REVIVE-2 trial of Iclaprim to treat acute bacterial skin and skin structure infections is reported in Antimicrobial Agents and Chemotherapy journal.- Motif Bio plc.

Motif Bio plc has announced that the results from REVIVE-2, a global Phase III 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, Antimicrobial Agents and Chemotherapy. Positive results from this study were announced in October 2017 and presented at the recent 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2018).

The REVIVE-2 study was a global Phase III trial evaluating iclaprim in patients with ABSSSI. As previously reported, the study met its primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure (TOC) endpoint, 7 to 14 days after study drug discontinuation. The ITT study population included 600 patients from clinical trial sites in the U.S., Europe and Latin America. Patients were randomised 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. Baseline and demographic characteristics were comparable between the two groups. More than 40% of patients had wound infections, which are typically more difficult to cure than abscesses and cellulitis. The baseline mean lesion size of patients in the iclaprim arm was 372.3 cm2 compared to 357.0 cm2 in the vancomycin group. The median treatment time for both groups was 7 days (range, 5-14 days). Iclaprim was well tolerated in the trial. There were no study-drug related treatment emergent adverse events related to nephrotoxicity (kidney toxicity) reported for patients treated with iclaprim.

See- Holland, TL et al. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. May 2018 62:e02580-17..