Northland Capital partners view: Motif is now an important step closer to bringing its flagship antibiotic iclaprim to market. Having commenced patient dosing in its pivotal Phase 3 trials, the group is on track to complete the programme in H2-17, allowing for the drug (if approved) to be launched in 2018 as planned. Since listing in April 2015, Motif has met an aggressive timetable to get to dosing patients with iclaprim. The group has: obtained regulatory approvals to commence Phase 3 trials; raised c. £25m to fund the trials; appointed Covance to conduct the trials; obtained QIDP 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. We are confident Motif will meet its goal of completing the trials by the end of 2017.
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n Motif 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). n 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. n The two trials will be run by Covance and are global, multicentre, randomised, double-blind, Phase 3 studies evaluating a total of 1,200 adult patients who are hospitalised with ABSSSIs. n 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. n The successful completion of these two pivotal Phase 3 trials would satisfy both FDA and EMA requirements for regulatory approval. n With the dosing of the first patient underway, both ABSSSI trials are expected to be completed in 2H17. |
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Source: Northland Capital Partners Limited.
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