FDA agrees to Phase 3 clinical development programme of breakthrough antibiotic iclaprim

The U.S. Food and Drug Administration (FDA) has agreed to the proposed Phase 3 clinical development programme for Motif’s lead product candidate, iclaprim.

The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as MRSA (methicillin-resistantStaphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae).

Phase 3 trial of iclaprim expected to commence later this year

The FDA confirmed that two ABSSSI trials or one ABSSSI trial plus one HABP trial meeting their pre-specified primary endpoints are required for approval of iclaprim.  Motif is working to determine the costs and timeline of these options. Assuming that funds can be raised or a partnership can be entered into, the first Phase 3 trial for ABSSSI is expected to commence in the second half of 2015.

Iclaprim is a novel, next generation diaminopyrimidine derivative belonging to the class of selective dihydrofolate reducatase (DHFR) inhibitors and is an antibiotic designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim.

Iclaprim has exhibited potent in-vitro, bactericidal activity against Gram-positive pathogens and, based on in-vitro data, has a low propensity for the development of resistance. It has an established safety and efficacy profile and IV formulations of iclaprim have been compared to vancomycin and linezolid in clinical studies in more than 560 patients with complicated skin and skin structure infections (“cSSSI”) and approximately 50 patients with hospital acquired bacterial pneumonia (“HABP”).

Graham Lumsden, CEO of Motif, commented: “We are pleased to confirm the positive results of our meeting with the FDA and are moving forward with our plans to initiate the Phase 3 clinical development programme for iclaprim in 2015.   The programme will investigate the safety and efficacy of iclaprim in patients with ABSSSI and HABP, two serious and life threatening infections caused by multi-drug resistant bacteria.  Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilized dihydrofolate reductase inhibitor (DHFRi) class, can become an integral part of hospital doctors’ life-saving treatment strategies.”

For more information about Motif Bio plc, please visit www.motifbio.com.