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Data Confirming Standard Clinical Trial Dosage

31 Oct 2016 07:00

RNS Number : 8019N
Motif Bio PLC
31 October 2016
 

 

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION

 

This announcement contains inside information.

 

Motif Bio plc

("Motif Bio" or the "Company")

 

Data supporting optimized Iclaprim dosing in REVIVE trial presented at IDWeek 2016

 

Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that data were presented at IDWeek 2016 in New Orleans supporting the fixed dose of iclaprim designed to optimize efficacy and safety outcomes in the Company's ongoing Phase 3 REVIVE clinical trials.

 

Using the pharmacokinetic/pharmacodynamics (PK/PD) data collected from 470 patients enrolled in the previously conducted Phase 3 cSSSIs trials (ASSIST-1 and -2), population PK modeling was used to identify an optimal fixed dose regimen.

 

Iclaprim administered as an 80 mg infusion over two hours provided a 28% increase in AUC/MIC and a 32% increase in the T > MIC compared to the dosing regimen used in the ASSIST trials. This dosing regimen maintains the effective level of iclaprim for longer, while reducing the peak concentration, a property that has been associated with adverse effects. The iclaprim fixed dose may help reduce the resources required in hospitals since dosage adjustment by health care professionals is avoided, and overall hospital treatment costs may be lower, especially in renally impaired patients.

 

The full poster can be downloaded at:

https://idsa.confex.com/idsa/2016/webprogram/Paper56639.html

 

 

A registration statement relating to the Company's securities has been filed with the SEC, but has not yet become effective. Such securities may not be sold, nor may offers to buy the securities be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

Forward-looking statements

This news release contains forward-looking statements that reflect Motif Bio's current expectations regarding future events, including statements regarding the potential clinical benefits and commercial potential of iclaprim. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of Motif Bio's clinical development strategies, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of iclaprim and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in Motif Bio can be found in Motif Bio's filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Motif Bio undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

For further information please contact:

 

Motif Bio plc

Richard Morgan (Chairman)

Graham Lumsden (Chief Executive Officer)

 

info@motifbio.com

 

Zeus Capital Limited (NOMAD & BROKER)

Phil Walker/Giles Balleny

Dominic Wilson

 

+44 (0)20 3829 5000

Northland Capital Partners Limited (BROKER)

Patrick Claridge/ David Hignell

John Howes/ Rob Rees (Broking)

 

+44 (0)20 3861 6625

Walbrook PR Ltd. (FINANCIAL PR & IR)

Paul McManus

Mike Wort

+44 (0)20 7933 8780 or motifbio@walbrookpr.com

Mob: +44 (0)7980 541 893

Mob: +44 (0)7900 608 002

MC Services AG (EUROPEAN IR)

Raimund Gabriel

+49 (0)89 210 2280

 

 

About Motif Bio

Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), which is often caused by MRSA (methicillin resistant Staphylococcus aureus). We are currently enrolling and dosing patients in two global Phase 3 clinical trials (Revive 1 and Revive 2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-1 is expected in the second quarter of 2017 and REVIVE-2 is on track for data readout in the second half of 2017.

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
RESEAPEPAFFKFFF
Date   Source Headline
14th Sep 201611:15 amRNSIssue of Equity
8th Sep 20167:00 amRNSRe-negotiation of the terms of the CPNs
8th Sep 20167:00 amRNSUPDATE ON REVIVE-1 PHASE 3 CLINICAL TRIAL
26th Aug 20167:00 amRNSChief Medical Officer presents at congress in USA
22nd Aug 20164:31 pmRNSDirector/PDMR Shareholding
16th Aug 20167:00 amRNSHalf-year Report
9th Aug 20165:24 pmRNSHolding(s) in Company
9th Aug 20167:00 amRNSUpdate on timing of proposed US Public Offering
5th Aug 20167:00 amRNSHolding(s) in Company
1st Aug 20162:15 pmRNSResult of General Meeting
28th Jul 20164:22 pmRNSPreliminary prospectus filed
18th Jul 20164:38 pmRNSDirector/PDMR Shareholding
13th Jul 20167:01 amRNSCircular to allot shares for proposed US Offering
13th Jul 20167:01 amRNSNotice of Intention to List on NASDAQ by Motif Bio
13th Jul 20167:00 amRNSFiles For Proposed U.S. Public Offering
1st Jul 20167:00 amRNSDirectorate Change
2nd Jun 20163:37 pmRNSResult of AGM
1st Jun 20167:00 amRNSCEO to Present at BIO 2016
24th May 20167:00 amRNSInvestor presentation
28th Apr 20167:03 amRNSRe. Amphion Innovations plc
25th Apr 20167:00 amRNSReplay for Analyst & Investor Conference Call
22nd Apr 20167:00 amRNSGrant of Options
21st Apr 20167:00 amRNSAnnual Report and Accounts 2015
20th Apr 20167:00 amRNSFinal Results
18th Apr 20167:00 amRNSResults Conference Call Details
14th Apr 20167:00 amRNSSenior Appointments
23rd Mar 20167:00 amRNSMotif Bio to present at BIO-Europe Spring
14th Mar 20167:00 amRNSAppointment of strategic adviser
2nd Mar 20167:00 amRNSFirst patient dosed in iclaprim Phase 3 trials
23rd Feb 20165:39 pmRNSHolding(s) in Company
22nd Feb 20167:00 amRNSWebcast on Combating antibiotic resistance
25th Jan 20167:00 amRNSAppointments of U.S. finance adviser and auditor
22nd Dec 20157:00 amRNSExercise of Warrants
15th Dec 20157:00 amRNSIclaprim Clinical Trial Supplies Manufactured
7th Dec 20157:00 amRNSMotif selected to present at Biotech Showcase
24th Nov 20157:00 amRNSReceipt of FDA Concurrence
11th Nov 20157:00 amRNSEuropean Agreement for Iclaprim Development
27th Oct 20157:00 amRNSSelected to Present at BIO-Europe 2015
21st Oct 20157:00 amRNSExercise of Options
16th Oct 20157:00 amRNSLeading CRO to Conduct Iclaprim Phase III Trials
13th Oct 20157:00 amRNSResults of Two Posters on Iclaprim at ID Week 2015
12th Oct 20153:59 pmRNSExercise of Options
5th Oct 20154:41 pmRNSDirectors Dealings
29th Sep 20157:01 amRNSPresentation of Two Posters on Iclaprim
23rd Sep 20153:04 pmRNSIssue of Shares for Exercised Warrants
3rd Sep 20157:00 amRNSFDA Grants Fast Track Designation for Iclaprim
2nd Sep 20157:00 amRNSAppointment of IR Adviser
2nd Sep 20157:00 amRNSParticipation at Upcoming Investor Events
27th Aug 20157:01 amRNSInterims Results for the 6 months to 30 June 2015
24th Aug 20157:00 amRNSPotent Efficacy of Iclaprim Confirmed

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