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FDA Results

15th Apr 2015 07:01

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

www.amphionplc.com

 

+1 212 210 6224

 

Plumtree Capital (FINANCIAL ADVISER)

Stephen Austin

 

Panmure Gordon Limited (Nomad and Broker)

Freddy Crossley/ Duncan Monteith (Corporate Finance)

Charlie Leigh-Pemberton (Corporate Broking)

+44 (0)207 183 5860

 

+44 (0)207 886 2500

 

 

 

Yellow Jersey PR Limited (FINANCIAL PR)

Dominic Barretto/Philip Ranger/Fiona Walker

 

+44 (0) 7768 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
 
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