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Motif Bio Presents New Pre-Clinical Data for Iclaprim at IDWeek 2017™1. Pre-Clinical Data Support the Potential Use of Iclaprim in the Treatment of Staphylococcus aureus Pneumonia in Cystic Fibrosis Patients 2. Iclaprim Demonstrates Potent In Vitro Suppression of Exotoxins in MRSA Isolates NEW YORK, Oct. 06, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc ("Motif Bio" or the "Company") (AIM:MTFB) (NASDAQ:MTFB), a clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced that new pre-clinical data with its investigational drug candidate iclaprim were presented today during the IDWeek 2017™ conference, held in San Diego, CA, 4-8 October 2017. Efficacy Evaluation of Iclaprim in a Neutropenic Rat Lung Infection Model with Methicillin-Resistant Staphylococcus aureus Entrapped in Alginate Microspheres (Poster #1525) Dr Huang commented: “Following the recently announced positive, top-line Phase 3 REVIVE-2 clinical trial results for iclaprim for acute bacterial skin and skin structure infections (ABSSSI), the data presented today at IDWeek underscore the potential utility of iclaprim in a range of patient populations with suspected MRSA infections, including cystic fibrosis patients with Staphylococcus aureus lung infections. Staphylococcus aureus is a common cause of pneumonia in patients with cystic fibrosis and we do not believe that any antibiotic has been approved for this indication. Some 80% or more of patients with cystic fibrosis die as a result of respiratory infections caused by a variety of bacteria, and MRSA infections have been growing in recent years. The encouraging new data presented today support developing iclaprim as a potential treatment option for MRSA infections in patients with cystic fibrosis, and iclaprim was recently granted Orphan Drug Designation in the U.S. for Staphylococcus aureus lung infections in this patient group.” Effects of Iclaprim and Trimethoprim on Exotoxin Production by Methicillin-Resistant Staphylococcus aureus (Poster #1219) Dr. Huang said: “Toxin suppression is an important therapeutic goal for severe infections due to toxin-producing Gram-positive pathogens such as MRSA. The in vitro data presented show that Iclaprim, at concentrations below those that inhibit bacterial growth, suppress toxin production. Iclaprim is 15-fold more active than trimethoprim, supporting the use of iclaprim to treat serious MRSA infections in hospitalised patients.” For further information, please contct:
Notes to Editors IDWeek 2017™ IDWeek 2017™ is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The annual meeting is attended by more than 6,000 healthcare professionals practicing or involved in infectious diseases and healthcare epidemiology and prevention, including researchers, clinicians, quality and patient safety practitioners, and epidemiologists. It is a recognized forum for peer-reviewed presentations of new research on scientific advances and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. About Iclaprim Iclaprim is a novel investigational antibiotic that has a different and underutilised mechanism of action compared to other antibiotics. Iclaprim exhibits potent in vitro activity against gram-positive clinical isolates of many genera of staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA). Iclaprim is rapidly bactericidal, achieving 99.9% in vitro kill against MRSA within 4 to 6 hours of drug exposure versus 8 to 10 hours for vancomycin. To date, iclaprim has been studied in over 1,300 patients and healthy volunteers. In clinical studies iclaprim has been administered intravenously at a fixed dose with no dosage adjustment required in patients with renal impairment or in obese patients. The iclaprim fixed dose may, if approved, 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 patients with renal impairment. About Motif Bio Motif Bio plc (AIM:MTFB) (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 Company’s 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 acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the US. 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 chronic pulmonary MRSA infection which mimics the pathophysiology observed in patients with cystic fibrosis. Results from this study were presented at IDWeek 2017™ on 6 October 2017 in San Diego, CA. 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 data exclusivity is anticipated. Forward-Looking Statements |