Shares in Motif Bio PLC (LON:MTFB, NASDAQ: MTFB) soared 31% in opening deals after its lead drug, a next generation antibiotic, successfully negotiated a crucial final-stage clinical study.
The REVIVE-2 Phase III trial pitted Motif’s iclaprim treatment against vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI).
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The intent was to show that iclaprim was just as good as (the technical term is non-inferior to) the gold standard medication.
The top-line results showed just that, as well as revealing the Motif antibiotic course was well tolerated by patients who took it.
The company will now lodge a new drug application with US regulators in the first quarter of next year, the company said in a statement.
Testament to Motif team's efforts
Chief executive Graham Lumsden said the positive outcome was “testament to the incredible efforts of our team at Motif who have worked tirelessly to get us to this stage”.
“We believe that these results validate our belief in iclaprim as a potential new antibiotic candidate for patients with serious and life-threatening infections. I thank the patients and clinicians who participated in this important study,” he added.
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If approved the antibiotic could be an important option for patients with ABSSSI, especially those who may also have kidney disease.
This could apply to just over a quarter of the 3.6 mln people annually who contract the acute skin infection in the US.
“Unlike current standard of care antibiotics, in clinical trials to date, kidney toxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment,” said Lumsden.
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“iclaprim may be an important option for the growing population of patients with ABSSSI and kidney disease who need a safe and effective antibiotic targeting Gram-positive bacteria, including MRSA."
At 8.25am, the shares were up 11.51p at 48.26p.
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