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Destiny Pharma plc announced on 22 July 2024 that new clinical data from its Phase 2b clinical trial on XF-73 Nasal gel in cardiac surgery patients has been accepted for presentation at the ID Week conference from 16-19 October 2024. The data shows that 46.5% (20 of 43) of patients in the XF-73 treatment arm received post-operative anti-staphylococcal antibiotics, compared to 70% (28 of 40) in the placebo group (p=0.045).
| Date | 22 Jul 2024 |
| Time | 07:00:10 |
| Category | Miscellaneous |
| ID | 1790X |
Destiny Pharma plc
("Destiny Pharma" or "the Company")
Cardiac surgery patients treated with XF-73 Nasal gel require significantly fewer post-surgical antibiotics
Further data from Phase 2b study to be presented at ID Week, a leading US infectious disease conference
Brighton, United Kingdom - 22 July 2024 - Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent and cure life threatening infections, today announced that new clinical data from its Phase 2b clinical trial on XF-73 in cardiac surgery patients has been accepted for presentation at the ID Week conference, the joint annual meeting of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America on the 16-19 October 2024 in Los Angeles, USA.
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
For further information, please contact:
Destiny Pharma plc
Chris Tovey, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440
[email protected]
FTI Consulting
Ben Atwell / Simon Conway
+44 (0) 203 727 1000
About Destiny Pharma
Destiny Pharma is an innovative, clinical-stage biotechnology company focused on the development and commercialisation of novel medicines that can prevent life-threatening infections. The Company's drug development pipeline includes two late-stage assets XF-73 Nasal gel, a proprietary drug targeting the prevention of post-surgical staphylococcal hospital infections including MRSA and NTCD-M3, a microbiome-based biotherapeutic for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US.
For further information on the company, please visit www.destinypharma.com.
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