Motif Bio Plc (LON:MTFB) Chief Executive Officer Dr Graham Lumsden caught up with DirectorsTalk for an exclusive interview to discuss the manufacturing of the Iclaprim clinical trial supplies
Q1: In your latest RNS, it stated that clinical trials supplies have now been manufactured, why is this manufacturing milestone so important for Motif?
A1: It’s important to Motif and we’re very proud of the team that we’ve been able to achieve this milestone because as pharmaceutical companies move from phase II to phase III, which is what Motif is indeed doing right now, you have to be able to prove that, in this case Iclaprim, our antibiotic, can actually be scaled up from pilot batches which are made in laboratories to commercial scale. In phase III, we’re actually 1,200 patients in our 2 skin trials and that means a relatively larger quantity of material and so, what we’ve been able to announce today is that we’ve demonstrated and proven that Iclaprim can be manufactured at the scale required to treat 1,200 patients. That’s really important because not all pharmaceuticals are able to be scaled up from pilot to commercial facilities and we’ve just demonstrated that and we think that’s a really important milestone for us.
Q2: Indeed, brilliant news. Does Motif now have enough Iclaprim to complete the 2 skin trials?
A2: Yes, very good question. We made the decision to manufacture enough for not just the 2 skin trials but also enough to do additional phase trails so for example, the hospital pneumonia trial we’re intending to do after we’ve got the 2 skin trials up and running. So yes, we have plenty of clinical trial supplies to do the 2 phase III skin trials and we have enough to do the hospital pneumonia trials as well.
Q3: It also stated that Motif Bio Plc have reprocessed the material, why is that?
A3: So, as part of the deal, at the beginning of this year 2015, whereby Motif acquired the worldwide exclusive development commercialisation rights for Iclaprim, we also acquired 600 kilos of what’s called API, active pharmaceutical ingredient, and this was manufactured about 8 years ago and what we’ve done is looked at the material, it’s been stored in steel drums under climate-controlled conditions since 2008, and we found that it’s in really really good shape, it’s 99.8% pure. However, we decided, and this is a good example of the calibre of the scientific team that we have at Motif, that it would be good to reprocess a quantity of this API to avoid any future questions from regulators such as FDA and EMA. So indeed what we’ve done is taken 100 kilos from the original 600 kilos, sent it back to the original manufacturer and asked them to reprocess it which basically means they repeat the very last step in the manufacturing process. So they take the API, which is a powder, they dissolve it in an alcohol solutions, it’s run through carbon filters then they recrystallize it so we have brand new API. That API is then taken to manufacture the sterile ampoules that we just announced today. So basically, we’re making sure that we’re not taking any chances, any shortcuts, we’re anticipating potential questions from regulators and making sure that there are no issues with these supplies moving forward.
