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Motif Bio preps US filing after antibiotic clears phase III

The UK biopharma hopes to launch iclaprim by early 2019

Antimicrobial resistance

A new antibiotic developed by UK biopharma Motif Bio has hit the mark in a late-stage trial, setting the company’s shares on a surge this morning.

Motif’s lead drug iclaprim – which the company says has a unique mechanism of action – matched the efficacy of the standard-of-care antibiotic vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI) in the REVIVE-2 trial, setting up a regulatory filing in the US next year.

Shares in Motif climbed around 30% on the London Stock Exchange this morning on news of the second positive phase III trial for iclaprim, which keeps the company on course for its target of launching iclaprim onto the market in late 2018 or early 2019. It has previously said it is planning a regulatory filing in Europe in the first half of 2018.

The new drug, a novel diaminopyrimidine that inhibits the bacterial enzyme dihydrofolate reductase, is important as it may provide a new treatment option for Gram-positive bacterial infections that have developed resistance to other antibiotics, including ‘superbugs’ such as methicillin resistant Staphylococcus aureus (MRSA).

There is an urgent need for new antibiotics to counter the rising threat of antimicrobial resistance. Around the world some 700,000 deaths per year are attributed to resistant infections, a figure that’s predicted to rise to 10 million by 2050 if action is not taken.

Aside from its novel mechanism, iclaprim also appears to be free of the kidney-damaging toxicity that can be seen with vancomycin and means that patients on the drug need to be monitored and in some cases have their dose adjusted.

Motif is positioning its drug as a first-line monotherapy that can be administered before the pathogen causing an infection is identified in patients presenting with ABSSSI, and says it could be a candidate for around a quarter of the 3.6 million people who develop this type of infection in the US every year and also have kidney disease.

Ralph Corey Duke University School of Medicine in the US, who was the principal investigator of the REVIVE-2 study, said iclaprim’s fixed dosing and lack of renal toxicity make it an important new therapeutic option for ABSSSI.

“ABSSSI is a serious infection for which patients are frequently hospitalised for several days,” he commented.  “Many of these patients have co-morbidities, such as renal impairment and diabetes [and] for these patients in particular, there is an urgent need for better treatment options.”

Motif is also developing iclaprim for hospital-acquired bacterial pneumonia (HABP), but despite a $24m fundraising in June said recently it would have to raise additional capital to “commercialise and further develop iclaprim and to continue to fund operations.”

The biopharma company acquired iclaprim when it completed a merger with the drug’s former developer Nuprim in 2015. The drug was formerly developed by Arpida AG.

Article by
Phil Taylor

4th October 2017

From: Research

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