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Motif Bio makes progress with EU regulators

Published: 11:40 11 Nov 2015 GMT

bacteria
Iclaprim is gunning for new strains of drug-resistant bacteria

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Motif Bio (LON: MTFB) has agreed with regulators what it must submit to gain European Union regulatory approval for iclaprim, its next-generation antibiotic.

It has received written scientific advice from the Medicines Evaluation Board (MEB) in the Netherlands stating its phase-III studies on the treatment, plus microbiological data, should be filed for scrutiny.

Iclaprim is designed to be effective against drug-resistant bacteria, including MRSA.

Motif has brought on board contract research firm Covance to run two phase-III studies on Motif’s lead drug, iclaprim, to assess whether it is better than existing treatment vancomycin for tackling acute bacterial skin and skin structure infections (ABSSSI).

In September, iclaprim received fast-track designation, which means the drug will in all likelihood qualify for a priority review by the US Food & Drug Administration (FDA) when results from its upcoming phase III study are collated.

Motif, which listed on AIM earlier this year, will also be allowed to submit data on a rolling basis.

Drugs are fast-tracked where an illness is serious and life-threatening and where there is an unmet medical need.

Iclaprim has already been awarded qualified infectious disease product (QIPD) status. This means it may be eligible for certain incentives under the new Generating Antibiotic Incentives Now, or GAIN Act. 

Key among them, including fast-tracking with the FDA, is an additional five-year extension of the exclusivity period to sell the antibiotic.

On today’s announcement, the company’s chief medical officer, David Huang, said: "With MEB acceptance of our proposal for two phase III clinical trials for iclaprim, Motif remains firmly on track to meet its goal of completing the two ABSSSI trials in 2017, and submitting a marketing authorisation approval in Europe." 

The shares, listed at 20p in April, marked time at 58p in morning trade.

Broker Northland, reckons there the stock has way further to go.

“This regulatory advice is yet another major milestone for Motif,” explained analyst Vadim Alexandre.

“It ensures that the group’s planned phase III programme is on track to meet its regulatory goals and it paves the way for iclaprim to be licenced in Europe.

“We continue to believe that Motif is grossly undervalued.” 

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