Company Announcements

Study gives strong support for potential of XF-73

Source: RNS
RNS Number : 2919P
Destiny Pharma PLC
18 October 2021
 

Destiny Pharma plc

("Destiny Pharma" or "the Company")

 

Major US hospital-based clinical trial highlights benefit of nasal decolonization to reduce ICU infections caused by Staphylococcus aureus

 

Strong support for potential of XF-73 nasal product

as alternative to mupirocin

 

 

Brighton, United Kingdom - 18 October 2021 - Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel medicines to prevent life threatening infections, notes the important study report presented at the leading international conference, IDWeek virtual meeting which took place on 30 September - 3 October 2021.

 

The Phase 4 study[1] was the largest ever of this type, with over 300,000 patients which explored the link between Staphylococcus aureus decolonisation and Intensive Care Units (ICU) infection rates. S.aureus remains a formidable infection-causing pathogen in the ICU and is the primary bacterial pathogen causing ICU infections in the USA, responsible for 23% of all infections and nearly half (44%) of which are caused by the multi-antibiotic resistant strain, MRSA.

 

The study, Swap Out Trial, was a 4-year project led by the renowned hospital infection expert, Professor Susan Huang (Professor of Infectious Diseases at the University of California Irvine School of Medicine) in coordination with Healthcare Corporation America and support from the US Government's Centers for Disease Control and Prevention (CDC). The study evaluated over 300,000 patients in 233 US ICU and compared levels of infection after the use of the current leading treatment, a nasal decolonisation antibiotic ointment - mupirocin - against a nasal antiseptic, iodophor.  The main conclusion was that overall the nasal antibiotic mupirocin was shown to be superior for the reduction of S.aureus clinical cultures compared to the nasal antiseptic iodophor (p< 0.001).

 

The study has positive implications for Destiny Pharma's novel XF-73 nasal gel which is being developed as a nasal S. aureus decolonisation medicine:

 

·       The issue of mupirocin resistance remains a global concern and products which are as effective but do not cause Antimicrobial Resistance (AMR) are urgently needed

 

·       The study indicates that the nasal antiseptic iodophor is not as effective as mupirocin and underlines the significant market opportunity for XF-73 as a much-needed new medicine for hospitals to help prevent infections in the ICU and the post-surgical setting

 

·       XF-73 nasal gel has the potential to deliver a Target Product Profile (TPP) with significant advantages over mupirocin including;

 

·       Effective nasal S. aureus decolonisation in 24 hours compared to 5 days for mupirocin (March 2021 Phase 2 data success)

·       Significantly quicker decolonisation and thus more cost-effective

·       Ultra-rapid bactericidal drug, novel mechanism of action and no propensity for resistance seen to its potent activity against MRSAs

·       Easy to use, patient compliance, non-irritant nasal gel formulation

·       Low cost of goods enabling pragmatic pricing/easier reimbursement

 

Destiny Pharma is currently in regulatory discussions concerning the appropriate Phase 3 clinical study design to enable marketing approval for XF-73 nasal gel in Europe and the USA.

 

Neil Clark, Chief Executive Officer of Destiny Pharma, said: "This large, multi-year study clearly supports the value of nasal treatment to remove S. aureus and shows yet again the significant interest in improving the efficacy of nasal decolonisation because it is a major contributor to delivering a reduction in post-surgical S. aureus infections.

 

"Destiny Pharma's XF-73 nasal gel is focused on delivering a novel decolonisation treatment and following the excellent Phase 2 clinical data, reported earlier in 2021, we remain committed to finalising our Phase 3 plans and bringing XF-73 to the hospital market to meet this clear and substantial clinical need. The Company believes strongly that XF-73 has the potential to provide a major step change and improvement in S. aureus decolonisation compared to mupirocin; XF-73 is faster acting with a broader antimicrobial action. Furthermore, XF-73 does not generate resistance (AMR), which remains a major concern with the continuing use of mupirocin."

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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 / Hollie Vile / Manel Mateus

 destinypharma@optimumcomms.com

+44 (0) 208 078 4357

 

finnCap Ltd (Nominated Adviser and 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)20 3705 9321

 

MC Associates AG

Anne Hennecke / Andreas Burckhardt

+49-211-529252-0

 

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-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects. 

 

For further information, please visit  https://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.

 

 

 

[1] Presentation 4 - 137: Hospital Cluster-Randomized Trial of Mupirocin-Chlorhexidine vs Iodophor-Chlorhexidine for Universal Decolonization in Intensive Care Units (ICUs) (Mupirocin Iodophor Swap Out Trial).

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