Motif Bio plc, the clinical stage biopharmaceutical company specialising in developing novel antibiotics, yesterday announced the dosing of the first patient in two Phase 3 clinical trials of its lead antibiotic candidate iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). The REVIVE (Randomized Evaluation IntraVenous Iclaprim Vancomycin TrEatment) clinical trials will assess the efficacy and safety of iclaprim compared to a standard of care antibiotic, vancomycin, for the treatment of ABSSSIs. The two trials will be run by Covance and are global, multicentre, randomised, double-blind, and Phase 3 studies evaluating a total of 1,200 adult patients who are hospitalised with ABSSSIs. The primary endpoint for the studies will be at least a 20 per cent reduction in lesion size at 48 to 72 hours after treatment. The key secondary endpoint is clinical cure at one to two weeks after treatment. The successful completion of these two pivotal Phase 3 trials would satisfy both FDA and EMA requirements for regulatory approval. With the dosing of the first patient underway, both ABSSSI trials are expected to be completed in 2H’2017. ABSSSI is a serious and life threatening infection caused by multi-drug resistant bacteria. The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim for the treatment of ABSSSI.
Beaufort Securities view: Another step closer. Delivering on its promises. Building value with every announcement. With both ABSSSI trials expected to be completed in 2H’2017, the planned 2018 commercial launch is becoming an increasingly real possibility. 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. Being a platform drug with a long pipeline of further indications, which could at least provide part of the solution to the medical world’s looming antibiotic crisis, suggests iclaprim is capable of creating quite considerable value. Having raised some US$25m funding, Motif’s management is pressing ahead with an accelerated dosing timetable, has appointed a leading CRO (Covance) to conduct the trials and won fast-track designation while also appointing a US financial advisor in anticipation of it achieving a NASDAQ quotation (possibly during Q3’2016). The latter point, of course, is key to Motif’s equity performance, given the premium valuation US healthcare investors typically award to such early stage developments. NASDAQ-quoted Paratek Pharmaceuticals which, for example, is highly comparable to Motif in terms of medical indication and development stage, enjoys a valuation almost four-times that of Motif. Motif Bio is one of Beaufort’s key picks for 2016 and we retain our Speculative Buy rating on the shares.
