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.
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.