Last checked at 28 Jan 2019 07:00
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Destiny Pharma plc
("Destiny Pharma" or "the Company")
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
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
pressoffice@destinypharma.com
+44 (0)1273 704 440
FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000
Cantor Fitzgerald Europe (Nominated Adviser and Joint Broker)
Philip Davies / Will Goode, Corporate Finance
Andrew Keith, Healthcare Equity Sales
+44 (0)20 7894 7000
finnCap Ltd (Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500
About XF-73
XF-73 is a synthetic anti-microbial active against all tested Staphylococcus aureus strains, including drug resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through five successful Phase I/IIb clinical trials showing rapid antibacterial action. In standard microbiology studies XF drugs have demonstrated a unique no/low resistance profile that means that XF compounds have the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility.
XF-73 is being studies for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are particular groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines that represent a new approach to the treatment of infectious disease. These potential new medicines are being developed to address the need for new drugs for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as "superbugs". Tackling anti-microbial resistance has become a global imperative recognised by the WHO and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com
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