Q: How often do we see a small, ambitious UK drugs company hit a home run?
A home run, by the way, is taking a promising drug candidate from the clinic onto the market, something that Motif Bio Plc (NASDAQ:MTFB, LON:MTFB) is close to achieving with its next-generation antibiotic iclaprim.
Iclaprim is being developed initially for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections and hospital-acquired bacterial pneumonia (HABP).
It is also expected to target hard-to-treat conditions caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings.
INSPIRE, a Phase 3 trial designed to study the safety and efficacy of iclaprim in patients with HABP is currently being prepared.
On top of that, Motif is also in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram positive and Gram negative bacteria.
One step closer to commercialisation after latest milestone
The company, which also has a listing on the NASDAQ stock exchange in the US, moved a step closer to potentially commercialising iclaprim after the last patient finished their treatment in the REVIVE-2 Phase III trial.
Data from the study - is investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI) – is due out in the fourth quarter of this year.
Should the results show that iclaprim scored well against the current gold standard treatment, vancomycin – like it did in the REVIVE-1 phase III trial earlier this year – Motif expects the data gathered from both trials is expected to satisfy the European and US regulatory authorities.
Submission of a new drug application (NDA) for iclaprim as a treatment of ABSSSI is anticipated within the first half of 2018.
Has it got the money for that?
In short: yes it does.
Motif raised US$25.8mln back in June which it said it would use to fund the REVIVE-2 trial thorough to completion.
The money will also allow Motif to file for new drug approval and marketing authorisation for the use of iclaprim in patients with ABSSSI.
Chief executive Graham Lumsden said that Motif is “on track to submit an NDA next year”.
City broker: ‘Positive results will lead to significant re-rate’
“The achievement of this clinical milestone known as last patient out (LPO) follows on from a successful US$25.8m fundraise achieved earlier in the year and brings iclaprim a step closer to potential commercialisation,” said finnCap analyst Alex Pye.
“We continue to expect top-line readout within two or three months, with clinical results for REVIVE-2 possibly being available as early as mid-October.”
Pye added: “We retain our 100p target price and ‘buy’ recommendation as of this morning, expecting positive results to significantly re-rate the shares.”
Shares are up 18% so far in 2017, currently changing hands for just under 30p each.