31 Oct 2016 07:00
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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.