2016 was a fairly momentous year for Motif Bio (NASDAQ:MTFBF, LON:MTFB) on both the pharmaceutical and financial fronts.
In March, it passed a major milestone when it dosed its first patient in one of two phase III clinical trials it is carrying out on its next-generation antibiotic, iclaprim.
It completed its long-mooted listing on Nasdaq where, some would argue, pharmaceutical companies (and how to value them) are better understood.
That coincided with a US$25mln fund-raising, which will be used to complete the REVIVE-1 phase III clinical studies of iclaprim.
The studies will assess the drug’s potential in treating acute bacterial skin and skin structure infection, a life threatening condition.
They will look at efficacy and safety and compare them with the standard treatment vancomycin.
In all 1,200 patients will take part in the global trials run by Motif’s partner Covance.
Researchers are hoping iclaprim can deliver at least a 20% reduction in lesion size in two to three days.
The secondary, but key goal is a clinical cure at one to two weeks after treatment.
The trials are expected to be completed by the second half of 2017.
“Iclaprim has the potential to be a major addition to the armamentarium of antibiotics much needed for the treatment of serious and life-threatening infections caused by multi-drug resistant bacteria in hospitalised patients," said Motif chief executive Graham Lumsden.
Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP).
This includes 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.
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
From the boss
Graham Lumsden, chief executive, speaking to Proactive’s Juliet Mann:
“The comparative antibitioic is called Vancomycin and that is used today in up to 80% of patients in hospitals with some of these nasty infections, so we think it is the right competitor to use, because it is the standard of care today.”
On iclaprim’s comparison to vancomycin…
“Iclaprim has been compared to vancomycin in two Phase II trials and looks really effective compared to vancomycin, so we are very confident for our Phase III programme that we have just embarked upon.”
On the trial’s progress…
“I think it is great news for investors because it keeps us on track with what we have been promising to get the trials underway and to complete them in the second half of 2017.”
What the broker says
Northland Capital has a price target 114p, versus a current share price in London of around 25p.
“Iclaprim is set to fill a major market void in the wake of a global public health crisis driven by rampant antibiotic resistance,” said Northland Capital analyst Vadim Alexandre in a note to clients.
“Completing a NASDAQ listing represents another milestone for Motif,” he added.
Recently, the company added someone with strong experience in private and public healthcare companies in the US with the appointment of Robert Dickey as its new chief financial officer.
“Robert is a strong addition to the Motif team, particularly due to his considerable experience in the biotech sector. Also, his NASDAQ experience will prove useful to the company given its recent dual-listing on the market,” suggested Alexandre.