As 2021 gets underway there is still much to do to make the world more resilient against a range of global health threats. The ongoing pandemic has highlighted dramatically the impact of an uncontrollable viral infection and also brought focus to another significant infection threat caused by Anti-Microbial Resistance (AMR) and the rise of the superbug. AMR kills at least 750,000 people worldwide annually and could lead to as many as 10 million deaths annually by 2050. Governments across the world are worried and AMR is regularly on the agenda at WHO, G20, G7 and COP26 meetings as a global threat.
Figures from the Pew Trust in 2019 show only 41 new antibiotics with the potential to treat serious bacterial infections in clinical development. This is a worryingly small pipeline compared to a 2020 Cancer Research Institute estimate of over 4,500 immuno-oncology agents in development. It is important to note that many cancer treatments and surgeries ALSO require high quality infection prevention as any infections will delay or even prevent oncology treatment regimens and every month lost is critical. Infection prevention and treatment is therefore a key component of the successful management of a wide range of other illnesses and disease. The clinical need is clear but help is urgently needed to expand the global anti-infective drug pipeline.
According to the BEAM alliance (Biotech companies from Europe innovating in Anti-Microbial resistance research) SMEs, such as Destiny Pharma, are by far the largest contributors to the AMR drug pipeline. The lack of large pharma participation is the main reason for the need of the various supporting mechanisms outlined in this article.
We talked to CEO Neil Clark and CSO Dr Bill Love from Europe’s leading anti-infectives biotech company Destiny Pharma, for insights into how the makers and influencers of health policy could fuel a renaissance in drug development to fight bacterial and fungal infections, and to hear what Destiny Pharma’s call to arms is to combat AMR.
Pull and push harder!
Many supporting mechanisms are in play and they can roughly be divided into ‘Pull and Push’ incentives. They are all aiming to create a broader anti-infective pipeline and a more predictable market with acceptable returns for the investment required. The ‘Push’ programmes are the more familiar non-dilutive financial approaches, such as Government grants, including BARDA and CARB-X in the US and the UK’s Wellcome Trust and Innovate UK. There are also now specific investment funds such as Novo’s REPAIR Impact Fund and the recently formed $1 billion AMR Action Fund that are investing in research and clinical trials that address the challenge of AMR. ‘Push’ funding is often targeted at the toughest bacteria where treatment options are sparce and are designed to widen the research field so more novel molecules can enter the drug discovery funnel and eventually clinical development. But these ‘Push’ initiatives are not enough on their own and additional support is needed to underpin the commercial opportunity for the investors in these research projects.
The extra help has started to arrive in the form of creative “Pull” incentives driven by government medical advisors such as Dame Sally Davies in the UK alongside regulators, the WHO, industry groups and policymakers. These discussions have developed the concept of clear ‘Pull’ incentives, to provide a vitally important commercial end game alongside the earlier stage support for research. The most advanced policy is in the UK which has recently set up a novel subscription payment model, which ‘de-couples’ payment from volume of use thereby setting out guaranteed sales volumes for selected anti- infection drugs. This structured arrangement is a similar concept to what has been rolled out at breakneck speed to support the development and advance purchases of COVID-19 vaccines by governments around the world.
The UK has recently chosen the first two novel anti-infectives under this scheme. Other countries in Europe are also reviewing the UK’s approach and developing their own versions of this system. Giving a clearer commercial market and financial return should enable companies and investors to get more comfort on the potential for a return on the investment needed in the expensive research and development phase.
Destiny Pharma supports such novel approaches but has been careful in building its own drug pipeline to select programs that have clear advantages to the competition (where it exists) and can stand on their own feet with clear commercial markets and are therefore less reliant on such “pull” incentives. The company’s pipeline also has the advantage of focusing on prevention as being more cost effective than cure.
Pasteur support from regulators in US
The US FDA and government healthcare regulators have shown real leadership for many years to support innovation and the development of new anti-infectives. The most recent draft legislation is the PASTEUR Act (Pioneering Antimicrobial Subscriptions to End Upsurging Resistance). This is designed to encourage innovation targeting the most threatening infections and ensure domestic (US) availability. Other well established regulatory support in the US includes Fast Track or Breakthrough status, and extended market protection, such as the FDA’s Qualifying Infectious Disease Product award, which was awarded to Destiny Pharma’s product, XF-73, a nasal gel for the prevention of post-surgical staphylococcal aureus infection.
Friendly bacteria to the rescue?
Another approach to combat AMR is to develop infection prevention treatments that avoid drugs and harness the naturally occurring benefits of the human microbiome and the benefits of external, naturally occurring bacteria. This is a rapidly developing area of research and drug development and companies are building on the established benefits of a healthy gut microbiome to examine the microbiome’s impact on other conditions including cancer and neurological disorders. Destiny Pharma has added two such ‘biotherapeutic’ programs to its pipeline in 2020; NTCD-M3 is aimed at preventing infections caused by toxic strains of C. difficile responsible for many hospital-acquired infections and deaths. Destiny Pharma is also developing an easy to use nasal biotherapeutic product, SPOR-COV, with the potential for rapid protective action against COVID-19 and influenza.
The COVID-19 crisis reminds us how underprepared the world is to detect and respond to emerging infectious disease. Significant further efforts from the pharma and biotech industry, the investment community and the makers of health policy are needed to make the world more resilient against a range of global health threats caused by infectious disease.
Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which is in a Phase 2b clinical trial targeting the prevention of post-surgical Staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.
For further information, please visit: https://www.destinypharma.com