iclaprimTreatment for Skin and Structure Infection
First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections
March 2, 2016 -- Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces 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).
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. 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. 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.
The successful completion of these two pivotal Phase 3 trials would satisfy both FDA and EMA requirements for regulatory approval. With the dosing of the first patient underway, both ABSSSI trials are expected to be completed in 2H17.
ABSSSI is a serious and life threatening infection caused by multi-drug resistant bacteria. The Phase 3 programme is designed to obtain marketing approval for an intravenous formulation of iclaprim for the treatment of ABSSSI.
Graham Lumsden, CEO of Motif Bio, stated: “This is an important milestone for Motif that keeps us on track to complete the trials in the second half 2017. Iclaprim has the potential to be a major addition to the armamentarium of antibiotics much needed for the treatment of serious and life-threatening infections caused by multi-drug resistant bacteria in hospitalised patients.”
About Motif Bio plc
Motif is a clinical-stage biopharmaceutical company, specialising in the development of novel antibiotics that are designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus). Two Phase III ABSSSI clinical trials are on track to be completed in 2H17 and if approved, iclaprim could be ready for commercialisation in 2018. The HABP trial is expected to start 2H16.
The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria.
Source: Motif Bio plc
Posted: March 2016
- Motif Bio Receives Complete Response Letter From The FDA - February 14, 2019
- Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections - August 14, 2018
- Motif Bio Submits NDA for Iclaprim - June 14, 2018
- FDA Grants Fast Track Designation for Iclaprim - September 3, 2015
- FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI - July 22, 2015
- FDA Issues Complete Response Letter for Iclaprim - January 20, 2009
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome - November 21, 2008
- Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 - October 14, 2008
- Arpida Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008
- Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008
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