FDA issues CRL for iclaprim, calling for additional data

Clinical-stage biotech firm Motif Bio (AIM: MTFB) today revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI, with the news sending the firm’s shares plunging 71% to 11.60 pence by mid afternoon trading.

The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.

Iclaprim has previously received Qualified Infectious Disease Product designation from the FDA, together with Fast Track Designation. Motif completed its submission of the iclaprim NDA in June last year.