Last checked at 15 Mar 2018 07:00
THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.
Destiny Pharma plc
("Destiny Pharma" or "the Company")
Destiny Pharma announces FDA Fast Track Designation for lead clinical candidate, exeporfinium chloride (XF-73)
Brighton, United Kingdom - 15 March 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 its lead clinical candidate exeporfinium chloride (XF-73) has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA). This follows the FDA's acceptance in February 2018 of an Investigational New Drug (IND) Application by the Company for the potentially ground-breaking drug.
Fast Track Designation is one of a package of measures and incentives available under the FDA's Qualifying Infectious Disease Product (QIDP) programme, set up to encourage development of novel ant-infective drugs. XF-73 was awarded QIDP status in October 2015. Fast Track designation is intended to expedite the potential availability of a drug to patients which, in the view of FDA, has promise in treating a serious or life-threatening condition and to fulfil an unmet medical need.
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
"We are pleased to have received Fast Track designation from the FDA for XF-73. This represents a further recognition of the potential for the drug and the need for an effective prevention for post-surgical staphylococcal infections, such as MRSA, that can result in significant complications for patients and significantly increased costs for hospitals. On our analysis of published data, there are approximately 40 million surgeries per annum, in the USA alone, where the patient is at risk of a post-surgical infection. We look forward to continuing our clinical development of XF-73 which remains on track and we expect Phase II data in 2019."
XF-73 has been developed from Destiny Pharma's novel, antimicrobial "XF" drug platform. Unlike traditional antibiotics, XF drugs have not been seen to generate bacterial resistance in industry-standard microbiology tests conducted 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.
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. XF-73 is targeted to address this important clinical need.
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 Broker)
Philip Davies / Will Goode, Corporate Finance
+44 (0)20 7894 7000
About XF-73
XF-73 is a synthetic, anti-microbial drug which has demonstrated potency against all Staphylococcus aureus strains, including drug resistant strains (MRSA), tested to date. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to bacterial death. XF-73 has already been through five successful Phase I/IIa 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