(Alliance News) - Motif Bio PLC on Thursday said official minutes of its US regulator meeting confirm a phase three trial of iclaprim, plus data on possible liver injury side effects, are necessary to allow submission of a new drug application.
Shares in Motif were down 7.6% at 0.62 pence in London shortly before midday.
Motif got a complete response letter from the US Food & Drug Administration for iclaprim in February, meaning the FDA had completed its review and opted not to approve the drug application in its current form.
The minutes are from a Tube B meeting with the regulator, which took place September 19. These confirmed the need for a single phase three trial, provided it is well designed and well controlled, which shows the safety and efficacy of the drug in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The FDA would also require "data on potential mechanisms of hepatic injury" or injury relating to the liver.
Motif said: "Its would take several years to enrol and complete a HABP/VABP phase three trial and the cost is expected to be tens of millions of dollars."
As such, Motif is confident in its belief "the most efficient way" of generating value from iclaprim is if another partner completes the trial.
Chief Executive Graham Lumsden said: "We now have confirmation of what will be required to progress iclaprim towards a potential approval. The company is working hard to find a partner or other entity to complete the HABP/VABP phase three trial, commercialise iclaprim and ensure the best outcome for shareholders in Motif Bio."
On Wednesday last week, Motif said it planned to raise GBP600,000 through a share placing in order to complete a restructure. This restructure will see Motif turn into a cash shell, winding down operations and selling assets, including iclaprim.
The restructure relieves Motif from its liability and guarantee on an approximately USD6.7 million loan from Hercules Capital Inc, with Hercules taking a perfected security interest in all Motif's intellectual property plus a warrant for 20% of Motif's shares.
By Anna Farley; annafarley@alliancenews.com
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