17 Sep 2020 – Update on Phase 2b clinical study of lead asset XF-73 in the prevention of post-surgical infections

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

Update on Phase 2b clinical study of lead asset XF-73 in the prevention of post-surgical infections

Recruitment on track to complete by year-end and report results in early 2021

Brighton, United Kingdom – 17 September 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life threatening infections today announces an update on it its XF-73 Phase 2b clinical study with 88 patients out of the target of 125 now recruited.  There is good momentum in patient recruitment which we expect to continue into the Autumn.

The Phase 2b clinical study is recruiting patients undergoing open heart surgery in United States and Europe. Barring any further impact from COVID-19 the study is on plan to complete recruitment by the end of 2020 and report results in Q1 2021.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to report a  significant increase in the screening and recruitment of patients in our lead clinical study testing XF-73 as a novel product preventing the incidence of post-surgical infections such as MRSA. In the past few months we have agreed a protocol amendment with the FDA and also reported excellent interim safety data and are looking forward to completing recruitment and reporting the results.”

Details of Phase 2b Study

The ongoing Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcal aureus nasal carriage in 125 patients scheduled for open heart surgery

The Phase 2b study design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark, Shabnam Bashir, Manel Mateus
Tel: +44 (0) 203 174 1789
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines that can prevent life threatening infections.  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 Organization (WHO) and the United Nations, as well as the G7 and the G20 countries.  Destiny Pharma is also collaborating with SporeGen® to co-develop a novel, preventative product for COVID-19. For further information, please visit https://www.destinypharma.com

07 Sep 2020 – Destiny Pharma and SporeGen® announce collaboration and Innovate UK grant award to co-develop novel, preventative treatment for COVID-19

Destiny Pharma and SporeGen® announce collaboration and Innovate UK grant award to co-develop novel, preventative treatment for COVID-19

  • SPOR-COV prophylactic approach targets the innate immune system with potential to develop COVID-19 protection within a few days of treatment
  • Innovate UK grant of £800,000 to support SPOR-COV™ programme over the next 18 months
  • Expands Destiny Pharma’s novel pipeline targeted at preventing infections

Brighton, United Kingdom – 7 September 2020

Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR), today announces that it has entered into a collaboration agreement with SporeGen Limited (“SporeGen”), a UK biotechnology company working exclusively on Bacillus and its applications, to co-develop SporeGen’s SPOR-COV product as a novel, preventive treatment for COVID-19.

Under the agreement, the parties will share any costs and commercial returns from SPOR-COV and plan to complete a pre-clinical programme with the aim of being ready to enter the first human clinical trials within 18 months. Destiny Pharma’s expertise in pre-clinical and clinical drug development will be combined with SporeGen’s world leading understanding of Bacillus bacterial spores to progress the SPOR‑COV project.

The SPOR‑COV product consists of a proprietary formulation of Bacillus bacteria that will be administered nasally as a spray. SPOR-COV has already been shown by SporeGen to provide complete (100%) protection in preclinical models of influenza virus. SporeGen has IP protection supporting the SPOR‑COV approach and this will be expanded during the project.

SPOR-COV is different to vaccines in that it utilises the innate immune system with the aim of developing COVID-19 protection a few days after dosing. As an “easy to use” first line of defence, it has the potential to reduce COVID-19 infection rates and transmission significantly. The final SPOR-COV product is planned to be straightforward to produce at high volumes and at low cost. Additional attributes are that it could be stockpiled almost indefinitely without the need for cold chain refrigeration as it is a very stable product. It could be made available globally as a cost-effective measure in the fight against COVID-19 as well as new COVID strains and other respiratory viral infections.

£800,000 grant from Innovate UK (IUK) to support SPOR-COV™ preclinical programme

Destiny Pharma and SporeGen are also very pleased to announce that IUK has awarded a grant of £800,000 to fund the majority of the £1 million cost of the initial SPOR-COV programme. The preclinical efficacy work will be undertaken in collaboration with Professor Aras Kadioglu, at University of Liverpool who is Professor of Bacterial Pathogenesis in the Department of Clinical Infection, Microbiology & Immunology,  where he heads the Bacterial Pathogenesis and Immunity group and is a leading expert in respiratory infection models and host immunity to infection. The manufacturing and formulation development work will be carried out by HURO, an experienced manufacturer of bacterial product formulations based in Vietnam and part of PAN Group. The plan is to complete the required pre-clinical safety and efficacy studies and also develop the manufacturing process in the next 18 months and be ready to commence the first human clinical studies thereafter.

