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Rethinking our approach to infectious disease preparedness

The importance of long-term strategic investment to prepare for the next threat that emerges

We are living through the worst pandemic in memory and even though world health leaders warned it was possible, the state of our collective readiness has been painfully lacking.

Everything that’s happened has accelerate the need for pandemic preparedness beyond the current COVID-19 outbreak. Clearly, the pace at which a virus can emerge and spread around the world easily beats the many years needed to invent and develop new drugs, and even outstrips our ability to respond rapidly to create and test effective vaccines.

So we need long-term strategic investment so that we have therapies and vaccines under development – and the infrastructure to support them, from governments and the private sector – in the vital first few months of the next threat emerging.

Effective therapeutics and vaccines

Of course there are measures we can take to try to minimise the spread of disease such as increasing personal hygiene, self-isolating, maintaining social distancing and imposing lockdowns. But we now know that these interventions come at a huge cost to the national economy and well-being of individuals so, in the end, we need a timely supply of new, effective therapeutics and vaccines.

Bill Gates made this point long before COVID-19 emerged from Wuhan. The Microsoft founder put it pointedly in a March 2015 TED talk entitled ‘The next outbreak? We’re not ready’.

Gates said: “Today, the greatest risk of global catastrophe... looks like this... a highly infectious virus. Not missiles, but microbes.” Gates also called for rapid development of diagnostics and vaccines, “ideally one that confers protection within hours rather than days or weeks”.

Antimicrobial resistance

There is a second pandemic that we have to deal with – the rising tide of antimicrobial resistance, where bacteria are becoming resistant to the antibiotics we routinely use to treat patients suffering from life-threatening infections, such as pneumonia or sepsis. And here too, we have an inadequate supply of new drugs in the pipeline to defeat microbes that are evolving and spreading round the world.

Having spent a decade working on the AMR threat to global health, John Rex, the distinguished physician and drug developer, uses the fire service analogy: we do not wait for a house fire before getting a fire extinguisher.

There are now disturbing links emerging between coronavirus and AMR. The SARS-Cov-2 virus weakens the body, making it easier for bacterial infections to take hold. According to a paper in The Lancet, early research has found that nearly 15% of all COVID-19 patients acquire deadly secondary bacterial infections.

These bugs can cause or worsen a patient’s pneumonia and lead to septic shock, a life- threatening complication. Furthermore, public health authorities and scientists suggest that, out of all the individuals who died from COVID-19, as many as half were afflicted with these secondary infections. Among these opportunistic bacteria are drug-resistant superbugs.

How can we start to make progress? First we need to acknowledge and remedy the fundamental weaknesses in the way our infectious disease ecosystem currently functions.

Prioritising research

With notable exceptions, for many global pharmaceutical companies, infectious disease R&D simply hasn’t been a priority for their investment decisions because of the poor financial returns that are available. And the knock-on consequence of this is that fewer biotech companies (and their investors) are attracted to the sector, as there are limited opportunities to sell or license their innovations to major pharma acquirers.

So in summary, to date there have been systemic issues with reimbursement, funding and the level of deal-making in the infectious disease eco-system, leaving a fragmented and under- funded baseline that has been found wanting.

Oncology, by comparison, is a much more dynamic and productive therapeutic area. There is a clear pathway to reimbursement, with the metrics for paying for cancer treatments well understood. In turn, investment is forthcoming because there’s a healthy level of transactions.

Deals keep the wheels of R&D turning, allowing early stage seed investors to get their money back when another business acquires that intellectual property or buys the company. That flow of transactions is essential and it’s just not been happening on the required scale to maintain a healthy pipeline of new anti-infective drugs.

Generating a return

We need to see more investment and consolidation to build biotech companies with critical mass and longer cash runways to drive their products through development into clinical trials. And we need to see more commercial deals to reinvigorate the ecosystem. In other therapeutic areas, there is an opportunity for early-stage biotech investors to generate a return from an exit to a larger pharma company.

The chances of a small company taking a new drug all the way to market after 15-20 years of work, launching its own product and marketing it globally is, in my view, virtually non-existent, but this has been the model in the AMR sector for the past few years.

Achaogen and Aradigm filed for bankruptcy in 2019, and Melinta did the same at the start of 2020, despite heavy investment from the US Biomedical Advanced Research and Development Authority (BARDA). Commendably, BARDA provided funding to bridge the clinical development gap as there were no big pharma companies willing to take on those assets.

The broken reimbursement model that provided limited reward for their efforts, along with the cost of late stage clinical trials and commercialising the products proved to be too much and they ran out of cash. There are now some serious attempts at reforming how new infectious disease treatments are rewarded.

This summer, the UK began a pioneering scheme to redesign the antibiotics market altogether. NHS England will now pay pharma companies a guaranteed amount for access to new drugs to treat resistant infections for up to ten years, a reward potentially totalling £100m.

This exciting new model breaks the link where payment is made on the volume of drug sold – and will incentivise drug developers and their investors to bring innovative products to market. The same approach is currently proposed in a bill before the US Congress – The PASTEUR Act – that proposed payments to drug developers of between $500m to $3bn to deliver vital new treatments for seriously ill patients.

Use only when needed

These schemes address another vital element of AMR – that we need to use new drugs sparingly so as not to drive further evolution of the microbes to become resistant to the new drugs themselves. Both the UK and US models treat access to novel antibiotic medicines like a Netflix subscription: for a fixed price paid to a biotech company each year, the healthcare system could use as many – or as few – doses as it needs.

If doctors correctly use an antibiotic sparingly, the drug company still profits and the fire extinguisher is safely on the shelf ready to be used when needed. My own organisation is committed to playing its part in rebuilding the infectious disease drug pipeline.

In 2016 we launched as The AMR Centre, with a sole focus on developing new treatments for drug-resistant bacterial infections, and now have seven exciting programmes in our portfolio. With our relaunch as Infex Therapeutics this year, we are demonstrating an expanded focus to include viral as well as bacterial infections.

We are using our drug development capability and expertise to target a wider range of World Health Organization critical-priority viral and microbial pathogens, including coronaviruses. Over the past year, we have identified and acquired promising technology, as well as initiating our own in-house R&D programmes. We are also actively looking for other new opportunities in antiviral therapeutics and AMR drugs over the next year.

The ongoing COVID-19 pandemic has demonstrated the huge cost to our economies and healthcare systems of failing to properly prepare for infectious disease pandemics.

We now need to start to focus on what we need to do to prepare for the future, and create a positive innovation, funding and regulatory agenda for infectious disease preparedness.

Let’s hope that COVID-19 will be a catalyst to reinvigorate the infectious disease ecosystem as a whole.

Peter Jackson, executive director, Infex Therapeutics (previously the AMR Centre)

24th November 2020

Peter Jackson, executive director, Infex Therapeutics (previously the AMR Centre)

24th November 2020

From: Healthcare

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