Motif Bio submits meeting request to FDA over iclaprim situation
MOTIF BIO
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08:30 29/07/20
Clinical-stage biopharmaceutical company Motif Bio has submitted a meeting request and package to the US Food & Drug Administration (FDA) related to its lead product candidate ‘iclaprim’, it said on Monday.
The AIM-traded firm said that in the minutes from a 3 May Type A meeting, the FDA indicated that an additional clinical trial would be required prior to granting marketing approval of iclaprim.
It said it had been “encouraged” by the FDA to put forth a proposal for such a study.
Motif Bio confirmed it had requested a Type B meeting with the agency to discuss the proposed study population and design.
It said it would provide guidance on when such a meeting would occur once the FDA issued the meeting granted letter.
The FDA typically scheduled a Type B meeting within 60 days of request, although it could take longer.
“As we take this next step towards potential regulatory approval for iclaprim in the US, I want to recognize the efforts of our dedicated team and our clinical advisors in producing a well-considered submission package to advance our dialogue with the FDA in an expeditious manner,” said chief executive officer Graham Lumsden.
“As we continue our discussions with potential US commercial partners and evaluate potential funding options for the iclaprim clinical programme, we expect to gain greater clarity from the agency during the Type B meeting on the pathway forward for iclaprim.”
Dr Lumsden added that the company’s strategic goal of building long-term shareholder value by establishing a robust pipeline of product candidates continued to be the board’s priority.
“In addition to exploring the use of iclaprim in other disease areas through our recently announced collaborations for cystic fibrosis and chorioretinitis, we are actively evaluating additional in-licensing and asset acquisition opportunities.”