Iclaprim Gets Priority Review for Acute Bacterial Skin/Skin Structure Infections

Iclaprim is an investigational diaminopyrimidine antibiotic
Iclaprim is an investigational diaminopyrimidine antibiotic

Motif Bio announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for iclaprim with Priority Review as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI)

Iclaprim is an investigational diaminopyrimidine antibiotic with a targeted Gram-positive spectrum of activity and a distinct mechanism of action demonstrated by rapid bactericidal activity in vitro; it works by inhibiting the dihydrofolate reductase (DHFR) enzyme. Clinical data has indicated that the drug exhibits a low propensity for resistance development as well as a favorable tolerability profile. In clinical trials, iclaprim was administered intravenously at a fixed dose; no dosage adjustments were needed in patients with renal impairment or obesity.

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The NDA contains data from the Phase 3 REVIVE-1 and REVIVE-2 trials which evaluated iclaprim in the treatment of ABSSSI. Iclaprim achieved the primary endpoint of non-inferiority (10% margin) vs vancomycin (current standard of care) at the early time point, 48–72 hours after start of administration of the study drug (REVIVE-1: -0.13% difference; REVIVE-2: 1.58% difference). Also, iclaprim achieved non-inferiority (10% margin) at the test of cure endpoint, 7–14 days after discontinuing the study drug.

The FDA has previously designated iclaprim as a Qualified Infectious Disease Product (QIDP). Motif Bio also plans to evaluate iclaprim for hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP). Iclaprim has also been granted Orphan Drug Designation for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis. 

A Prescription Drug User Fee Act (PDUFA) target date has been set for February 13, 2019.

For more information visit MotifBio.com.