PREP: Pandemic and Resistance Emergency Preparedness
Preventing the Next Global Pandemic - Tackling AMR

As a leading company in anti-infective drug development, AiCuris was always focused on indications with a high medical need such as the prophylactic treatment of human cytomegalovirus (HCMV) in transplant patients, genital herpes caused by herpes simplex virus (HSV), the cure of chronic hepatitis B as well as adenovirus infections. In 2017, together with MSD, the company successfully launched its first product for the prevention of HCVM infections in patients undergoing allogenic stem cell transplantations.

With this newly introduced PREP initiative we are resolutely expanding our focus into the area of pandemic and resistance preparedness, addressing what we believe will be the biggest threats for global healthcare systems going forward. The need to be prepared for future pandemics and antimicrobial resistance is what the current pandemic has taught us. As a proven expert in anti-infective drug development with deep experience in bringing products through clinical development and to the market, we at AiCuris feel best positioned and are highly committed to contribute and work on Pandemic and Resistance Emergency Preparedness.

AiCuris – Active in the fight against Corona

The global COVID -19 pandemic, caused by a newly discovered coronavirus, SARS-CoV-2, has taught us that we must prepare for the worst in order to prevent future pandemics. But, of the many viruses known to infect humans, what makes SARS-CoV-2, which has caused the worst pandemic in a century, so dangerous?

First of all - humans have never been in contact with the virus before, meaning that absolutely no one has immunity. Secondly, it infects the upper respiratory system and as influenza spreads easily from person to person through respiratory droplets via coughs, sneezes, and even through loud talking. Infected people could also unknowingly spread the virus days before they begin to experience symptoms themselves since the incubation period of the virus could last up to 14 days. Moreover, asymptomatic carriers could even spread the diseases without ever experiencing symptoms. In its most severe form, COVID-19 manifests in the lower respiratory tract, the bronchial tubes and the lung, and can lead to acute respiratory distress syndrome (ARDS) and death.

AiCuris stepped into the fight against Corona and COVID-19 early on, as we felt that as part of the biotech and pharmaceutical industry, we have a great societal responsibility to take up the cause. In April 2020, we therefore decided to provide immediate unbureaucratic support locally and also started to evaluate suitable drug candidates from our portfolio to treat SARS-CoV-2 infections. Locally, we joined a consortium to support infrastructures and clinics in the region with our expertise, network and laboratories and we also supported the North Rhine-Westphalia (NRW) Health Minister in the area of diagnostics to provide urgently needed testing capacity.

However, AiCuris strongly believes, fighting COVID-19 alone is not enough – evidence has shown that the next healthcare crisis could lie around the corner.

Looking beyond Covid-19

It is fair to conclude that the global COVID-19 pandemic has caught society on a whole on the back foot. As we seek to combat this novel virus and have to adjust to new procedures and international norms, we are now innately aware of the importance of preparing for the worst in order to prevent future pandemics.

While scientists are working to understand and control the COVID-19 pandemic, it is also crucial to prepare for potential future, viral pandemics but also on secondary bacterial infections and the resulting impact this could have in antimicrobial resistance (AMR).

AMR, an even larger threat still hidden behind the current SARS-CoV-2 outbreak, is already killing hundreds of thousands of people around the world.

According to the “Antibiotic Resistance Threats 2019” report, published by the U.S. Centers for Disease Control and Prevention (CDC), more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result - more than 70 percent of the bacteria that cause these infections are resistant to at least one of the antibiotics commonly used to treat them.

It has therefore to be assumed that antimicrobial resistance (AMR) or superbugs could lead to the next global emergency as their resistance to currently available antibiotics puts all patients at risk, whether they are receiving care for minor illnesses or need to undergo major surgeries.

AiCuris is committed to preparing for the next global emergencies by investing time, expertise and financial resources in the cause. For this reason, AiCuris introduces its PREP campaign taking a four-pillar approach to Pandemic and Resistance Emergency Preparedness:

I.   Expand the development of AIC649 as a broad-acting first-line pandemic therapy,
II.  Drive development in resistant breaking antibiotics based on novel approaches
III. Launch AiCubator - a new way of collaboration in the anti-infective area and
IV. Pursue an active licensing strategy for late pre-clinical and early clinical projects

10 reasons to prepare now to tackle AMR and prevent future pandemics:

  1. Now we definitely know! Covid-19 taught us insistently that we need to prepare for the worst in order to prevent future pandemics particularly those caused by superbugs and emerging zoonoses.

