Motif Bio has released positive Phase III data for a new antibiotic that could be fighting antibiotic resistance in hospitals as soon as 2018.
Motif Bio, based in London, specializes in the development of new antibiotics effective against multi-drug resistant bacteria. Its lead candidate, iclaprim, has just proved in a Phase III trial that it works as well as vancomycin, an antibiotic used to treat life-threatening infections by Gram-positive bacteria that do not respond to other antibiotics.
Iclaprim is effective against high-risk antibiotic resistant bacteria including methicillin-resistant Staphylococcus aureus (MRSA). The antibiotic was tested in patients with acute bacterial skin and skin structure infections (ABSSSI). Its main advantage is that it does not induce nephrotoxicity, making it suitable for the up to 26% of the 3.6 million patients with ABSSSI hospitalized annually in the US that also suffer from kidney disease, according to Motif Bio’s CEO Graham Lumsden.
Motif Bio will now need to complete a second Phase III trial with an identical protocol but conducted at different sites. Results are expected in the second half of this year, and if they are good, the company will submit a new drug application (NDA) for iclaprim to the FDA in the first half of 2018. The FDA had already granted the antibiotic fast track designation, which reflects the great necessity for new treatments against antibiotic-resistant pathogens.
Although promising, iclaprim has been rejected by the FDA before. The regulatory agency required one of its previous owners, Arpida, to conduct an additional efficacy study back in 2009. Since then, the antibiotic has been transferred from one company to another, until Motif Bio acquired it when it merged with Nuprim in 2015.
After struggling with its finances, Motif Bio resurged when it entered the Nasdaq last year, which gave the company enough resources to conduct clinical trials for iclaprim. Thus, paving the way to bring to the market a new product that can address the immensely pressing problems posed by antibiotic resistance.
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