Landmark XF-73 Phase 2 data published in US journal

Friday March 24, 2023

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

Announces publication of XF-73 nasal gel Phase 2 data in leading US journal Infection Control & Hospital Epidemiology

Demonstrates significant reduction of nasal S. aureus in preoperative cardiac surgery patients

Brighton, United Kingdom – 24 March 2023 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, is pleased to announce the publication of landmark XF-73 clinical data in the leading US peer reviewed journal “Infection Control & Hospital Epidemiology”.  

The paper was published by Dr. Julie Mangino (Professor Emeritus, Division of Infectious Diseases, at The Ohio State University, US) who is the lead author and a member of the Data Safety Monitoring Committee for the clinical trial.

The paper is entitled, Exeporfinium Chloride (XF-73) Nasal Gel Dosed over 24 Hours Prior to Surgery Significantly Reduced Staphylococcus aureus Nasal Carriage in Cardiac Surgery Patients: Safety and Efficacy Results from a Randomized Placebo-Controlled Phase 2 Study’. https://doi.org/10.1017/ice.2023.17

It highlights the following key results:

  • Achieved the study primary endpoint: XF-73 showed a 99.5% reduction in S. aureus bacterial nasal carriage, which is a clinically relevant reduction in nasal carriage. This equates to a reduced nasal burden of S. aureus in patients undergoing open heart surgery by 2.5 log (CFU/ml) in the 24 hours immediately before surgery, a highly statistically significant result, (p<0.0001)
  • 83.7% of XF-73 nasal gel treated patients were completely decolonised of nasal S. aureus or exhibited a ≥99% reduction one hour ahead of surgery compared to just 25% in the placebo group
  • These positive results were achieved with just 3 doses of XF-73 nasal gel in the 24 hours before the surgical incision
  • XF-73 decolonisation of S. aureus was maintained throughout the perioperative period, which is considered to be when the risk of infection is highest

Dr. Julie Mangino, Professor of Infectious Disease at The Ohio State University, said: “XF-73 provides a rapidly effective and safe new agent to complement the armamentarium of skin/whole body decolonisation to prevent Staphylococcus aureus surgical site infections (SSI). Prevention is primary to avoid the morbidity and mortality of SSIs.”

Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “This is certainly the most important paper that we have published on XF-73 nasal gel. Peer-reviewed and published in a leading US infection control journal, will mean that the exceptional ability of our product to decolonise patients rapidly and effectively before surgery, will be shared and available to those in the field of hospital infection control. XF-73 nasal gel is a potential game changer in the fight to reduce the risk of post-surgical infections from hospital superbugs.”

Destiny Pharma plc has recently completed detailed interactions with the regulators and identified options for the final Phase 3 clinical development stage to obtain approval for the XF-73 nasal gel product in the US and Europe. The Company is actively seeking partners for the XF-73 nasal programme.

– END –

For further information, please contact:

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

Optimum Strategic Communications
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper
+44 (0) 7931 5000 66
DestinyPharma@optimumcomms.com

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

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

MC Services AG
Anne Hennecke / Andreas Burckhardt
+49-211-529252-12

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 2 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 on the company, please visit www.destinypharma.com

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.