Motif Bio announced that the results from REVIVE-1, a global Phase 3 clinical trial evaluating the investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI), have been published in the peer-reviewed journal, Clinical Infectious Diseases.The positive topline results from this study were announced in April 2017.  

The ITT study population included 598 randomized patients from clinical trial sites in the U.S., Europe and Latin America. Patients were randomized 1:1 to receive either iclaprim 80mg IV or vancomycin 15 mg/kg IV. Treatments were administered every 12 hours for 5 to 14 days.  

80%  of diabetic patients in the iclaprim group and 74%  of diabetic patients treated with vancomycin achieved ECR at ETP.  83% of iclaprim-treated patients with moderate/severe renal impairment and 75% of vancomycin-treated patients with moderate/severe renal impairment achieved ECR at ETP.

Iclaprim was well tolerated in the study. Treatment emergent adverse events (TEAEs) were generally mild, including headache (10.2% and 2.4%), nausea (9.9% and 5.7%), and fatigue (6.1% and 3.0%), reported in patients in the iclaprim group compared to the vancomycin group, respectively.