Destiny Pharma plc
(“Destiny Pharma” or “the Company”)
Destiny Pharma announces positive data from XF-73 Phase 1 skin irritation study
Positive data supports product opportunities for XF-73 in dermal infection indications
Data also supports planned Phase 2 clinical trial of XF-73 nasal gel for the prevention of post-surgical infection
Brighton, United Kingdom – 26 July 2018 – 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 from the first of two Phase 1 safety clinical studies of XF-73, examining the drug’s potential to cause dermal irritation. XF-73 is the Company’s lead candidate for the prevention of post-surgical staphylococcal infections.
The positive results support the potential of XF compounds in dermal infection indications and also reinforce the target product profile of XF-73 in advance of it entering a Phase 2 clinical trial under the US Food and Drug Administration (FDA) Qualified Infectious Disease Product (QIDP) and Fast Track designations. The Phase 2 study will examine a nasal gel formulation of the drug for the prevention of post-surgical infections, which is on plan to report data in H2 2019.
The Phase 1 clinical study, completed in the US under an Investigational New Drug (IND) from the FDA, demonstrated that XF-73 in aqueous solution, at high concentrations, when applied daily for five days to intact and abraded skin (by tape stripping) has a similar irritancy potential to water under occluded (covered) conditions in a shorter version of an industry standard cumulative irritancy dermal safety study. The volunteer clinical trial was blinded and placebo controlled with pharmacokinetic sampling.
This finding on abraded skin, combined with the lack of systemic absorption, (i.e. no XF-73 was seen in blood samples taken throughout the study), also supports the profile of XF-73 (and potentially other XF drugs) as new treatment options for dermal infections.
Neil Clark, Chief Executive of Destiny Pharma, commented:
“We are pleased to successfully complete this Phase 1 study, confirming the safe profile demonstrated to date in all other XF-73 clinical studies. We are also excited that the abraded skin data supports the potential for the XF platform in treating difficult skin infections and we will now assess our drug development options in that therapeutic area.”
These study results add to the existing strong safety and efficacy dataset already established by Destiny Pharma in preparation for the Phase 2 planned to report data in H2 2019 to assess the effectiveness of XF-73 nasal gel in significantly reducing nasal Staphylococcus aureus prior to surgery compared to placebo. A second Phase 1 study with the XF-73 nasal gel formulation will be completed later in 2018 in a similar skin irritation potential safety volunteer trial. On completion of this study, XF-73 nasal gel will be ready to commence the Phase 2 trial.
Destiny Pharma will now finalise a programme to develop an XF drug targeting the prevention and/or treatment of specific dermal infections. As with all XF drugs, the potential target product profile will include a safe, rapid kill of relevant bacteria whilst generating low or no AMR due to the unique mechanism and the rapidity of the XF mode of action.
For further information, please contact:
Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, CFO
+44 (0)1273 704 440
Simon Conway / Victoria Foster Mitchell
+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
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.
XF-73 is indicated 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
Forward looking statements
Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the company believe that the expectations reflected in these statements are reasonable, but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.