15 Apr 2015 07:01
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 www.amphionplc.com
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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.