At the moment it’s unclear what form the additional assessment will take. The company, in an update, said it had requested a meeting with US Food & Drug Administration to discuss the design of the fresh clinical evaluation, including the appropriate patient population.
Motif is developing iclaprim to treat acute bacterial skin and skin structure infections, and the interaction with the drugs watchdog follows the completion of a phase III trial.
Initial feedback came in the form of a complete response letter following the trial and then from the minutes of a meeting with the FDA on May 3.
Motif chief executive Graham Lumsden said he thought the drug had a future as he mapped out the next steps, while confirming talks with potential commercial partners were ongoing.
“We intend to meet with the agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements,” he explained.
Potential alternative indications
As well as a potential new treatment for hospitalised people with acute skin infections, iclaprim could be developed for use in patients with cystic fibrosis or in ophthalmology under what’s called an orphan indication, CEO Lumsden said.
“Completing the steps necessary to provide the additional trial data to respond to the complete response letter is our top priority,” he added.
“We are also continuing our business development activities to position Motif Bio for long-term growth by building a robust development pipeline.
“In parallel with our focus on iclaprim, we continue to pursue a variety of attractive opportunities in the anti-infectives space, as well as in other key therapeutic areas."
In an update on its finances, the company said it had a cash runway “into September”. Unsurprisingly then, it said it is looking to secure additional cash either via an equity raise through other non-dilutive sources.