Motif Bio plc (LON: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the last patient has finished the treatment phase in REVIVE-1, the Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
REVIVE-1 is a 600-patient double-blinded, global, multicentre trial, in patients with ABSSSI that compares the safety and efficacy of an 80mg intravenous dose of iclaprim with 15mg/kg intravenous vancomycin. Treatments were administered every 12 hours for 5 to 14 days. Data read-out is expected in the second quarter of 2017. Data read-out for REVIVE-2 is anticipated in the second half of 2017. Successful completion of the two REVIVE trials is expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI.
Commenting on this milestone, Graham Lumsden, CEO of Motif Bio plc, said: “Thanks to the patients and investigators who participated in REVIVE-1, we remain on track to be able to share the first data from our Phase 3 clinical trials in Q2 17. We believe that iclaprim, if approved, can be an important option for patients hospitalised with ABSSSI who also have kidney disease with or without diabetes. It is estimated that up to 26% of the 3.6 million ABSSSI patients hospitalised annually in the U.S. have kidney disease.”
Zeus Capital said:
Motif Bio, a late clinical stage antibiotic development company, has announced that the treatment phase has finished for the last patient in REVIVE-1, the first of two phase III clinical trials of iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI). With this news Motif Bio is firmly on-track to report headline results from the trial in Q2. We believe iclaprim remains a highly valuable new antibiotic and take the rapid enrolment of patients in this trial as an indicator of the strong clinical need for a product with its performance characteristics, particularly for patients with renal impairment (some 26% of the estimated 3.6m hospitalized ABSSSI patients in the USA annually). Our fair value estimate for Motif Bio stands at 107p.
- As a reminder, REVIVE 1 and 2 are the names given to two identical phase III clinical trials in ABSSSI in which the company is evaluating the performance of its antibiotic, iclaprim. These international, multicentre trials began in March 2016 and are being conducted by the CRO Covance. Each trial will treat 600 patients, randomised to receive either iclaprim or vancomycin (standard of care) intravenously every 12 hours for 5 to 14 days. Iclaprim has been designated by the FDA as a Qualified Infectious Disease Product (QIDP) for ABSSSI providing an additional 5 years of Hatch-Waxman market exclusivity post approval (giving a total of 10 years market exclusivity) and Fast Track designation for regulatory submissions and review. We continue to expect REVIVE -2 results in H2 2017.
- The completion of treatment phase for the last patient in REVIVE-1 is a significant milestone for the company. Treatments for patients in the trial continued for a minimum of 5 days up to a maximum of 14 days. Each patient is followed for a total of 28-32 days from the initiation of treatment. This time span includes the day 21-28 ‘Test-of-cure’ evaluation for the EMA primary endpoint and a final follow-up phone call. The FDA primary endpoint is the early response (day 2-3) reduction in lesion size of >20%.
Comment: If this last patient was treated for only 5 days there will be a further maximum of 27 days until the final follow-up phone call is completed, taking us to the end of February for the trial to be concluded. Several weeks are ordinarily required for further data processing including unblinding and statistical analysis but the company is confident of being able to report headline results in Q2. As REVIVE-2 is still ongoing, we expect only headline safety and efficacy results from REVIVE-1 will be reported (too much detail could potentially compromise the blinding of REVIVE-2). We remain confident of a positive outcome for the study based on prior efficacy and safety data obtained using iclaprim in earlier phase III trials.