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Motif Bio PLC calls time on iclaprim

Snapshot

Motif is confident there is a path to market for iclaprim, it will require a company with deeper pockets to take the putative treatment further.

antibiotic

Quick facts: Motif Bio PLC

Price: 0.4825 GBX

AIM:MTFB
Market: AIM
Market Cap: £2.34 m
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  • Motif Bio is to sell antibiotic iclaprim after FDA setback 

  • US regulator requested new trial after concerns over toxicity

  • Company will wind down US business

 

What next?

Motif says a new trial for iclaprim will cost tens of millions of dollars.

Instead, it is proposing to sell iclaprim, its main asset, as part of a root and branch reorganisation of the company.

The drug developer had been talking with the US regulator following queries over its phase III clinical trial.

Minutes of a Type B meeting between Motif and  Food and Drug Administration in September have been published.

They reveal a single well-designed adequate and well-controlled Phase III clinical trial demonstrating safety and efficacy of iclaprim in patients with bacterial pneumonia (HABP/VABP), along with data on potential mechanisms of hepatic injury, would enable submission of a New Drug Application.

And while Motif is confident there is a path to market for iclaprim, it will require a company with deeper pockets to take the putative treatment further.

“It would take several years to enrol and complete a HABP/VABP phase III trial and the cost is expected to be tens of millions of dollars,” said CEO Graham Lumsden.

“We believe that the most efficient way to generate future value from iclaprim is for a partner or other entity with a lower cost of capital to complete the HABP/VABP Phase III trial and commercialise the asset globally.”

 

Fundraising

Shortly after Motif announced the plans for iclaprim, it conditionally raised £600,000 to facilitate the restructuring.

Shareholders will also be asked to grant secured lender Hercules Capital a warrant over 20% of the group’s share capital following the placing and to reorganise the company’s share capital.

Placing shares were priced at 0.42p.

Market price at the time was 0.68p, which values the business at £2.1mln.

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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

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