XF-73 Nasal final Phase 3 development plans

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

US FDA/CDC workshop highlights the need for new approaches
for the prevention of hospital-acquired infections

 ·    Particular support for decolonisation of pathogens which is the approach taken by its XF-73 Nasal programme

Brighton, United Kingdom, 07 December 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today reports on the publication of findings from the US Food and Drug Administration (FDA) and US Centers for Disease Control (CDC) public workshop on considerations for the prevention of hospital-acquired infection, which can be found here: https://info.rescueagency.com/en-us/drug-development-consideration-virtual-public-workshop-cdc-fda

This workshop brought together representatives from key US government regulators as well as pharmaceutical companies, infection control physicians and patient advocates to discuss the growing issue of hospital-acquired infections in the US and the clear need for new interventions that could address this issue.

Destiny Pharma attended the discussion and was very pleased that the meeting reinforced the Company’s conviction in infection prevention as a key component in the management of serious hospital-acquired infections. The text below is extracted from the published notes of the meeting and provides clear support for the Company’s approach with XF-73 Nasal and NTCD-M3.

Dr Michael Craig, (Director of Antimicrobial Resistance) at the US CDC stated:

·    “Decolonization is something that is very important to us at CDC and something that we think really holds a lot of potential in terms of saving lives and importantly addressing the challenges of antimicrobial resistance that we face, not only in the United States but around the world, and so from our perspective, and I think the bottom line for us, is focusing on drugs that could potentially prevent transmission of deadly pathogens, especially those that are antimicrobial resistant.”

·    “We need to have prevention modalities that can really stop the spread of infectious diseases and deadly pathogens and so what we would like is additional potential drugs that could be brought to bear so that we could further reduce and maybe even eliminate the risk of that colonization becoming an infection in an individual or that colonization spreading to others and being transmitted in sites like nursing homes or ICUs.”

Dr John Jernigan, (Director of HAI Prevention Research and Evaluation, CDC) stated:

·    “Decolonization, by its strict definition, refers to complete elimination of the colonizing microorganism, but for the purpose of our conversations today, I invite you to think about decolonization in a slightly broader context to include pathogen burden reduction or reduction in microbial load of the colonizing pathogen.”

·    “Reducing colonization may be a potent antibiotic resistance prevention strategy. Furthermore, because of their potential for indirect benefit, efforts to produce and improve and approve novel safe and effective decolonizing agents are likely to prevent substantially more harm from antibiotic resistance than can be prevented if we focus drug development solely on drugs that treat infections.”

Destiny Pharma’s infection prevention programmes

Destiny Pharma has two infection prevention clinical programmes that have delivered excellent Phase 2 data and are now heading towards their final Phase 3 clinical studies.

XF-73

XF-73 Nasal is a novel drug being developed by Destiny Pharma to eradicate S. aureus (SA), including MRSA from the nose before surgery to prevent post-surgical infection.  The use of this simple nasal gel before surgery will reduce the need for antibiotic decolonization and by reducing post-surgical infection it will also decrease the use of post-surgical antibiotics to treat infection. There are some 20 million high-risk surgeries and five million intensive care unit (ICU) patient admissions per year in the US alone, a third of whom carry SA in the nose, who could benefit.

NTCD-M3

NTCD-M3 is a single strain biotherapeutic being developed by Destiny Pharma for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria Clostridioides difficile (C. diff). These infections can cause significant inflammation and damage to the gut leading to an estimated 29,000 deaths annually in the US alone (a number comparable to the yearly deaths caused by prostate cancer).

Dr. Yuri Martina, CMO of Destiny Pharma, responded to the findings: “This workshop marks an important starting point for the FDA, CDC and the pharmaceutical industry to exchange ideas and thoughts which look at substantially increasing the development of new drugs addressing infection prevention. A shift in thinking is evident and it has been expressed by many of the speakers during the workshop. This encouragement from the FDA and CDC for new infection prevention products for the US market provides a supportive backdrop for Destiny Pharma’s approach, with its two late clinical stage products targeting infection prevention (XF-73 and NTCD-M3) whilst addressing the threat of antimicrobial resistance (AMR). Using the words of Dr. Craig – ‘Prevention ultimately saves lives’.”

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, Nick Bastin, Manel Mateus, Eleanor Cooper
DestinyPharma@optimumcomms.com
+44 20 3922 0891

finnCap Ltd (Nominated Advisor and Joint Broker)
Geoff Nash / George Dollemore, Corporate Finance
Alice Lane / Nigel Birks / Harriet Ward, Corporate Broking
+44 (0) 207 220 0500

Shore Capital (Joint Broker)
Daniel Bush / James Thomas / Lucy Bowden
+44 (0) 207 408 4090

MC Associates AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-0

Stern IR – US
Janhavi Mohite
+1-212-362-1200
Janhavi.Mohite@sternir.com

About Destiny Pharma

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 has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COVTM, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF drug research projects.

For further information, please visit  www.destinypharma.com  

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