Motif Bio Announces Results of Two Posters on Iclaprim at ID Week 2015
Dr. David Huang, Chief Medical Officer at Motif, commented: "Data from these studies provides us with further confidence that iclaprim can perform well in the two Phase III trials in ABSSSI. Furthermore, the Phase II data in nosocomial pneumonia caused by Gram-positive bacteria, which are commonly identified as Staphylococcus aureus, including MRSA, provides good evidence that iclaprim may also be successful in our planned Phase III clinical trials to treat hospital-acquired and ventilator-associated bacterial pneumonia."
The two posters:
(1) "Cessation of Spread of Lesion and Absence of Fever at 72 hours in Complicated Skin and Skin Structure Infection (cSSSI): Reanalysis of the Combined ASSIST Phase III Study Comparing Iclaprim and Linezolid."
This poster presented data on the reanalysis of two Phase III studies to treat cSSSI comparing iclaprim to linezolid, a standard of care treatment for SSSI, using endpoints similar to those based on the US Food and Drug Administration's (FDA) recently changed guidelines for ABSSSI trials.
In the first Phase III study, patients who received iclaprim and linezolid had an early clinical response, defined as cessation of lesion spread and fever resolution at 72 hours of 73.9% and 71.4%, respectively: difference 2.5%; 95% confidence interval -5.6% to 10.6%.
In the second Phase III study, patients treated under the same treatment regimen had an early clinical response of 73.3% and 73.7%, respectively: difference -0.4%; 95% confidence interval -8.4% to 7.7%.
These data show that iclaprim achieved a high rate of early clinical response among patients with cSSSI.
(2) "Randomized, Double-Blind, Multicenter Phase II Study to Evaluate Efficacy and Safety of Intravenous Iclaprim versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed Caused by Gram-positive Pathogens."
This poster presented data on outcomes related to treatment with iclaprim compared to vancomycin, a standard of care treatment for Hospital-acquired bacterial pneumonia (HABP), ventilator-associated pneumonia (VAP) and healthcare-associated pneumonia (HCAP).
Patients who received a low dose of iclaprim, a high dose of iclaprim, and vancomycin had a clinical cure rate of 73.9%, 62.5%, and 52.2%, respectively. Under the same treatment regime patients had a Day 28 mortality rate of 8.7%, 12.5%, and 21.7%, respectively.
These data show that iclaprim had high clinical cure rates and relatively low mortality rates among patients with HABP, VAP, and HCAP.