The New Drug Application (NDA) for iclaprim (Motif Bio), a targeted, Gram-positive investigational antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI), has been submitted to the Food and Drug Administration (FDA) for review.

The NDA includes safety and efficacy data from two Phase 3 trials (REVIVE-1 and REVIVE-2; N=1190) which compared intravenous iclaprim to standard-of-care vancomycin in patients with ABSSSI. Pooled data showed that the studies met their primary endpoints of non-inferiority compared with vancomycin at the early timepoint, 48 to 72 hours after treatment initiation. 

With regard to safety, iclaprim was found to be well-tolerated with most patients experiencing only mild adverse effects. Compared with iclaprim-treated patients, those treated with vancomycin had a higher incidence of elevated serum creatinine (0 patients vs 7 patients).

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“Many of these ABSSSI patients have comorbidities, such as renal impairment and diabetes,” G. Ralph Corey, MD, Vice Chair for Education and Global Health and Gary Hock Professor at Duke University School of Medicine and a principal investigator in the REVIVE-2 trial. “For these patients in particular, there is an urgent need for better treatment options. Iclaprim has a fixed dose, with no dosage adjustment required in patients with renal impairment or in obese patients, and no kidney toxicity was observed in the REVIVE trials.”

Iclaprim, a diaminopyrimidine antibiotic, has also received Qualified Infectious Disease Product designation as well as Fast Track designation from the FDA.

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