Motif Bio plc
Motif Bio plc (LSE: MTFB, NASDAQ: MTFB) is developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria.
In August 2018, the U.S. Food & Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This means that the FDA has determined that the application is sufficiently complete to perform a substantive review. The NDA has been granted Priority Review, and the FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) of February 13, 2019.
The NDA includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI. In both trials, iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
In September 2017, iclaprim received Qualified Infectious Disease Product (QIDP) designation from the FDA. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).
Management
Graham Lumsden- Chief Executive Officer
Jonathan E. Gold- InterimChief Financial Officer
David Huang M.D., Ph.D., JD- Chief Medical Officer
Board of Directors
Richard C.E. Morgan- (Chairman) Chief Executive Officer, Amphion Innovations
Dr. Craig Albanese- Chief Operating Officer, New York Presbyterian/ Morgan Stanley Children's Hospital
Zaki Hosny- (Deputy Chairman)
Charlotta Ginman
- Financial and operational professional. Held senior roles at JP Morgan, Deutsche Bank and UBS.
Jon Gold - Senior Financial Analyst, Federated Investments
Graham Lumsden- Executive Director
Dr. Mary Lake Polan - Board of Directors, Wyeth Corporation, formally Professor and Chair emeritus, Department of Obstetrics and Gynecology, Stanford University School of Medicine
Bruce Williams - Biotechnology Industry Consultant, formally held senior marketing positions at Celgene Corp., and Ortho Biotech, a Johnson & Johnson company
