Motif antibiotic secures special status from FDA
UK company Motif Bio has gained an FDA special status for its pipeline novel antibiotic, which will help secure the drug’s commercial future when and if it is approved.
The US Food & Drug Administration (FDA) has designated iclaprim, the firm’s broad-spectrum antibiotic against multi-drug resistant bacteria, as a Qualified Infectious Diseases Product (QIDP) for hospital acquired bacterial pneumonia (HABP).
Gaining this status was the final condition of a £22 million share placement funding from institutional investors, which means the firm can now invest the cash in developing its lead candidate.
QIDP designation is part of the US regulator’s GAIN Act, aimed at incentivising the development of novel antibiotics in areas of greatest need. Iclaprim is now eligible for incentives such as priority review and fast track designation. QIDP designation also means that iclaprim is eligible for an extra five-years of US market exclusivity, giving a total of 10 years of exclusivity from the date of approval.
Graham Lumsden, chief executive of Motif Bio said: “QIDP designation for iclaprim for HABP is an important step in continuing to build the value of iclaprim and is another positive for Motif and our investors. We believe that iclaprim is the first and only dihydrofolate reductase inhibitor to receive QIDP designation.”
Lumsden added that the firm was delighted to have secured the funding from its investors, and said it could now proceed to commencing phase III trials for iclaprim and other molecules in its portfolio.
The company is part of a wave of firms now responding to the need for a new generation of novel antibiotics, as warnings of a potential antimicrobial resistance (AMR) ‘apocalypse’ grow.
The firm is also among the UK firms benefitting from a resurgence in funding and investor confidence in the biotech sector, having debuted on the London Stock Exchange’s AIM market earlier this year.
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