Second positive Phase 1 trial data from XF-73 skin irritation study
Primary objective achieved by both XF-73 concentrations
Next step is key Phase 2b trial for XF-73 in the prevention of post-surgical staphylococcal infections
Positive data also supports second clinical programme of XF-73 in dermal infection indications
Brighton, United Kingdom – 28 January 2019 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, which address the global problem of antimicrobial resistance (AMR), today announces positive data and the non-irritant classification for its XF-73 nasal gel from the second Phase 1 safety clinical study examining the drug’s potential to cause irritation when administered topically.
The study, required under the Investigational New Drug (IND) application opened in February 2018, achieved the primary objective of a low cumulative irritancy score for both concentrations (0.05% w/w and 0.2% w/w) with high statistical significance when compared to a placebo of distilled water.
Neil Clark, Chief Executive of Destiny Pharma, commented:
“We are very pleased with the positive outcome in this second Phase 1 study, which confirms the good safety profile of the XF-73 nasal gel formulation. We will now finalise plans for our key Phase 2b study testing XF-73 nasal gel as a novel therapy for the prevention of post-surgical staphylococcal infections, including MRSA. This is our lead indication targeting a billion-dollar US market and there is a clear medical need for a new drug that is safe, cost-effective and addresses the global medical concerns of anti-microbial resistance.
These positive results also support the advancement of XF-73 in Destiny Pharma’s Phase 1 dermal infection programme and reinforce the target product profile of XF-73 for both indications. XF-73 nasal gel is planned to move into Phase 2b clinical trials under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designation. This study will examine the nasal antibacterial activity and safety of the 0.2% w/w XF-73 nasal gel in over 150 patients at risk of post-surgical infections. The study design is under review at the FDA and it is planned to report data towards the end of 2019.”
Further information on the Phase 1 clinical study
The Phase 1 clinical study, conducted in the US, enrolled 35 volunteers who received two XF-73 nasal gel clinical formulations at anti-Staphylococcal concentrations (0.05% w/w and 0.2% w/w) daily for 21 consecutive days on intact and abraded skin. Both XF-73 concentrations yielded mean cumulative irritations scores which were significantly lower than the mean cumulative irritancy score of distilled water (p<0.0001).
The investigators did not report any XF-73 adverse events during the study and no XF-73 was detected in blood samples taken, confirming earlier dermal and nasal clinical trials which also demonstrated no XF-73 appeared in the bloodstream, and reinforcing its excellent safety profile. These are key advantages for XF-73 for nasal administration to eradicate bacteria Staphylococcus aureus, including Methicillin-resistant Staphylococcus aureus (MRSA), that are a common cause of potentially lethal post-surgical infections.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
+44 (0)1273 704 440