UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934
For the Month of: February 2018
Commission File Number: 001-37847
MOTIF BIO PLC
(Exact name of registrant as specified in its charter)
125 Park Avenue
25th Floor
New York, New York 10011
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):o
MOTIF BIO PLC
FORM 6-K
MOTIF BIO TO PRESENT ICLAPRIM DATA AT ECCMID 2018
On February 21, 2018, Motif Bio plc (the Company) issued a regulatory news service announcement, a copy of which is attached as Exhibit 99.1 to this report on Form 6-K, announcing that three iclaprim abstracts have been accepted for presentation at the upcoming 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018), to be held in Madrid, Spain, April 21-24, 2018.
This report on Form 6-K (including the exhibits hereto) shall not be deemed to be filed for purposes of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Exhibits
Exhibit 99.1 |
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Regulatory news service announcement issued by Motif Bio plc, dated February 21, 2018, entitled Motif Bio to Present Iclaprim Data at ECCMID 2018. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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MOTIF BIO PLC | |
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By: |
/s/ Graham Lumsden |
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Name: |
Graham Lumsden |
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Title: |
Chief Executive Officer |
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Date: February 21, 2018
Exhibit 99.1
21 February 2018
Motif Bio plc
(Motif Bio or the Company)
Motif Bio to Present Iclaprim Data at ECCMID 2018
· Phase 3 trial results for REVIVE-2 in patients with ABSSSI
· Potential cost savings opportunities with iclaprim versus vancomycin
· Iclaprim in vitro susceptibility data
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announces that three iclaprim abstracts have been accepted for presentation at the upcoming 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018) to be held in Madrid, Spain, April 21-24, 2018.
ECCMID brings together leading experts in the infectious diseases, infection control and clinical microbiology sector to present and discuss the latest results. It is an important arena to showcase Motif Bios iclaprim data.
The title and description of each poster and presentation times are noted below:
1. A phase-3, randomized, double-blind, multicentre study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive bacteria.
Abstract: 286
Session type: Mini oral flash session
Session: Snapshot on pre-registration clinical trials
Date and Time: April 22, 2018, 11:30 AM-12:30 PM
2. Potential cost savings opportunities with targeted iclaprim (ICL) compared to vancomycin (VAN) among hospitalized patients with acute bacterial skin and skin structure infectious due to potential avoidance of VAN-associated acute kidney injury
Abstract: 1290
Session type: Paper poster
Session: Clinical trial experience - new antibacterial agents
Date and Time: April 21, 2018, 3:30-4:30 PM
3. Surveillance of iclaprim activity: in vitro susceptibility of Staphylococcus aureus resistant to clindamycin/tetracycline and beta-haemolytic streptococci resistant to macrolides/ tetracyclines in skin and skin-structure pathogens collected during 2015-2016
Abstract: 204
Session type: Paper poster
Session name: Resistance in various Gram-positives
Date and time: April 23, 2018, 1:30-2:30 PM
Additionally, an abstract on results from a study amongst Veterans Affairs patients related to vancomycin-
associated acute kidney injury in patients hospitalised with ABSSSI will be presented by Tom Lodise, Ph.D., PharmD and colleagues, Albany College of Pharmacy and Health Sciences:
4. Frequency of vancomycin-associated acute kidney injury and healthcare utilization among Veterans Affairs patients with skin and skin structure infections
Abstract: 1287
Session type: ePoster viewing
Session: Various bacterial infections
Date and Time: April 21-24, 2018, 8:45 AM-3:30 PM
For further information please contact:
Motif Bio plc |
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info@motifbio.com | ||
Graham Lumsden (Chief Executive Officer) |
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Walbrook PR Ltd. (UK FINANCIAL PR & IR) |
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+44 (0) 20 7933 8780 / motifbio@walbrookpr.com | ||
Paul McManus/Helen Cresswell/Lianne Cawthorne |
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MC Services AG (EUROPEAN IR) |
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+49 (0)89 210 2280 | ||
Raimund Gabriel |
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raimund.gabriel@mc-services.eu | ||
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The Trout Group (US IR) |
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+1 (646 )378-2963 | ||
Meggie Purcell |
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mpurcell@troutgroup.com | ||
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Russo Partners (US PR) |
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+1 (858) 717-2310 | ||
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+1 (212)845-4272 | ||
David Schull |
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david.schull@russopartnersllc.com | ||
Travis Kruse, Ph.D. |
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travis.kruse@russopartnersllc.com | ||
Note to Editors:
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) 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 hospitalised patients caused by multi-drug resistant bacteria, including MRSA. The Companys lead product candidate, iclaprim, is being developed for high-risk MRSA patient populations. The first proposed indication, and near-term commercial opportunity, is for the treatment of ABSSSI, one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the U.S. The Company believes that iclaprim may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment.
Iclaprim has an underutilised mechanism of action compared to other antibiotics. Clinical and microbiology data indicate iclaprim has a targeted Gram-positive spectrum of activity, low propensity for resistance development, fixed dose administration and favourable tolerability profile. Additionally, data support that the inactive metabolites of iclaprim clear through the kidneys. The Company also 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 was conducted to study iclaprim in patients with HABP. Iclaprim has been studied in an animal model of pulmonary MRSA infection which mimics the pathophysiology observed in patients with cystic fibrosis. Iclaprim has been granted orphan drug designation by the U.S. FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status. Upon acceptance by the FDA of a New Drug Application (NDA), iclaprim will receive Priority Review status and, if approved as a New Chemical Entity, 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.
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 Bios 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 Bios product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bios product candidates, (iii) Motif Bios ability to successfully commercialise its product candidates, (iv) Motif Bios ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bios commercialisation, marketing and manufacturing capabilities and strategy, (vi) Motif Bios expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bios product candidates, (viii) Motif Bios ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, (ix) Motif Bios estimates regarding the potential market opportunity for its product candidates, and (x) the factors discussed in the section entitled Risk Factors in Motif Bios Annual Report on Form 20-F filed with the SEC on May 1, 2017, which is available on the SECs web site, www.sec.gov. Motif Bio undertakes no obligation to update or revise any forward-looking statements.