The company, which is scheduled to meet the US Food and Drug Administration (FDA) in early May to discuss concerns over the risk of liver toxicity for patients taking iclaprim, stressed that securing US approval is but part of a broader plan for iclaprim's long-term success.
“We expect to be joined at the meeting by two external experts and anticipate a collaborative discussion and hopefully an acceptable path forward. We believe that iclaprim can be a valuable option for patients and their providers who are in need of new antibiotic treatment options,” said Dr Graham Lumsden, the chief executive officer of Motif.
In the meantime, the company is keeping a tight watch on costs, having posted a sharply reduced loss of US$14.0mln for 2018 compared to a loss of US$44.8mln in 2017.
Research and development expenses decreased to US$11.0mln from US$29.5mln in 2017. This decrease was primarily attributable to a US$22.1 million reduction in expense for the iclaprim Phase III clinical trial programme, which was completed in 2017, although this was partially offset by a US$3.6mln increase in costs relating to regulatory and clinical operating activities, chemistry manufacturing and control requirements and other non-clinical development activities.
Cash and cash equivalents stood at around US$12.3mln at the end of 2018; since then, the company has raised US$3.3mln through a share issue.
Way forward for iclaprim
As previously mentioned, the company has enough money to get it beyond the meeting with the FDA next month and tide it over while it formulates a plan for the way forward for iclaprim after the meeting.
In a note to clients, analysts at ‘house’ broker Peel Hunt pointed out: “Our forecasts, recommendation and TP remain U/R and we await the company’s perspective following the FDA meeting on 3 May where it will discuss the points raised in the complete response letter (received 14 February) for iclaprim’s NDA.”
They added: “We note that the company has previously described that – assuming a viable route to approval can be found beyond the FDA meeting – it expects further funds to be required to resubmit an NDA, meet all obligations and reach a new approval date.”
In afternoon trading, Motif Bio shares were trading at 8.68p, down 1% on Friday’s close.
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