- Iclaprim safety and efficacy in patients with wound infections in REVIVE Phase 3 trials
NEW YORK, Oct. 03, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that iclaprim data are being presented at IDWeek being held in San Francisco, CA, USA October 4-7, 2018. The data show that iclaprim was non-inferior to vancomycin in a pooled analysis of a subgroup of patients in the REVIVE Phase 3 trials who had wound infections. The results are being presented in the Novel Agents poster abstract session on October 5th, 12:30 PM - 1:45 PM PT in poster #1338, A Pooled Analysis of Patients with Wound Infections in the Phase 3 REVIVE Trials: Randomized, Double-blind Studies to Evaluate the Safety and Efficacy of Iclaprim Versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections.
A post-hoc analysis was conducted on the pooled data from the REVIVE-1 and REVIVE-2 Phase 3 trials to evaluate the safety and efficacy of iclaprim compared to vancomycin, the current standard of care, in treating wound infections, including surgical site infections. Fifty percent (602/1198) of the REVIVE intent-to-treat (ITT) population had wound infections. Iclaprim achieved non-inferiority to vancomycin, based on early clinical response at the early time point in the subgroup of patients with wound infections. Iclaprim and vancomycin had similar adverse event profiles in patients with wound infections. Two vancomycin-treated patients and no iclaprim-treated patients had serum creatinine levels ≥3 x upper limit of normal, indicating potential nephrotoxicity, a toxicity known to occur with vancomycin administration.
G. Ralph Corey, MD, Vice Chair for Education and Global Health and Gary Hock Professor at Duke University School of Medicine and a principal investigator in the REVIVE-2 trial, said: “Wound infections, including surgical site infections, can be difficult to treat and it was important to see that iclaprim was non-inferior to standard of care in treating these types of infections. Additionally, in the iclaprim treatment arm, there was no evidence of nephrotoxicity, while two patients in the vancomycin arm demonstrated high serum creatinine levels. Iclaprim, if approved, could be a valuable treatment option for patients with wound infections suspected or confirmed to be due to Gram-positive pathogens, including patients with co-morbidities known to increase the risk of vancomycin-associated acute kidney injury, such as renal impairment, diabetes and obesity.”
The poster will be available in the Development Programs – Publications section of Motif Bio’s website here: www.motifbio.com/publications
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Note to Editors:
Iclaprim is a novel investigational antibiotic with a targeted Gram-positive spectrum of activity. In contrast to commonly used broad-spectrum antibiotics, this “precision medicine approach” is consistent with antibiotic stewardship principles which, among other things, seek to reduce the inappropriate use of broad-spectrum products to avoid the build-up of resistance and to lessen the impact on the microbiome of the patient.
Iclaprim has a different and underutilised mechanism of action compared to most other antibiotics. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. To date, iclaprim has been studied in over 1,400 patients and healthy volunteers. Clinical and microbiological data indicate that iclaprim has a targeted Gram-positive spectrum of activity, low propensity for resistance development and favourable tolerability profile. In the REVIVE 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. Many standard of care Gram-positive antibiotics are not suitable for hospitalised ABSSSI patients with renal impairment due to efficacy and/or safety issues.
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. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is now under review, with a PDUFA date of February 13, 2019. 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 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 recently received. Notices of Allowance from the United States Patent and Trademark Office for two method of use patents 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, and (x) 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.
Motif BioSciences Inc.