DEST Destiny Pharma Plc

The title of the presentation is, 'Impact of Exeporfinium Chloride (XF-73) Nasal Gel on the Use of Post-Operative Anti-staphylococcal Antibiotics in Cardiovascular Surgery Patients: Results from a Randomised, Placebo-Controlled Phase 2 Study.'

Previously, the Company reported on achieving the primary endpoint for XF-73 Nasal gel, i.e. >99% reduction in nasal S. aureus compared to placebo one hour before open heart surgery, (p < 0.0001), Mangino et al. 2023¹.

Further planned data analysis of a secondary endpoint within the clinical trial investigated the use by physicians of post-surgical systemic antibiotics prescribed >48 hours after surgery. Significantly fewer patients in the XF-73 treatment arm received post-operative anti-staphylococcal antibiotics: 46.5% (20 of a total population of 43), compared to 70% (28 of a total population of 40) in the placebo group, p=0.045, which suggests that antibiotics may have been prescribed as an early intervention in more patients in the placebo arm.

The observed reduction of the use of post-operative antibiotics in the XF-73 arm is consistent with the principles of good antimicrobial stewardship which are crucial for managing and preventing infections more effectively and for maintaining the efficacy of antibiotics, reducing healthcare complications, and improving patient safety.

Additional advantages of the XF-73 Nasal gel include the short, 24 hour, pre-surgical dosing regimen, rapidity of S. aureus nasal decolonisation, remote likelihood of resistance emergence, and the duration of effect. These features provide a good fit with clinical practice, potentially enabling infection risk reduction peri-operatively, enhancing flexibility for scheduling surgeries, and augmenting antibiotic stewardship efforts. Phase 3 studies are being planned to evaluate and gain regulatory approval for XF-73.

XF-73 has also demonstrated efficacy against the hospital superbug methicillin-resistant Staphylococcus aureus (MRSA). In studies published last year XF-73 was potent against all 840 MRSA strains collected from infected patients from 33 countries worldwide (Rhys Williams et al. 2023)² and was shown to be up to 1000 times more efficacious than nasal mupirocin (the most commonly used nasal antibiotic) at treating MRSA in a skin infection model, (Zhang et al. 2023)³.

Dr Debra Barker, Interim Chief Medical Officer of Destiny Pharma, said: "The data to be presented at ID Week highlights the ability of XF-73 Nasal gel to significantly reduce the need for post-surgical antibiotic use. With antimicrobial resistance continuing to present an existential threat, these data highlight the value that XF-73 Nasal can provide in meeting this challenge while delivering favourable patient outcomes."

References:

1.    Mangino JE, Firstenberg MS, Milewski RKC, et al., 2023. 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. Infection Control & Hospital Epidemiology, 2023;44(7):1171-1173. doi:10.1017/ice.2023.17

2.    William Rhys-Williams, Helen Marie Galvin and William Guy Love, 2023. Screening of the novel antimicrobial drug, XF-73, against 2,527 Staphylococcus species clinical isolates. Frontiers in Cellular and Infection Microbiology, 2023; 13. doi.org/10.3389/fcimb.2023.1264456

3.    Zhang, C., Li, J., Lu, R., Wang, S., Fu, Z., & Yao, Z., 2023. Efficacy of a Novel Antibacterial Agent Exeporfinium Chloride, (XF-73), Against Antibiotic-Resistant Bacteria in Mouse Superficial Skin Infection Models. Infection and Drug Resistance, 16, 4867-4879. doi.org/10.2147/IDR.S417231