viewMotif Bio PLC

Motif Bio boss “very confident” in potential of flagship antibiotic

Motif Bio is working with US regulators as it tries to get approval for iclaprim, while the antibiotic has also shown potential as a treatment for certain lung and eye infections

petri dish
Feedback from the FDA is due at the beginning of June

Motif Bio PLC (LON:MTFB) boss Graham Lumsden is “very confident” in the potential of iclaprim, the drug developer’s next-generation antibiotic.

Iclaprim has already gone through clinical trials as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI).

WATCH: Motif Bio's Graham Lumsden updates on FDA discussions and iclaprim potential

AIM-quoted Motif is currently trying to get US regulators to approve the antibiotic, although they have so far declined to do so, citing the need for additional data on liver toxicity.

Bosses met with Food and Drug Administration officials at the beginning of the month (May) to chart the next steps in the process, and feedback is expected in early June.

Motif has acknowledged that additional data will “likely be required to address the agency’s concern about a risk of liver toxicity”, although it will wait to hear what the FDA has to say before deciding the size and scope of any study.

The plan remains to win marketing approval in the US and then find a partner to help commercialise iclaprim in the States and other global markets.

The company said it is "sufficiently funded" to reach a decision point regarding iclaprim based on the outcome of its meeting with the FDA. Beyond that, it will look at its options to determine the "funding strategy that is most favourable to shareholders".

More than one string to iclaprim’s bow

Some other opportunities have presented themselves of late, though.

Motif has partnered up with Lamellar Biomedical to explore the use of iclaprim as part of a combination treatment for lung infections in people with cystic fibrosis.

The pair will carry out an in vivo study evaluating iclaprim in combination with LMS-611, one of Lamellar’s drugs that has mucus-clearing properties and can boost the performance of antibiotics.

Based on the data from each drug so far, the companies believe combining the two could create a “promising potential treatment” for CF patients with lung infections.

On top of that, Motif thinks its antibiotic has potential as a treatment for toxoplasma chorioretinitis, a rare blindness-causing disease.

It has signed an agreement with the Otto-von-Guericke University Magdeburg in Germany which is to carry out a series of lab tests to see if iclaprim can help people affected by toxoplasma chorioretinitis.

READ: Motif Bio to see if iclaprim can help patients with rare eye disease

“We are very confident in our lead compound Iclaprim's broad potential as a differentiated and targeted anti-infective agent, based on the strong clinical safety and efficacy data we have generated and the important unmet medical and health-economic needs we believe Iclaprim may fulfill within the hospital-based antibiotic landscape and other indications,” said CEO Lumsden.

“In addition to pursuing our first potential approval and commercial partnership for Iclaprim, we are committed to maximizing opportunities to further expand the value of this asset.

“We recently announced two collaborative agreements to evaluate Iclaprim's ability to address high-need orphan diseases within lung disease and ophthalmology.”

Shares were down 6.8% to 6.9p on Wednesday afternoon.

Quick facts: Motif Bio PLC

Price: 0.5 GBX

Market: AIM
Market Cap: £3.27 m

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