Motif Bio (LON:MTFB) has been given the green light to begin phase III clinical trials on its next-generation antibiotic by the American regulator.
It has achieved this major landmark just weeks after listing on the London market and, dependent funding or finding a partner, work could begin in the second half of the year.
Motif’s drug candidate, iclaprim, is designed to be effective against bacteria that has developed resistance to other treatments.
So there are no surprises that it will at some stage be used to tackle so called Gram positive pathogens such as the hospital-acquired MRSA.
Motif initially wants to gain marketing approval for iclaprim’s use in acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP).
The US Food & Drug Administration has said it must carry out either two ABSSSI studies, or one ABSSSI and one HABP trial.
Motif chief executive Graham Lumsden told investors: “Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilized dihydrofolate reductase inhibitor class, can become an integral part of hospital doctors' life-saving treatment strategies.”
To understand just how Motif finds itself with a phase-III-ready treatment one needs to rewind to 2009 and look at the stop-start development of antibiotics.
Six years ago iclaprim was one of four antibiotics that, having sought the FDA final sign-off, were sent back for further trials.
The watchdog’s cautious approach can be traced back to the 2007 approval of the Sanofi-Aventis antibiotic, KETEK, which was linked to liver toxicity.
It later transpired that much of the KETEK safety data was bogus.
Today, two of the four drugs the FDA sent back for further testing– Dalvance and ORBACTIV - have been put through their paces and are now out on the market, vindicating earlier studies.
The FDA issued the developers with what’s called a Complete Response Letter (CRL) after sending it back for a further phase III trial.
It must be stressed that, for iclaprim at least, no safety concerns were raised in the CRL.
All that was requested in the letter was that another study be carried out that demonstrated the drug’s effectiveness.
The start phase III trials mark an early landmark. Motif is gunning for approval in bacterial skin infection first as it is a common complaint, which means it should be relatively cheap and easy to recruit patients.
However, it is also a crowded space with a number of competing treatments.
That said, iclaprim does have one advantage over the competition – it has a completely different mode of action, which means that hospital formularies should stock it as an alternative to the current gold standard treatment.
It will likely make a more tangible impact in bacterial pneumonia where the current treatment regime means 20-50% of patients die from the medical complication.
The trial for ABSSI is likely to take 18 months and analysts estimate it will cost in the order of £12-£15mln to complete.
The pneumonia study will be more costly and time consuming.
Funding will likely come from an industry partner with deep pockets and the ability to fund iclaprim’s further development; however, Motif might even go it alone, Lumsden told Proactive Investors in a recent interview.
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