The US regulator has told Motif Bio that a “single well-designed adequate and well-controlled Phase III clinical trial” for iclaprim would be sufficient to move forward with a New Drug Application (NDA), the company said.
The company said it was looking for a partner with a “lower cost of capital,” to help complete the Phase III program, and to commercialise the asset globally.
The trial will seek to demonstrate safety and efficacy of iclaprim in patients with HABP, including VABP, along with data on potential mechanisms of hepatic injury.
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