The positive results from the Phase III study means a submission to the NDA is imminent.
Companies: Motif Bio Plc
Motif Bio (LON: MTFB) has announced today the results from the Phase III clinical trial for its iclaprim product, which is being developed to treat acute bacterial skin and skin structure infections (ABSSSI).
The "positive top line" results of the REVIVE-2 study means the Group can file a New Drug Application (NDA), which, if approved, it is anticipated that iclaprim will be eligible to receive 10 years of market exclusivity in the U.S. from the date of approval.
Principal Investigator of the study, Ralph Corey MD, detailed the need for a drug like iclaprim...
"ABSSSI is a serious infection for which patients are frequently hospitalized for several days. Many of these patients have co-morbidities, such as renal impairment and diabetes. For these patients in particular, there is an urgent need for better treatment options. With the strong efficacy and safety results from REVIVE-2, including no renal toxicity, as well as fixed dosing, iclaprim, if approved, could be an important new treatment option for these patients."
This morning announcement has sent shares soaring, with the price at the time of writing up 28% on yesterday's closing price.
finnCap mentioned the announcement in its Morning Note today, saying:
"We retain our 100p price target and Buy recommendation pending FDA formal approval in 2018."
Before today's share price hike, Motif Bio had a market cap of £97m. As a clinical-stage biopharmaceutical company, the Group is yet to generate any revenue or profit, but today's news is sure to bring about a partnering or license deal to commercialise the product and bring it to market.