Professor Simon Cutting, Chief Executive of SporeGen, said: “The SPOR-COV platform has already been shown to be effective against pandemic flu by targeting the innate immune system. As such, SPOR-COV potentially has value as a universal system for combatting other viral diseases such as COVID-19. If successful, we foresee a novel approach against COVID-19 and for future, similar pandemics. The SPOR-COV approach, unlike traditional vaccination, focuses on innate immunity and may not be impaired by new mutational variants. A further attribute of SPOR-COV is that it can be produced and stockpiled with ease and does not require a cold-chain. Prima facie our approach is simple and offers a potential new approach in the fight against one of the most serious diseases to afflict mankind”.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are excited to announce the collaboration with SporeGen to co-develop their SPOR-COV product to prevent COVID-19 infections and the concurrent award of significant grant funding from Innovate UK. We are also pleased to be working with Professor Kadioglu at the University of Liverpool who has world class virology expertise. Destiny Pharma is committed to building a novel pipeline targeted at preventing infections and is very pleased to now be working with partners on the SPOR-COV project alongside our existing in-house XF platform.  The ongoing coronavirus pandemic has highlighted powerfully the need for innovation in developing new treatments to prevent and manage both viral and bacterial infections and Destiny Pharma remains committed to developing cost-effective products that meet this medical need”.

 ENDS

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

For further information, please contact:

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

SporeGen Limited
Professor Simon Cutting CEO
Kim Oanh Nguyen, COO
s.cutting@sporegen.com
+44-(0)7691 2090/+44-(0)7900 408043

Optimum Strategic Communications
Mary Clark, Shabnam Bashir, Manel Mateus
Tel: +44 (0) 203 174 1789
Email: DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development 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 SporeGen
SporeGen Limited was founded in 2012 as a biotech start up at the Royal Holloway University of London and was spun-out in 2017. The company is now situated at the London Bioscience Innovation Centre in central London. The company’s focus has been on development of novel prophylactic and therapeutic products including vaccines. The company has worked extensively with spores (Bacillus/Clostridia) and were the first to use spores as vaccine delivery vehicles including coordination of a Phase 1 study of a mucosal vaccine. The company has licensed a number of interventions to companies including large global biotechnology companies. The company has a number of pipeline products including an oral vaccine to C. difficile infection that has been taken to phase 1 clinical studies. The company was founded by Professor Simon Cutting who is a leading expert in the bacteria Bacillus and its potential application as a medical treatment in human health.  Professor Cutting is a bacterial geneticist with over 35 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. After spending 7 years in the renowned laboratory of Professor Richard Losick at Harvard University Biological Laboratories (USA) he was as an Assistant Professor at the University of Pennsylvania Medical School in Philadelphia. He returned to the UK in 1996 where he is a Professor at the Royal Holloway, University of London. For further information please visit http://www.sporegen.com

About Innovate UK
Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. Innovate UK connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth.

Innovate UK fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit www.innovateuk.ukri.org

UKRI Ideas to Address COVID-19
This UKRI (United Kingdom Research and Innovation) competition opened in March 2020 as a call for short-term projects addressing and mitigating the health, social, economic, cultural and environmental impacts of the COVID-19 outbreak across areas within UKRI’s remit.

 

11 Aug 2020 – Positive interim safety review of Phase 2b clinical trial of lead asset XF-73 in the prevention of post-surgical bacterial infections

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

Positive interim safety review of Phase 2b clinical trial of lead asset XF-73 in the prevention of post-surgical bacterial infections

Brighton, United Kingdom – 11 August 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel treatments for hospital infections that address the global challenge of antimicrobial resistance (AMR), announces a positive interim safety review has been completed by an Independent Data Monitoring Committee (IDMC) of the Company’s ongoing Phase 2b study of its lead asset XF-73 in the prevention of post-surgical bacterial infections.

Further to the announcement on 27 July 2020 detailing a US Food and Drug Administration approved clinical protocol amendment to the Phase 2b study, the IDMC has reviewed safety data from the first 75 cardiac surgery patients who have completed study treatment. Adverse event data, including safety laboratory results, incidence of post-operative infections, ear, nose, and throat examinations, as well as sense of smell tests were reviewed by the IDMC. Based on their evaluation, the IDMC has recommended that the study can continue without any modifications to the protocol. Recruitment into the study remains on track to complete by the end of 2020.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“We are very pleased the IDMC has concluded that there are no safety concerns in the patients treated in the Phase 2b study to date and that the study can continue as planned. This is consistent with our previous experience of testing XF-73 in several clinical studies. We believe XF-73 nasal gel has the potential to become a well-tolerated, novel and effective treatment for the prevention of post-surgical Staphylococcal infections and represents a significant commercial opportunity. We are now two thirds of the way through the study and look forward to completing recruitment by the end of 2020.”

The ongoing Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcal aureus nasal carriage in 125 patients scheduled for surgical procedures deemed to be at high risk of post-operative Staphylococcal aureus infection.

