Shares in UK-based antibiotics developer Motif Bio (AIM: AMP) are now worth just a tenth of their value of four months ago after more bad news about iclaprim, the company’s lead product.
Motif Bio has received the official minutes of the Type A meeting that it held with the US Food & Drug Administration (FDA) on May 3, to discuss the Complete Response Letter (CRL) related to the New Drug Application for iclaprim, for the treatment of acute bacterial skin and skin structure infections.
The minutes confirm that an additional clinical trial will be required prior to granting marketing approval to address the agency’s continued concerns about potential liver toxicity.
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