04 May 2020 – Independent review supports the potential of XF-73

Destiny Pharma plc
(“Destiny Pharma” or the “Company”)

Independent expert review of data supports the potential of XF-73 to address antimicrobial resistance

Publication in peer-reviewed journal ‘suggests that Staphylococcus aureus, including MRSA, has low potential to evolve resistance to XF-73 relative to antibiotics’

Brighton, United Kingdom – 4 May 2020 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs that address clear commercial opportunities as well as the global problem of antimicrobial resistance (AMR), notes the publication of a new paper in Trends in Microbiology, entitled: “Assessing the potential for Staphylococcus aureus to evolve resistance to XF-73”1. The author, from the University of Oxford, concludes that data published to date support the unique target profile of XF-73 and its potential to address the threat of AMR.

The review looked at data from a number of established microbiology models that were used to evaluate the action of XF-73 in killing S. aureus that were carried out previously by Destiny Pharma. The paper concluded that the available evidence suggests that S. aureus has low potential to evolve resistance to XF-73 relative to antibiotics. This conclusion supports the company’s own view that XF-73 has a unique resistance profile due to its novel, ultra-fast mechanism of action that is a key advantage compared to typical antibiotics.

Professor Maclean, the paper’s author, is a Wellcome Trust Senior Research Fellow and Professor of Evolution and Microbiology at the University of Oxford. Research in the MacLean lab is focused on understanding the evolutionary biology of antibiotic resistance in pathogenic bacteria such as S. aureus.

Neil Clark, CEO of Destiny Pharma, commented:
“One of the key attributes of our lead drug candidate, XF-73, and our XF platform is the unique “no or low” resistance profile when they are used to kill dangerous bacteria. This new review supports this key component of our target product profile for XF-73.

There remains a global need for new anti-infective drugs targeted at the prevention and treatment of serious infections. This has been highlighted further by the serious secondary bacterial infections complicating treatment in many COVID-19 patients. New drugs must also
address the challenge of AMR and we believe that our XF platform does just that. We look forward to reporting headline data from our current phase 2b study that is evaluating the potential of XF-73 nasal gel in the prevention of post-surgical infections.”

Destiny Pharma is initially developing a nasal gel formulation of XF-73 as a novel therapy to prevent post-surgical infection, including those from methicillin resistant S. aureus (MRSA), as nasal carriage is the source of >80% of S. aureus/MRSA post-surgical bacterial infections.
The Company is currently conducting a 200 patient multi-centre, randomised, blinded, placebo-controlled phase 2b study of a single concentration of XF-73 nasal gel. This is to assess the anti-staphylococcal effect of XF-73 on S. aureus nasal carriage in US and European patients scheduled for cardiac surgical procedures deemed to be at high risk of post-operative S. aureus infection.

The global threat of AMR
Infections caused by Antibiotic Resistant (AR) strains of bacteria continue to rise at an alarming rate. They pose a threat to humanity. Antibiotics represent the foundation for all modern medicine. However, this has been taken for granted and now we find that bacteria have become resistant to almost every antibiotic developed by man and the US CDC estimate that nearly 3 million infections a year in the US alone are caused by AMR strains2. These AMR bacteria, dubbed by the media as ‘Superbugs’, are harder to treat, cause greater mortality and additional cost to the healthcare system.

Unless action is taken to address this huge global issue, the Independent Review on antimicrobial resistance (Lord O’Neill) estimates that it will cost the world an additional 10 million lives a year by 2050, more than the number of people currently dying from cancer annually. It will also have a cumulative cost of $100 trillion, more than one and a half times annual world GDP today.

New antibiotics will ‘buy time’, however perhaps more importantly we need to adopt strategies that may reduce the emergence of AR strains. At Destiny Pharma, one such strategy is being developed in the form of a new group of antibacterial drugs ‘the XF Drug platform’, who’s novel, ultra-rapid mechanism endows them with the extraordinary ability to reduce the chance of bacteria becoming resistant to their action.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

finnCap Ltd (Nominated Adviser and Joint Broker)
Geoff Nash /Anthony Adams, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0)20 3705 9321

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines from its XF Platform that represent a new approach to the treatment of infectious disease. The company’s lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed for the prevention and treatment of life-threatening infections caused by antibiotic‑resistant bacteria, often referred to as “superbugs”. Tackling anti-microbial resistance has become a global imperative recognised by the World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com

About XF-73
XF-73 is a synthetic antimicrobial active against all tested Staphylococcus aureus strains, including drug‑resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through seven successful Phase 1/2a clinical trials showing it is safe and delivers a rapid antibacterial action. In standard microbiology studies XF drugs have demonstrated a unique no/low resistance profile that means that XF compounds have the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility.

XF-73 is being studied for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.

1. R. Craig Maclean Trends in Microbiology DOI: https://doi.org/10.1016/j.tim.2020.03.011
2. https://www.cdc.gov/drugresistance/biggest-threats.html