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REG - Destiny Pharma PLC - Landmark XF-73 Phase 2 data published in journal

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RNS Number : 0651U  Destiny Pharma PLC  24 March 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 (https://doi.org/10.1017/ice.2023.17)

 

It highlights the following key results:

 

ü 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)

ü 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

ü These positive results were achieved with just 3 doses of XF-73 nasal gel
in the 24 hours before the surgical incision

ü 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
(https://www.destinypharma.com/2022/12/07/7-december-2022-xf-73-nasal-phase-3-development-plans-finalised/)
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 (mailto:pressoffice@destinypharma.com)

 

Optimum Strategic Communications
Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper

+44 (0) 7931 5000 66
DestinyPharma@optimumcomms.com (mailto: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-COV(TM), 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
(http://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
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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,
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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
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the Group's actual results of operations, financial condition and the
development of the industries in which the Group operates are consistent with
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developments may not be indicative of results or developments in subsequent
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