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Motif Bio PLC

Motif Bio seeks talks with US drugs regulator

Snapshot

Motif’s lead drug candidate is iclaprim, a next-generation antibiotic for which it was seeking US FDA approval for use in patients with acute bacterial skin and skin structure infections

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Quick facts: Motif Bio PLC

Price: £0.02

Market: AIM
Market Cap: £7.88 m
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• Motif Bio seeking talks with FDA after recent drug setback 

• US regulator has requested more data on antibiotic iclaprim

• In cash conservation mode after repaying a tranche of a loan

 

What the company does: 

Motif Bio PLC’s (LON:MTFB) (NASDAQ:MTFB) lead drug candidate is iclaprim, a next-generation antibiotic for which it was seeking Food & Drug Administration approval for use in patients with acute bacterial skin and skin structure infections (ABSSSI). On February 14, the American watchdog said it wouldn’t be giving the regulatory green light. Unsurprisingly, the share price dropped sharply.

What next?

Motif is keen “to discuss potential options to address the deficiencies” with the information it had furnished. According to chief executive Graham Lumsden, the team may have to wait between 30-45 days before having the opportunity to do so.

So what’s the problem?

The FDA wants additional data so it can “further evaluate the risk for liver toxicity” before it decides whether or not to grant new drug approval. As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’. So there may still be some hope.

Cash is key

Motif said it will manage its cash aggressively after announcing plans to immediately repay a US$7mln tranche of a loan it has taken out. It also signalled it will have to quickly raise funds after being left with just US$3mln in cash following the payment to Hercules Capital. It still owes US$7.7mln to Hercules.

What now?

“The company is currently assessing the options available to it to raise sufficient capital to provide cash runway to enable it to meet the FDA and discuss options to advance iclaprim towards approval,” Motif told investors on February 18.

iclaprim at a glance

Well-differentiated antibiotic candidate for serious and life-threatening Gram-positive infections in hospitalised patients.

Intended follow-on indications for hospital-acquired bacterial pneumonia (HABP) and staphylococcus lung infections in patients with cystic fibrosis.

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Watch

Motif Bio completes rolling submission of NDA for new antibiotic Iclaprim

Graham Lumsden, chief executive of Motif Bio Plc (LON:MTFB), tells Proactive's Andrew Scott they've completed a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for their new antibiotic Iclaprim. Lumsden says upon acceptance of the filing of...

on 18/6/18

2 min read