Motif Bio plc announced new iclaprim data are presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases meeting.

Motif Bio plc announced that new iclaprim data are being presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2019) in Amsterdam, The Netherlands.

1.Efficacy analysis by lesion size demonstrates iclaprim had comparable efficacy to vancomycin across broad range of lesion sizes in REVIVE Phase III study patients : Larger-size acute bacterial skin and skin structure infection (ABSSSI) lesions may be more difficult to treat. A post-hoc analysis by lesion size of the pooled data from the REVIVE-1 and REVIVE-2 Phase III trials evaluating iclaprim versus vancomycin for the treatment of ABSSSI patients showed that fixed dosing of iclaprim had similar efficacy results compared to weight/renal function-based dosing of vancomycin across a broad range of lesion sizes, including lesions 800 cm2 or greater.

2. Clearance of bacteremia comparable in patients treated with iclaprim versus vancomycin in pooled analysis of REVIVE Phase III study results: Secondary bacteremia is a complication among patients with ABSSSI and is associated with increased morbidity and mortality. A post-hoc analysis evaluated bacteremia outcomes in patients in the REVIVE trials. There were 12/592 patients in the iclaprim arm and 12/606 patients in the vancomycin arm with secondary bacteremia. In each group, 83% of patients cleared their bacteremia by the test of cure visit (7 to 14 days after end of therapy).

3. Pharmacokinetics of iclaprim support use of fixed dosing regimen in ABSSSI patients: A pharmacokinetic analysis of iclaprim-treated patients in the REVIVE Phase III trials evaluated iclaprim clearance and concentration. Age had a small effect on clearance and with it on AUCi. Clearance decreased by about 10% for each decade over 50 years. Clearance was not affected by weight, gender, renal function, hepatic function or race. There were modest increases related to drug concentration (as measured by AUC and Cmaxii) in patients 65 years and older compared to younger patients, likely due to slower clearance. These differences were not considered clinically meaningful. The results support that no iclaprim dose adjustments are required for elderly patients, nor for obese or renally impaired patients, in this patient population.

4. Recent in vitro data support iclaprim activity against Gram-positive bacteria collected from patients with skin and skin structure infections : Data are being presented that show that iclaprim continues to be active against a variety of antibiotic-resistant pathogens like methicillin-resistant (MRSA), methicillin�susceptible (MSSA) Staphylococcus aureus, and other Gram-positive skin and soft structure pathogens collected during 2017 from Europe and the U.S. �It is important to see that these subgroup analyses in the REVIVE Phase III trials show that results with iclaprim were comparable to vancomycin, even in patients with more challenging-to-treat skin infections, such as those with large lesions or with bacteremia,� said Thomas L. Holland, M.D., MSc-GH, Assistant Professor of Medicine, Duke University School of Medicine. �We continue to need new options to treat patients with ABSSSI, particularly those at risk of vancomycin-associated kidney injury.�

5. Real-world incidence of vancomycin-associated nephrotoxicity in hospitalised patients with ABSSSI shown to be greater than 3-fold higher than in recent trials : Michael J. Rybak, Pharm.D., MPH, Ph.D., Professor of Pharmacy and Medicine, Director, Anti-Infective Research Laboratory, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA led a retrospective, cohort study at two medical centers in Detroit from February to June 2018. A total of 82 hospitalised adults treated with vancomycin (greater than 2 hours) for ABSSSI and with greater than 1 baseline acute kidney injury (AKI) risk factors were evaluated. Patients with severe renal impairment or AKI prior to vancomycin treatment were excluded. The study found that the incidence of nephrotoxicity in patients with greater than 1 AKI risk factor was greater than 3-fold higher than in recent trials, underscoring the importance of close monitoring and/or selection of an alternative agent in at-risk ABSSSI patients.