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FDA Meeting Minutes Confirming Iclaprim Phase III

28th May 2015 07:00

RNS Number : 4282O
Motif Bio PLC
28 May 2015
 

28 May 2015

Motif Bio plc.

("Motif" or the "Company")

Motif Receives FDA Meeting Minutes Confirming Iclaprim Phase III Clinical Development Programme

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received the official meeting minutes from the U.S. Food and Drug Administration (FDA) guidance meeting which was held on 14 April 2015. The minutes confirm the FDA's agreement with Motif's Phase III clinical development programme for iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria.

Iclaprim, a novel selective inhibitor of microbial dihydrofolate reductase (DHFR), is being developed as an intravenous (IV) formulation to treat acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP). The FDA has confirmed that two successful Phase III trials are required for the approval of iclaprim.

Graham Lumsden, CEO of Motif Bio plc, commented:

"This FDA confirmation supports Motif moving forward to begin the iclaprim Phase III clinical programme. The trials will investigate the safety and efficacy of iclaprim in patients with ABSSSI and HABP, two serious and life threatening infections caused by multi‐drug resistant bacteria. We believe that iclaprim may be an important addition in the fight against life threatening infections, a battle that is currently being lost to increasing antimicrobial resistance."

 

Enquiries

 

Motif Bio plc.

Graham Lumsden (Chief Executive Officer)

Robert Bertoldi (Chief Financial Officer)

www.motifbio.com

[email protected]

 

MC Services AG (TRADE PR)

Raimund Gabriel

Shaun Brown

 

 

 

+49 (0) 89 210 2280

+44 (0) 207 148 5998

 

Cairn Financial Advisers LLP (NOMAD)

 

+44 (0) 20 7148 7900

Tony Rawlinson

Carolyn Sansom

 

Northland Capital Partners Limited (BROKER)

+44 (0) 20 7382 1100

Gerry Beaney/David Hignell

John Howes/Mark Treharne (Broking)

 

Plumtree Capital Limited (FINANCIAL ADVISOR)

+44 (0) 207 183 2493

Stephen Austin

 

Yellow Jersey PR Limited (FINANCIAL PR)

Dominic Barretto

Fiona Walker

 

+44 (0) 7768 537 739

Notes to Editors:

Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi).

Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings.

This information is provided by RNS
The company news service from the London Stock Exchange
 
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