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

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.”

[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).