Amphion Innovations PLC FDA Results (2288K)
15 April 2015 - 4:02PM
UK Regulatory
TIDMAMP TIDMMTFB
RNS Number : 2288K
Amphion Innovations PLC
15 April 2015
Amphion Innovations plc
("Amphion", the "Company" or the "Group")
Amphion Partner Company, Motif Bio plc, Gains FDA Agreement to
Enter Phase 3 Clinical Development with Iclaprim
Iclaprim safety and efficacy to be studied by Motif in two
serious and life-threatening infections
London and New York, 15 April 2015 - Amphion Innovations (LSE:
AMP), a developer of medical, life science, and technology
businesses, is pleased to announce that the U.S. Food and Drug
Administration ("FDA") has agreed to the proposed Phase 3
development programme for Amphion's Partner Company Motif Bio plc's
("Motif") lead product candidate, iclaprim. The Phase 3 programme
is designed to obtain marketing approval for an intravenous
formulation of iclaprim in the treatment of acute bacterial skin
and skin structure infections ("ABSSSI") and hospital acquired
bacterial pneumonia ("HABP") caused by Gram positive pathogens,
including resistant strains of MRSA (methicillin-resistant
Staphylococcus aureus) and MDRSP (multi-drug resistant
Streptococcus pneumoniae). The FDA confirmed that two ABSSSI trials
or one ABSSSI trial plus one HAPB trial meeting their pre-specified
primary endpoints are required for approval of iclaprim. Motif is
working to determine the costs and timeline of these options. The
first Phase 3 trial for ABSSSI is expected to commence in the
second half of 2015.
Amphion owns 44.09% of Motif's issued equity in addition to a
convertible loan in the amount of $3.55 million.
Richard Morgan, CEO of Amphion, commented:
"We are delighted to share the positive results of yesterday's
meeting with the FDA. We welcome the support for studies that we
believe will prove iclaprim to be safe and effective in treating
serious and life-threatening infections including those caused by
multi-drug resistant bacteria."
Enquiries:
Amphion Innovations plc
Charlie Morgan +1 212 210
www.amphionplc.com 6224
Plumtree Capital (FINANCIAL
ADVISER)
Stephen Austin
Panmure Gordon Limited (Nomad +44 (0)207
and Broker) 183 5860
Freddy Crossley/ Duncan Monteith
(Corporate Finance)
Charlie Leigh-Pemberton (Corporate +44 (0)207
Broking) 886 2500
Yellow Jersey PR Limited (FINANCIAL
PR)
Dominic Barretto/Philip Ranger/Fiona +44 (0) 7768
Walker 537 739
About Amphion Innovations plc
Amphion Innovations is a developer of medical, life sciences and
technology businesses. We use our extensive experience in company
building to invest and build shareholder value in high growth
companies in the US and UK. Amphion has significant shareholding in
7 Partner Companies developing proven technologies targeting
substantial commercial marketplaces. The Amphion model has been
refined to optimize the commercialisation of patents and other
intellectual property within the Partner Companies. The Partner
Companies collectively own or control over 200 separately
identified pieces of intellectual property, a number which grows
rapidly each year.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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