Destiny Pharma opens IND ahead of XF-73 US trials

RNS Number : 8564F

Destiny Pharma PLC

26 February 2018

 

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Destiny Pharma plc

("Destiny Pharma" or the "Company")

Destiny Pharma opens IND for its novel anti-infective drug XF-73 ahead of commencing US clinical trials

Brighton, United Kingdom - 26 February 2018 - Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti-microbial drugs, which address the global problem of anti-microbial resistance (AMR), today announces that the US Food and Drug Administration (FDA) has accepted an Investigational New Drug application (IND) for the Company's lead clinical drug candidate, XF-73. This is being developed for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA).

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

"Destiny Pharma is one of only a small number of UK biotech companies which have antibacterial drugs at the clinical stage of development. We are pleased to open the IND and are looking forward to starting the clinical programme and reporting the Phase 2 data in 2019. The US is the largest potential market for this drug candidate and XF-73 could be the first drug approved for the US FDA's newly defined indication of "prevention of post-surgical staphylococcal infection". We look forward to continuing to advance XF-73 through clinical development."

XF-73 has been developed from Destiny Pharma's novel, antimicrobial "XF" drug platform. Unlike most antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests to date and therefore have significant potential to address the global threat of AMR. XF-73 has been shown to kill bacteria very rapidly and therefore may be an effective new treatment in the reduction of bacterial infections in hospital patients, including those caused by MRSA. XF-73 is administered topically as a nasal gel whereby it reduces the nasal carriage of the bacteria Staphylococcus aureus which is the source of many post-surgical bacterial infections.  Approximately a third of all patients across the world have this nasal carriage as they enter surgery and it is has the potential to be a very valuable market due to the millions of surgical procedures carried out each year.

As stated at the IPO in September 2017, under the new IND, Destiny Pharma will now complete certain standard Phase 1 studies in the US and will also be able to finalise the study design of the Phase 2 clinical trial. This Phase 2 study will evaluate the nasal anti-staphylococcal efficacy and clinical safety of XF-73 compared to placebo in pre-surgical patients at risk of infection. The study design will be closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

Following a review of clinical trial data, XF-73 was awarded Qualifying Infectious Disease Product (QIDP) status in October 2015 by the US FDA. Within the QIDP award, the US FDA also confirmed a new US disease indication for XF-73; namely the 'Prevention of post-surgical staphylococcal infections'. This represents a new US market for which no existing product is approved. QIDP status identifies XF-73 as a drug that is intended to treat serious or life-threatening infections, including those caused by antibiotic resistant pathogens. Destiny estimates the potential global market for XF-73 to be over one billion US dollars.

MRSA is one of the most prominent superbugs and a major cause of hospital associated infection and featured in the WHO's 'most dangerous' list of superbugs published in 2017. The WHO followed US and European guidelines in 2016 by recommending the screening and decolonisation of MRSA and all strains of Staphylococcus aureus in pre-surgical patients undergoing high risk surgeries in a step designed to help prevent such infections.

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Simon Sacerdoti, CFO

[e-mail]

[phone]

FTI Consulting

Simon Conway / Victoria Foster Mitchell

[e-mail]

[phone]

Cantor Fitzgerald Europe (Nominated Adviser and Broker)

Philip Davies / Will Goode, Corporate Finance

[phone]

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

 

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