Last checked at 12 Apr 2018 07:00
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Destiny Pharma plc
("Destiny Pharma" or "the company")
Destiny Pharma announces update on clinical programme for lead drug candidate XF-73
Started recruiting subjects in latest Phase 1 dermal study under US IND
FDA discussions have clarified overall clinical trial plans for XF-73
Phase 2b study on track to announce results in H2 2019
Brighton, United Kingdom - 12 April 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 an update on the scope and timing of the XF-73 (exeporfinium chloride) Phase 1 and Phase 2b clinical trial programmes following discussions with the US Food and Drug Administration (FDA). This process is in line with the Company's strategy set out at the time of the placing and admission to AIM and the current status is summarised below:
· As previously announced, in February 2018, Destiny Pharma opened an Investigational New Drug (IND) application and, in March 2018, was awarded Fast Track designation for the XF-73
· Destiny Pharma announces today that a Phase 1 dermal safety study, looking at potential skin irritation of XF-73 solution in up to 30 subjects, has started in a specialist US based unit
· The FDA has clarified that only one additional Phase 1 dermal safety study, looking at skin irritation of XF-73 nasal gel in up to 30 subjects, has to be completed before the planned Phase 2b trial can start
· Destiny Pharma is pleased to note that the FDA confirmed that the additional, larger, Phase 1 dermal safety study, looking at the potential for skin sensitisation of XF-73 nasal gel in 200 subjects, does not need to be completed before the Phase 2b study and is only required in advance of the start of Phase 3 trials. Destiny Pharma plans to complete this larger skin sensitisation study in parallel with the Phase 2b in 2019
· With these clarifications, Destiny Pharma is now finalising plans to start the Phase 2b trial. This trial will assess the efficacy of XF-73 against placebo in the nasal decolonisation of Staphylococcus aureus in approximately 150 patients prior to their undergoing hospital surgical procedures. The Company is on track to announce Phase 2b results in the second half of 2019, with the aim of delivering a Phase 3 ready package by the end of 2019
Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
"We are very pleased to get this confirmation from the FDA on the clinical pathway for our lead asset, XF-73. As we set out at the time of our admission to AIM, once the IND and Fast Track designation were confirmed we were expecting to be able to parallel track some of the standard Phase 1 studies and our Phase 2b study based on the existing safety profile of XF-73, and the FDA has now confirmed that this approach is appropriate. Over 160 subjects to date have been dosed with this potentially breakthrough antibacterial drug as a nasal formulation with no significant issues. The Company is well funded and the team at Destiny Pharma remains fully focused on delivering the agreed clinical plan."
XF-73, Destiny Pharma's lead asset, is a first-in-class drug candidate, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare burden in the hospital setting.
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 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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