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Update on Lupuzor™ Pivotal Phase III Study
Wednesday, May 17, 2017 - 10:45
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to provide an update of its pivotal 52-week, randomised, double-blinded, Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.
- 200 patients successfully recruited and randomised (dosed)
- 7 Countries and 28 sites are participating in the study
- US: 11 sites with 70 patients
- Europe: 5 Countries and 16 sites with 81 patients
- Mauritius: 1 site with 49 patients
- Study status as at end-April 2017
- all 200 patients have passed the 3 months stage
- over 80% of patients (166) have passed 6 months
- 49 patients have passed the 9 months stage
- 28 patients have passed the full 12 months of the study
- Continued robust safety record which remains consistent with Lupuzor™’s product profile as shown in its previous Phase IIb study
- Top line results remain on track to be reported in Q1 2018
Commenting on the trial update, Tim McCarthy, Chairman of ImmuPharma said: “We are delighted to provide a further update of our pivotal Phase III study of Lupuzor™ in Lupus.
Putting this data into context, key milestones have been achieved with all 200 patients passing the three months stage whilst 28 patients have now passed the full 12 months of the study. We are now in important new territory with over 80% of patients having had exposure to Lupuzor™ for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile.
With the study on track to report top line results in Q1 2018, we look forward to providing shareholders with further updates on this pivotal Phase III study as it progresses through 2017.”
For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor