Motif Bio Plc (LON:MTFB) hopes to launch its next-generation antibiotic in the first half of 2019 as it waits on the green light from US regulators.
A new drug application (NDA) for iclaprim was filed with the US Food and Drug Administration earlier this year, and a decision is due by February 13 2019.
“Our primary focus is ensuring a successful launch and commercialisation in the first half of 2019, assuming that iclaprim is approved for marketing by the FDA,” said chief executive Graham Lumsden in the half-year report.
Iclaprim safer than current standard of care
The latest data from two phase III studies looking at the effect of the drug on patients with acute bacterial skin and skin structure infections (ABSSSI) showed that the antibiotic just as good as (the technical term is ‘non-inferior to’) the current gold standard medication, vancomycin.
Importantly though, it looks to be safer, especially in obese patients or those with kidney issues.
READ: Data from phase III trials confirms iclaprim is safer than gold standard
In the studies, no deaths were reported among the iclaprim-treated patients compared to three in the vancomycin group.
Motif also repeated that its drug was found not to negatively affect patients’ kidney function, a key issue for some people taking rival treatments.
None of the patients taking iclaprim showed signs of kidney toxicity, whereas seven patients did in the vancomycin arm.
Save hospitals time and money
Motif Bio believes iclaprim can save hospitals, and patients, money by reducing the amount of after-care required for patients who develop kidney complications as a result of taking vancomycin.
At the moment, just over 9% of hospitalised ABSSSI patients treated with vancomycin suffer from vancomycin-associated acute kidney injury, which extends hospital length-of-stay by five days.
Generally, those patients require a specialist nephrology physician consultation and acute dialysis, which can be costly.
More than just ABSSSI?
One key issue with almost all antibiotics is that some bacteria have become resistant to their effects, rendering them useless.
Motif has previously presented data showing that iclaprim still works on a variety of antibiotic-resistant pathogens such as methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) Staphylococcus aureus.
The Cystic Fibrosis Foundation is also funding important in vitro (outside of the body) testing to help develop iclaprim as a treatment for cystic fibrosis patients suffering from lung infections.
“Tremendous” first half
“We made tremendous progress during the first half of 2018, including completing the submission of an NDA with the U.S. FDA for iclaprim in acute bacterial skin and skin structure infections,” said Lumsden.
“We are continuing to build on our achievements and are working to increase awareness and understanding of Motif Bio and iclaprim with potential commercialization partners, the medical community and investors.
“As partnering discussions progress, we continue to evaluate ways to build a team of Medical Science Liaisons, Key Account Managers and Professional Representatives to be able to deliver iclaprim to patients in an effective and efficient manner.”
For the six months ended June 30, Motif posted a net loss of US$7.8mln (H1 17: US$29.7mln), reflecting a big fall in R&D costs.
At the end of the period, the company had US$19.8mln of cash in the bank, compared with US$22.7mln a year ago.