logo-loader

Motif Bio gets confirmation of requirements for new iclaprim trial

Published: 08:24 10 Oct 2019 BST

Motif Bio PLC -

Motif Bio PLC (LON:MTFB) has received official confirmation of the parameters of a new trial to get US approval for its iclaprim antibiotic.

Minutes of a Type B meeting between Motif and US Food and Drug Administration in September indicated 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.

Motif Bio repeated that it would take several years to enrol and complete a HABP/VABP Phase III trial and cost tens of millions of dollars hence its decision to either find a partner to pay for the trial or else dispose of iclaprim to a firm with deeper pockets.

The FDA is concerned about possible liver toxicity with iclaprim, something that emerged following the submission of trial data from two phase III assessments of the drug.

Graham Lumsden, chief executive, 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 III trial, commercialise iclaprim and ensure the best outcome for shareholders in Motif Bio."

Chesnara reports strong 2023 results with improved cash generation and...

Chesnara PLC (LSE:CSN) chief executive Steve Murray discusses the company's full-year results for 2023 with Proactive's Stephen Gunnion, describing them as strong and particularly highlighting £53 million in commercial cash generation and a dividend coverage of around 150%. The company has...

1 hour, 19 minutes ago