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
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.”
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.