Motif Bio to Present Iclaprim Data at ASM Microbe 2019
NEW YORK, May 21, 2019 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announced today that three iclaprim abstracts have been accepted for presentation at the upcoming American Society For Microbiology (ASM) Microbe 2019 meeting to be held in San Francisco, CA, USA, June 20-24, 2019. The abstracts are now available online on the ASM website at https://asm.org/Events/ASM-Microbe/Home
Details for each poster are noted below:
1. Iclaprim Use across Various Subpopulations Treated for Bacterial Skin and Skin Structure Infections
Session type: PosterSession: P403 - CIV01 - Clinical Studies of Adult Infectious Diseases: Treatment of Drug-resistant Infections Date and presentation time: June 21, 2019, 11 AM-12 PM and 4-5 PM
2. Population Pharmacokinetic (PK) Analysis of the Fixed Dose of Iclaprim in the Phase 3 REVIVE Studies for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Session type: PosterSession: P403 - CIV01 - Clinical Studies of Adult Infectious Diseases: Treatment of Drug-resistant Infections Date and presentation ime: June 21, 2019, 11 AM-12 PM and 4-5 PM
3. Surveillance of Iclaprim Activity against Multi-Drug Resistant Streptococci Collected from Patients with Skin and Skin Structure Infections from 2013-2017 from Locations Worldwide
Session type: PosterSession name: P515 - AAR09 - Pharmacological Studies of Novel Investigational Agents (Phase 2/3) Date and presentation time: June 22, 2019, 11 AM-12 PM and 4-5 PM
For further information please contact:
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Note to Editors:
About Motif Bio
Motif 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 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.
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 15, 2019, 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.