P10 and related peptides have the same benefits for the animal health as our lead peptide family of SAAP-148 for human health . As P10 is derived from a different family as our lead molecules for human health, there is no concern for cross-resistance. Yet P10 also carries all the significant advantages over traditional antibiotics that our human leads have.