“Iclaprim is now eligible for 10 years of market exclusivity”
Five questions to Graham Lumsden, CEO of Motif Bio
Motif (LSE:MTFB) is addressing an urgent need for new antibiotics with a large market opportunity. Iclaprim has a unique mode of action, safety and efficacy was demonstrated in previous Phase III clinical trials and Motif is close to value shifting events. On top of this, there is a real drive from both regulatory bodies and industry to approve and in license new antibiotics, respectively.
GoingPublic: Motif is developing iclaprim as an antibiotic, why, when there are so many other antibiotics already approved?
Graham Lumsden: Antibiotic resistance has become a global health crisis, due to overuse and a lack of underinvestment by the healthcare sector, combined with previous regulatory intransigence. Today this has changed with recognition of the urgency to find new antibiotics. With iclaprim, our lead antibiotic, we will be addressing serious and life threatening hospital infections, especially infections caused by antibiotic-resistant bacteria, such as MRSA.
So what is different about iclaprim compared to other antibiotics?
Iclaprim is a rapidly acting antibiotic that kills bacteria by selectively binding to and inhibiting dihydrofolate reductase (DHFR). The DHFR enzyme is vital for the survival of bacteria. The antibiotic has shown in vitro that it can reduce bacterial load by 99.9% in six hours. The DFHR inhibition and the rapid response are considered to be critical for treating patients with serious and life-threatening infections and mean that iclaprim has a low propensity for the development of resistance.
Drug development is a difficult path filled with many failures, why do you believe Motif can be different?
The antibiotic has previously completed positive Phase III trials, but was turned down by the FDA in 2008, a time when antibiotics were not considered vital, after the developers became mixed up in a non-inferiority debate. So with positive data and a change in attitude towards antibiotics means that iclaprim has a very strong chance of approval. The FDA has agreed with Motif’s plan to run two new Phase III clinical trials each including 600 patents, to treat ABSSSI, comparing iclaprim to vancomycin. The trials are expected to take about 18 months to complete and have endpoints to satisfy both FDA and EMA requirements. Moreover, the trials will be run by Covance, a leading global CRO, which has unique insights into infectious disease clinical trials with over 17,000 patients in more than 150 studies. So, taking all this in to account we feel confident that iclaprim can be successful.
As a one product company is Motif over valued?
We believe that we are currently under-valued when compared to our peers listed on NASDAQ. In terms of iclaprim and its favourable risk profile, FDA has granted Qualified Infectious Disease Product (QIDP) designation to iclaprim, the first and only DHFRi to receive this designation. This means that iclaprim is now eligible for 10 years of market exclusivity, starting from the date of FDA approval. Analyst estimates for the global antibiotic market in 2020 is over $40 billion and iclaprim is a late stage product with proven clinical benefit in Phase III trials. With further Phase III trials results due in 2017 we are relatively close to regulatory filings and commercial launches if approved. Furthermore, it is in our stated aims to bring in other interesting programs to build up our pipeline.
Motif has achieved important milestones in months since it´s IPO, what is the next milestone for the Company?
Our next major milestone event will be the announcement of the first patient to be treated in the Phase III clinical trials to treat acute bacterial skin and skin structure infections (ABSSSI) and later a trial in hospital acquired bacterial pneumonia (HABP).