New trial required by FDA for iclaprim, for the treatment of acute bacterial skin and skin structure infections

Motif Bio plc announced that the Company has received the official minutes of the Type A meeting the Company held with the FDA on May 3, 2019, to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The minutes indicate that an additional clinical trial will be required prior to granting marketing approval to address the Agency’s continued concerns about potential liver toxicity. The Company has been encouraged by the FDA to put forth a proposal for a future study and to submit it for review. The Company plans to request a meeting with the Agency to discuss the design of the study, including the appropriate patient population to be evaluated.