viewMotif Bio PLC

Motif Bio PLC requests meeting with US regulator to discuss trial design

It has made the request after being encouraged by the US Food & Drug Administration to carry out further work on flagship drug iclaprim

FDA graphic
A follow-up study could be the key to gaining marketing approval for the company's antibiotic

Motif Bio PLC (LON:MTFB) has requested a second meeting with the US drug regulator as part of its bid to win marketing approval for its antibiotic, iclaprim.

The company has been asked by the Food & Drug Administration to perform a further clinical trial before it signs off the drug.

Motif therefore wants to arrange what’s called a Type-B meeting with the watchdog to discuss just which types of patient will take part in the new study along with its design.

It typically takes around 60 days from the time of request to schedule a face to face of this kind.

Along with the request, the company has also submitted an information package.

Motif chief executive Graham Lumsden said: “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."

The FDA in an earlier discussion encouraged Motif to carry out a further trial to allay concerns over liver toxicity, which emerged following the submission of trial data from two phase III assessments of the drug.

Quick facts: Motif Bio PLC

Price: 0.5 GBX

Market: AIM
Market Cap: £3.27 m

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