Minutes of a Type B meeting between Motif and US Food and Drug Administration in September indicated a single well-designed adequate and well-controlled Phase III clinical trial demonstrating safety and efficacy of iclaprim in patients with bacterial pneumonia (HABP/VABP), along with data on potential mechanisms of hepatic injury, would enable submission of a New Drug Application.
Motif Bio repeated that it would take several years to enrol and complete a HABP/VABP Phase III trial and cost tens of millions of dollars hence its decision to either find a partner to pay for the trial or else dispose of iclaprim to a firm with deeper pockets.
The FDA is concerned about possible liver toxicity with iclaprim, something that emerged following the submission of trial data from two phase III assessments of the drug.
Graham Lumsden, chief executive, said: "We now have confirmation of what will be required to progress iclaprim towards a potential approval.
"The company is working hard to find a partner or other entity to complete the HABP/VABP Phase III trial, commercialise iclaprim and ensure the best outcome for shareholders in Motif Bio."