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Pharma & Biotech

Pooled data from phase III trials confirms Motif Bio’s iclaprim drug is safer than gold standard

Pooled data from the REVIVE-1 and REVIVE-2 trials confirmed that iclaprim is non-inferior to vancomycin and significantly safer

New data for Motif Bio Plc’s (LON:MTFB) has confirmed that its next generation antibiotic iclaprim was better tolerated and safer than a rival drug in two recent late-stage studies.

Over the past six months or so, Motif has published top-line data from the phase III REVIVE-1 and REVIVE-2 trials, which showed iclaprim was safe and well-tolerated in patients with acute bacterial skin and skin structure infections (ABSSSI).

READ: Motif closing in on approvals, potentially looking for partners

Having had some extra time analyse the pooled data from the two studies, the AIM-quoted firm has repeated that iclaprim is just as good as (the technical term is ‘non-inferior to’) the current gold standard medication, vancomycin.

Motif also confirmed that iclaprim was safer than vancomycin, with no deaths reported among the iclaprim-treated patients compared to three in the vancomycin group.

The company 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, compared to seven patients in the vancomycin arm.

“Iclaprim has a fixed dose, with no dosage adjustment required in patients with renal impairment or in obese patients, and no kidney toxicity was observed in the REVIVE trials,” said Gary Hock, principal investigator in the REVIVE-2 trial.

“Iclaprim, if approved, may offer advantages over standard of care antibiotics in hospitalised ABSSSI patients, particularly those with renal impairment and/or diabetes.”

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.

No resistance

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 variety of antibiotic-resistant pathogens such as methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) Staphylococcus aureus.

Shares opened 1.8% lower at 31.5p.

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