Update on Lupuzor™ Pivotal Phase III Study21st September 2017 - 3:04 pm
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.
- Study summary as at 15th September 2017
• 200 patients successfully recruited and randomised (dosed)
– all patients in the study have passed the 6 months stage
– 52 patients (26%) have completed 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 pleased to provide a further update of our pivotal Phase III study of Lupuzor™ in Lupus. All patients in the study have now passed the six months stage, with 52 patients (26%) having completed the full 12 months. We will now see an accelerated number of patients completing the full 12 months of the trial over the next couple of months. Importantly, with Lupuzor™ being administered to greater numbers of patients over a longer period of time, we are delighted to be observing the continuation of our robust safety profile.
With an urgent need for a new treatment for Lupus which is safe and effective, we are observing an ever increasing focus from the market, the scientific community and patient groups on Lupuzor™ as we get closer to completing this pivotal Phase III study. We are looking forward with confidence to the outcome of the trial and to reporting, on track, the top line results in Q1 2018.”
For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor