Motif Bio is to hold new trial for antibiotic iclaprim after FDA setback
US regulator requested trial after concerns over toxicity
Company is looking at new areas where iclaprim can be an effective treatment
What the company does:
Motif Bio PLC’s (LON:MTFB) (NASDAQ:MTFB) lead drug candidate is iclaprim, a next-generation antibiotic for which it was seeking Food & Drug Administration approval for use in patients with acute bacterial skin and skin structure infections (ABSSSI).
On February 14, the American watchdog said it wouldn’t be giving the regulatory green light. Unsurprisingly, the share price dropped sharply.
Motif will meet the US regulators on 19 September to discuss what is needed from the new trial to gain sign-off for iclaprim.
Minutes from the Food & Drug Administration Type B are expected 30 days later, after which the company will update the market.
So what’s the problem?
The FDA wants additional data so it can “further evaluate the risk for liver toxicity” before it decides to grant new drug approval.
As one of Motif’s advisers pointed out, this wasn’t a straight ‘no’, so there may still be some hope.
In June, Motif released new data for its iclaprim antibiotic at a major industry conference in San Francisco, California.
Three posters were presented at the American Society for Microbiology (ASM) Microbe 2019 meeting.
In August, Motif revealed that it was assessing the potential for iclaprim as a treatment for the life-threatening infection Listeria.
Partner JMI Laboratories will use pre-clinical services provided by National Institute of Allergy and Infectious Diseases, to assess the antibiotic.
iclaprim at a glance
Well-differentiated antibiotic candidate for serious and life-threatening Gram-positive infections in hospitalised patients.
Intended follow-on indications for hospital-acquired bacterial pneumonia (HABP) and staphylococcus lung infections in patients with cystic fibrosis.
At 2.56p, Motif is valued at £8.4mln.