Destiny Pharma announces positive data from XF-73 Phase 1 skin irritation study

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
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.

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.

Research collaboration with Aston University to investigate new XF-platform drug candidates

 Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Destiny Pharma announces research collaboration with Aston University to investigate new XF-platform drug candidates

Research to investigate potential antimicrobial candidates against biofilms

Brighton, United Kingdom – 17 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 it has signed a three-year research collaboration agreement with Aston University. The research is intended to examine novel compounds from the Company’s XF-platform and assess their potential to prevent, control and eradicate dangerous bacteria and biofilms.

Serious infections are sometimes caused and exacerbated by biofilms where bacteria can hide and be protected from traditional anti-infective agents. XF compounds have already shown efficacy in biofilm models and this research project will explore that further and look at the mechanisms of action. The collaboration with Aston University will also look at other potential uses of the XF platform in the prevention and treatment of serious, drug resistant infections. Aston University’s Department of Life and Health Sciences has established expertise in in vitro bacterial biofilm models that will be utilised in the collaboration. Financial terms of the collaboration have not been disclosed.

Tony Worthington, Reader in Clinical Microbiology at Aston University, commented:

“The XF series of compounds have distinctive properties that could provide important advances in the treatment of biofilm-related infections. We are delighted to work with Destiny Pharma on the evaluation of these compounds.”

Neil Clark, Chief Executive Officer of Destiny Pharma, added:

“We are excited to collaborate with the expert team at Aston University and look forward to exploring the further potential of our XF-platform, especially in the treatment of infections involving biofilms. Biofilms represent a significant barrier to antimicrobial treatment and this collaboration, which is in line with our stated strategy, may identify additional clinical candidates that are safe, effective and with a significantly reduced level of antimicrobial resistance.”

Biofilms are an increasing problem that are poorly treated by current drugs as they act as a protective barrier for bacteria and have been traditionally associated with indwelling medical devices (for example, heart valves and joint replacements) and invasive medical devices (for example, catheters and endoscopes). It is now acknowledged that biofilms have a major involvement in bacterial vaginosis, urinary tract infections, middle-ear infections, gingivitis, corneal infections and more lethal diseases such as endocarditis and cystic fibrosis. More recently it has been noted that bacterial biofilms may impair cutaneous wound healing and reduce topical antibacterial efficiency in healing or treating infected skin wounds, including burns and leg ulcers.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Simon Sacerdoti, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

Aston University
Press and Public Relations
pr@aston.ac.uk
+44 (0)121 204 4592

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.

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

About Aston University

Aston University campus pictures

Founded in 1895 and a University since 1966, Aston is a long established university led by its three main beneficiaries – students, business and the professions, and our region and society. Aston University is located in Birmingham and at the heart of a vibrant city and the campus houses all the university’s academic, social and accommodation facilities for our students.  Professor Alec Cameron is the Vice Chancellor & Chief Executive.

Aston has been a leading university for graduate employment success for over 25 years and our students do extremely well in securing top jobs and careers.  Our strong relationships with industry partners mean we understand the needs of employers, which is why we are also ranked in the top 20 for graduate employability.

The School of Life & Health Sciences at Aston University pursues interdisciplinary research at the interface between laboratory and clinic. The Microbiology Research Group is part of a team of 20 principal investigators focused on a range of processes that are fundamental to health and disease: infection, inflammation, fibrosis, metabolism, tissue modeling and regeneration. The overarching aim of this group is to promote health through specific understanding of and intervention in these processes. For further information, please visit http://www.aston.ac.uk/lhs/research/centres-facilities/cell-tissue-biomedical-research/.

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.