TIDMDEST
RNS Number : 6493K
Destiny Pharma PLC
12 April 2018
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 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
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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