MTFB Motif Bio PLC

Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announced today that four iclaprim abstracts have been accepted for presentation at the upcoming 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2019) to be held in Amsterdam, The Netherlands, April 13-16, 2019.

ECCMID brings together leading experts in the infectious diseases, infection control and clinical microbiology sector to present and discuss the latest results.

Details for each presentation and poster are noted below, including links to the related abstracts, which are available at https://www.eccmidlive.org. 

1. An efficacy analysis by lesion size of iclaprim versus vancomycin in patients with acute bacterial skin and skin structure infections: pooled phase III REVIVE trials (#O0303)Session type:  Mini oral e-poster session Session:  Clinical trials with recently approved or late-stage development antibioticsDate and Time:  April 13, 2019, 2:45-3:45 PMThe link to the abstract is available here.

2. Surveillance of iclaprim activity against Gram-positive cocci, including antibiotic-resistant strains, collected from patients with skin and skin structure infections during 2017 from European and American hospitals (#P1884)Session type:  Paper posterSession name:  In vitro activity of newer antibacterial agentsDate and time:  April 15, 2019, 1:30-2:30 PMThe link to the abstract is available here.

3. Iclaprim versus vancomycin for patients with acute bacterial skin and skin structure infection complicated by Staphylococcus aureus or streptococcal bacteraemia: a pooled analysis of the phase III REVIVE trials (#P2287)Session type:  Paper posterSession name:  Skin and soft tissue infectionsDate and time:  April 16, 2019, 12:30-1:30 PMThe link to the abstract is available here.

4. Pharmacokinetics of iclaprim by age, weight, race and renal/hepatic function in patients with acute bacterial skin and skin structure infections: phase III REVIVE trials (#O1162)Session type:  Oral session Session: PK/PD to guide dosing in special populationsDate and Time: April 16, 2019, 1:30 PM-3:30 PMThe link to the abstract is available here.

Additionally, an abstract on results from a study on the real-world incidence of vancomycin-associated nephrotoxicity in patients hospitalised with ABSSSI will be presented by Michael J. Rybak, PharmD, MPH, FCCP, BCPS, Associate Dean for Research, Professor of Pharmacy and Medicine Director, The Anti-Infective Research Laboratory, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University:

Real-world incidence of vancomycin-associated nephrotoxicity in hospitalised patients with acute bacterial skin and soft structure infections (#P2297)

Session type:  Paper posterSession:  Skin and soft tissue infectionsDate and Time: April 16, 2019, 12:30-1:30 PM

The link to the abstract is available here.

For further information please contact:

Motif Bio plc	ir@motifbio.com
Graham Lumsden (Chief Executive Officer)
Walbrook PR Ltd. (UK FINANCIAL PR & IR)	+44 (0)20 7933 8780
Paul McManus/Helen Cresswell/Lianne Cawthorne	motifbio@walbrookpr.com
MC Services AG (EUROPEAN IR)	+49 (0) 89 210 2280
Raimund Gabriel	raimund.gabriel@mc-services.eu
Russo Partners (U.S. PR)	+1 (858) 717-2310 or +1 (212) 845 4272
David Schull	david.schull@russopartnersllc.com

Note to Editors:

About Motif BioMotif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant Gram-positive bacteria, including MRSA. The Company’s lead product candidate is iclaprim. Motif Bio is seeking approval of iclaprim from the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). More than 3.6 million patients with ABSSSI are hospitalised annually in the U.S. It is estimated that up to 26% of hospitalized ABSSSI patients have renal impairment.

The Company also has plans to develop iclaprim for hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), as there is a high unmet need for new therapies in this indication.  A Phase 2 trial in patients with HABP has been successfully completed and a Phase 3 trial is being planned. Additionally, iclaprim has been granted orphan drug designation by the FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis and is in preclinical development for this indication.

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status for the ABSSSI indication. If approved for the ABSSSI indication as a New Chemical Entity, iclaprim will be eligible for 10 years of market exclusivity in the U.S. from the date of first approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe, 10 years of market exclusivity is anticipated.  Motif is also building a patent estate to provide additional protection for iclaprim and has two U.S. method of use patents issued that will expire in 2037.

Forward-Looking Statements

This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialise its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialisation, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates, (x) Motif Bio’s ability to raise additional capital to sustain its operations and pursue its strategy and (xi) the factors discussed in the section entitled “Risk Factors” in Motif Bio’s Annual Report on Form 20-F filed with the SEC on April 10, 2018, which is available on the SEC’s web site, www.sec.gov. Motif Bio undertakes no obligation to update or revise any forward-looking statements.