  2. Only if we have a better understanding of the pathogens and potential pathways to counteract them, can we be prepared for and prevent future crisis.

  3. Controlling new or resistant infectious agents as early as possible is most important to save thousands or even millions of lives. For that, we need a combination of worldwide surveillance, modern vaccines and broad-acting therapeutics fighting the pathogens and strengthening the human immune system.

  4. We are currently learning how necessary it is to act early to sustain the global economy and societal functionality: According to The World Bank the baseline forecast envisions a 5.2 percent contraction in global GDP in 2020, the deepest global recession in decades. According to Asian Development Bank, the coronavirus pandemic could cost the global economy between $5.8tn and $8.8tn.

  5. Investing now in new anti-infective treatments – even in the absence of a currently existing business model - is the only way to avoid worldwide emergencies in the future. We do not wait for a fire before establishing fire protection measures. Why should we wait in case of life-threatening infections?

  6. Next to pandemics we must urgently prepare for rising resistance issues especially in the field of antimicrobial resistance (AMR). 10 million deaths globally are expected per year by 2050 under the most alarming scenario if no action is taken[1,2,3]. While lower numbers of these additional deaths would occur in North America or Europe, largest numbers are expected in Africa and Asia.

  7. We must limit the spread of antimicrobial resistance now and treat it as the emergency it is: In the WHO 2017 priority pathogens list[4], 12 classes of bacteria plus tuberculosis are listed as posing increasing risk to human health because they are resistant to most existing treatments.

  8. Every single year, bacteria become more widespread, more deadly, and far more difficult to treat – at the same time, the number of antibacterial treatments to manage those infections have barely increased. Therefore, AMR threatens the effective prevention and control of bacterial infections jeopardizing the success of e.g. major surgeries and cancer treatments, leading to prolonged treatment times, higher mortality, high burden on health systems and high economic impact

  9. The pipeline of drugs to manage deadly AMR infections is virtually dry. In 2016 some 100 pharma companies, with almost half of the companies that signed the declaration and researched antibiotics are no longer active in this field jointly created the "AMR Industry Alliance" to invest in antibiotics research[5, 6]. Since then, only 4 antibiotics effective against WHO critical threat pathogen got approval according to the global research and public policy organization, PEW, as of April 2020.

  10. If we decide against the widespread use of new resistance-breaking therapies to avoid the emergence of new resistance, then society must be prepared to pay adequate prices for salvage therapies. Currently, on the one hand we see restrictive use of innovative therapies in combination with low prices. On the other hand, extremely high development costs result in enormous losses and bankruptcies of “successful” innovators. To overcome this market failure, it is essential to foster new reimbursement approaches. Saving lives must not be prevented by missing business models.

The next pandemic and AMR emergency should not come as a surprise! We already know today that this is an imminent future threat.

This is not the time to wait. This is not the time for discussion. This is the time to act!

AiCuris is committed to work on Pandemic and Resistance Emergency Preparedness!

Time to act now!

Learn more on the AiCuris PREP campaign taking a four-pillar approach to Pandemic and Resistance Emergency Preparedness:

References and additional information:

  1. UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance, No Time to Wait: Securing the future from drug-resistant infections, April 2019
  2. U.S. Centers for Disease Control and Prevention (CDC), Antibiotic Resistance Threats 2019
  3. Jim O’Neill, The Review on Antimicrobial Resistance - Tackling a crisis for the health and wealth of nations, December 2014
  4. WHO, Global priority list of antibiotic-resistance bacteria to guide research, discovery, and development of new antibiotics,
  5. amr industry alliance
  6. NDR investigation: Pharmaceutical companies pulling out of antibiotic research, September 2019

If you have further questions regarding partnering of our projects please contact:

 
 
Dr. Igor Orshanskiy
Associate Director
Business Development &
Alliance Management
 
AiCuris Anti-infective Cures GmbH
Friedrich-Ebert-Str. 475
42117 Wuppertal
 
Phone: +49 (0)202 317 63 - 0
Fax: +49 (0)202 317 63 - 1177
E-Mail: business@aicuris.com