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Motif Bio : The home plate beckons

US Food & Drug administration approval is yet to be granted but iclaprim, which has fast-track status, is closing in on the promised land.
Antibiotics
Patients are increasingly showing resistance to the effects of competing antibiotic vancomycin

Motif Bio Plc (LON:MTFB) on Wednesday came a step closer to crossing home plate with its lead product, a next-generation antibiotic called iclaprim.

For the early results of second phase III clinical study, called REVIVE-2, revealed the medication was both effective and well tolerated.

Northland Capital’s Vadim Alexandre said the company had passed its biggest milestone to date, putting it on course to make a new drug submission in the first quarter next year.

WATCH: Motif Bio on track to move forward with new drug application after Iclaprim success

If all goes to plan, the market launch of iclaprim, which is also being developed for other indications such as hospital acquired infections, should take place in the second half of 2018.

The shares shot up 41% to 51.69p, valuing Motif at £136mln. But that might not capture the full potential of Motif’s breakthrough.

Northland’s Alexandre pointed out that when benchmarking Motif it might be worth using as a reference Paratek Pharmaceuticals, which is listed on NASDAQ and has a drug similar to iclaprim coming to market.

WATCH: The 'end of the marathon' for Motif Bio's Iclaprim

The Americans, who tend to be a little punchier with their valuations, think it is worth US$700mln, or £527mln.

The small-cap broker, finnCap, certainly thinks there’s some upside to the current share price with its £1 a share price target, which would get Motif to the quarter of a billion pound mark

We’ll have to wait to see if there is a re-rating and just how far into the stratosphere this takes us, but all the ingredients are there.

So what exactly has happened?

Well we received what is called top-line data from the REVIVE-2 trial – that’s the bare-bones result from a months’ long study.

The trial pitted Motif’s iclaprim treatment against vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI).

The intent was to show that iclaprim was just as good as (the technical term is non-inferior to) the gold standard medication. The results did just that.

Chief executive Graham Lumsden said the positive outcome was “testament to the incredible efforts of our team at Motif who have worked tirelessly to get us to this stage”.

“We believe that these results validate our belief in iclaprim as a potential new antibiotic candidate for patients with serious and life-threatening infections. I thank the patients and clinicians who participated in this important study,” he added.

Valuable asset

If approved, the antibiotic will be an important new option for patients with ABSSSI, especially those who may also have kidney disease.

This could apply to just over a quarter of the 3.6mln people annually who contract the acute skin infection in the US.

“Unlike current standard of care antibiotics, in clinical trials to date, kidney toxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment,” said Lumsden.

“Iclaprim may be an important option for the growing population of patients with ABSSSI and kidney disease who need a safe and effective antibiotic targeting Gram-positive bacteria, including MRSA."

As mentioned above, this wasn’t the first phase III assessment successfully completed by Motif.

Potential partnerships?

REVIVE-1 was an identical study, but used different trial centres. It also rubber stamped the potential of iclaprim in patients with ABSSSI.

Results from the first cohort also revealed it as a potential alternative treatment for those with kidney disease, which could end up being a a huge selling point.

“[There are] unique clinical benefits aimed at prescribing clinicians that will, in our opinion drive iclaprim adoption at an accelerated pace,” said finnCap analyst Alex Pye.

“Fixed dosage and renal sparing make a very compelling prescribing argument for treating patients with iclaprim over vancomycin, which increasingly shows signs of developing resistance.”

Pye pointed out that Motif may be approached by larger pharmaceuticals companies who would look to sell the new product through their established sales networks and hospital contacts.

He said this could drive market share gains beyond the 15% being predicted by the market.

The finnCap number cruncher is sticking with his £1 a share valuation – for the time being - as US Food & Drug administration approval is yet to be granted.

“But given iclaprim’s fast track status and potential appeal to clinicians, we believe that the long term prospects of the antimicrobial are robust,” he added.

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