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.
And Motif Bio is close to achieving such a feat. After the results from the first of two phase III clinical trials came back positive, the company said it will file for a new drug application for iclaprim in first half of 2018.
The shares, up around 37% in the year to date, advanced 17% Tuesday.
Iclaprim is one of the next-generation of antibiotics and it will be used, initially at least, to treat acute bacterial skin and skin structure infections (ABSSSI).
The top-line results revealed it scored well against one of the leading products, vancomycin, on two counts.
Researchers were assessing whether iclaprim was ‘non-inferior’ to vancomycin 48 to 72 hours after the start of administration and at the test of cure stage, a week to a fortnight after patients stop receiving treatment. It also did well in meeting several secondary ‘endpoints’, investors were told.
Data from REVIVE-2, the second phase III trial that is using an identical protocol but has different trial centres, are expected in the second half of the year.
It is thought iclaprim could be an important treatment for patients with ABSSSI who may have kidney disease – which is around a quarter of the 3.6mln annually that catch the infection.
"The successful completion of REVIVE-1 is a significant achievement for Motif Bio. I would like to thank the patients and physicians that participated in this important study,” said chief executive Graham Lumsden.
Since listing in April 2015, Motif has met an aggressive timetable to get to the point of dosing patients with iclaprim.
- It has obtained regulatory approvals to commence phase III trials
- Raised money to fund the trials
- Appointed Covance to conduct the trials
- Obtained qualified infectious disease product designation, giving iclaprim up to 10 years of US market exclusivity
- Obtained fast-track designation for iclaprim; prepared trial supplies of the drug; and now dosed first patients
- Listed on NASDAQ
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.
Motif is also in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram positive and Gram negative bacteria.
The stock is currently changing hands for 34.17p, valuing the business at just shy of £67mln.
Northland Capital’s Vadim Alexandre, who has a 90p price target, said: “Today’s positive phase III results for iclaprim represent a major milestone.
“The drug was shown to be effective and safe. Consequently, we estimate that Motif’s shares are grossly undervalued.”