Motif Bio secures £10m to support antibiotic commercialization efforts

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/scyther5)
(Image: Getty/scyther5)
Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.

Motif Bio plc is a clinical-stage biopharmaceutical company developing novel antibiotics. The company today announced ​the successful completion of a previously announced placing to raise £10.0m ($13.5m).

According to the company, net proceeds of the placing will be used to strengthen its balance sheet and fund near-term regulatory and pre-commercial investments for iclaprim, the company’s novel antibiotic candidate.

Iclaprim is a diaminopyrimidine antibiotic that inhibits dihydrofolate reductase (DHFR) and is administered intravenously.

The company expects to file a new drug application (NDA) with the US Food and Drug Administration (FDA) in the second quarter of 2018. If approved as a new chemical entity (NCE), iclaprim will be eligible for 10 years of market exclusivity in the US.

“This funding, along with our existing resources, allows us to fund some regulatory and pre-commercialization investments for iclaprim and strengthen our balance sheet ahead of entering into more advanced discussions with potential partners to commercialize iclaprim in the US and elsewhere,”​ said Graham Lumsden, CEO of Motif Bio in a statement.

The company is not providing any additional comment at this time.

Developing next-generation antibiotics

The FDA awarded iclaprim fast-track qualified disease product (QIDP) status in 2015​ for the acute bacterial skin and skin structure infections (ABSSSI) and hospital-acquired bacterial pneumonia (HABP).

The designation was provided under the Generating Antibiotic Incentives Now Act (GAIN Act)​ – which has received some criticism​.

Earlier this year, the FDA encouraged Congress to explore potential changes to GAIN​, which was signed into law in 2012 as part of the FDA Safety and Innovation Act (FDASIA)​.

“We continue to explore all aspects of the GAIN incentives to determine if specific changes should, or could, be made,”​ according to the FDA report to Congress​.

The agency has granted​ 147 qualified infectious disease product designations over the past five years, including 74 designations for novel drugs.

Twelve drug products with the qualification have been approved.

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