The Phase 2b study design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

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 Advisor Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development 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

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

10 June 2020 – Result of Annual General Meeting

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

Result of Annual General Meeting

Brighton, United Kingdom – 10 June 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR),  announces that all resolutions proposed to shareholders at the closed Annual General Meeting held earlier today were duly passed.

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 Advisor Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development 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

09 June 2020 – Grant awarded for Cardiff University collaboration

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

Destiny Pharma awarded grant to fund collaboration with Cardiff University targeting fungal infections

Collaboration will test antimicrobial candidates from the Company’s XF drug platform against oral fungal infections.

Brighton, United Kingdom – 9 June 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR), today announces it has been jointly awarded a National Biofilms Innovation Centre (NBIC) grant to fund a research collaboration with Cardiff University. The project will establish the potential of three of the Company’s proprietary XF drug compounds, DPD‑207, XF-70 and XF-73 as novel treatments for clinically important fungal infections in mucosal mouth models of disease. Financial terms of the collaboration have not been disclosed.

Neil Clark, Chief Executive Officer of Destiny Pharma, added:
We are very pleased to collaborate with the expert team at Cardiff University supported by NBIC. Our XF drugs have already shown activity against bacteria packed in biofilm communities that represent a significant barrier to antimicrobial treatments. This new collaboration may help us identify additional clinical candidates from our XF platform for oral indications related to biofilms in a billion-dollar market. This is also our first research project targeting fungal infections and joins our other four existing research collaborations funded by approximately £2m of grant awards. The project will explore further the potential of our lead drug, XF-73 that is currently in a phase 2b study,  evaluating its potential for the prevention of post-surgical infections.”

Professor David Williams, Professor in the College of Biomedical and Life Sciences at Cardiff University School of Dentistry commented:
“Oral candidoses are prevalent and frequently recurrent infections that typically manifest in debilitated individuals. Given the limited number of antifungal agents and the increasing level of resistance exhibited by Candida species, it is essential that new and effective antifungals are developed. My research team in the School of Dentistry at Cardiff University, are delighted to receive the support of the National Biofilms Innovation Centre (NBIC) which facilitates this exciting collaboration with Destiny Pharma in the investigation their XF drug platform for combatting Candida biofilms”.

Oral fungal biofilms are responsible for a significant number of serious oral infections, but successful treatment is hindered by biofilm resistance and a limited number of effective antifungal drugs. This project will evaluate the XF drug candidates in combatting Candida biofilms and their infection risk using Cardiff’s specialised oral mucosal models.

Oral candidosis occurs in an estimated 2 million people worldwide including approximately ~90% of HIV/AIDS patients, people taking inhaled steroids for asthma, head and neck cancer patients undergoing radiotherapy and some leukaemia and transplant patients. Candida infection of the oesophagus affects an estimated ~1.3 million people and the global oral candidosis market is expected to reach US$ 9.5 billion by 2023.1

NBIC’s stated aim is to establish a network of research and innovation capacity catalysing collaborations with industry in the study of biofilms to achieve breakthrough innovation. This is the third grant award from NBIC that Destiny Pharma has received.

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 Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development 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 The National Biofilms Innovation Centre (NBIC)
NBIC is an Innovation Knowledge Centre (IKC) jointly funded by the BBSRC, Innovate UK, and the Hartree Centre. NBIC aims to connect scientists specialising in Biofilms across the UK, and to provide a mechanism for industrial partners to explore their unmet needs with our researchers. With road mapping sessions and conferences, NBIC aims to facilitate the exchange of problems, solutions and ideas in the biofilms sector. Through PhD and Post-Doc programs, NBIC nurtures researchers to grow their expertise. NBIC also provides entrepreneur training to its researchers to help them better understand the commercial environment and to encourage the start-up of Micro and SME businesses.

1: MRFR, Pharma and 3008-HCR, 2020. Oral Thrush Market Research Report- Forecast To 2023 | MRFR. [online] Marketresearchfuture.com. Available at: https://www.marketresearchfuture.com/reports/oral-thrush-market-4417

12 May 2020 – Posting of Annual Report and Notice of AGM

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

Posting of Annual Report and Accounts, and Notice of AGM

Brighton, United Kingdom – 12 May 2020 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR), announces that the following documents are now available on the Company’s website at www.destinypharma.com

Printed copies of both documents will be posted to shareholders today.

To comply with the UK Government’s Stay at Home measures, shareholders will not be allowed to attend the meeting in person. Shareholders are strongly encouraged to therefore submit their votes, in respect of all matters of business, via proxy as early as possible. They should appoint the Chairman of the meeting as their proxy. If the situation changes then shareholders will be notified via the Company’s website at www.destinypharma.com and via RNS announcement.

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 (Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel, cost effective medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to
address the need for new drugs 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

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