Motif Bio PLC’s (NASDAQ:MTFB, LON:MTFB) iclaprim next-generation antibiotic has moved a step closer to potential commercialisation after the last patient finished their treatment in the REVIVE-2 Phase III trial.
The study is investigating the safety and efficacy of iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
It followed the same protocol as REVIVE-1, which took place at a different centre and yielded positive top-line results earlier this year.
As with REVIVE-1, Motif Bio is hoping to prove that iclaprim scores well against the current gold standard treatment, vancomycin, in this second trial.
Results from the latest study are due in the fourth quarter of this year. Should those results also prove successful, the data from both trials is expected to satisfy the European and US regulatory authorities, Motif said.
On track to submit an NDA in 2018
Submission of a new drug application (NDA) for iclaprim as a treatment of ABSSSI is anticipated within the first half of 2018.
“The last patient treated in our REVIVE-2 trial is another key milestone for the company that keeps us on track to be able to submit an NDA next year,” said chief executive Graham Lumsden.
“We believe that iclaprim, if approved, could be an important option for hospitalised patients with ABSSSI, especially for those patients who also have kidney disease with or without diabetes.
“Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in renally impaired patients.”
‘Positive results will lead to significant re-rate’
“The achievement of this clinical milestone known as last patient out (LPO) follows on from a successful US$25.8m fundraise achieved earlier in the year and brings iclaprim a step closer to potential commercialisation,” said finnCap analyst Alex Pye.
“We continue to expect top-line readout within two or three months, with clinical results for REVIVE-2 possibly being available as early as mid-October.”
Pye added: “We retain our 100p target price and ‘buy’ recommendation as of this morning, expecting positive results to significantly re-rate the shares.”
Shares added 3% in early deals to trade at 29.9p.
--Updates for broker comment and share price--