Motif Bio Presents New Iclaprim Data at ECCMID 2019
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.
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).
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.
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
“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
Real-world incidence of vancomycin-associated nephrotoxicity in hospitalised patients with ABSSSI shown to be >3-fold higher than in recent trials
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Note to Editors:
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
Iclaprim received Qualified Infectious Disease Product (QIDP) designation from the
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.
i AUC – Area under the curve: Mathematical method for measuring drug concentrations.
ii Cmax – Maximum concentration: The peak concentration that a drug achieves in the body after the drug has been
administered and before administration of a second dose.