Completion of Lupuzor™ Pivotal Phase III Study and Initiation of Follow Up Study18th January 2018 - 10:49 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to confirm that the ongoing 52-week, randomised, double-blinded, Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, is now complete, following the last patient having attended their final assessment.
Final patient data from the trial are being collated and entered into the database, checked and analysed. This process is ongoing and top line results remain on track to be reported by the end of Q1 2018.
At completion, we continue to observe a robust safety profile over the 12 month period of patients’ participation in the trial.
Separately, following requests from both Investigators and patients involved in the Phase III study, ImmuPharma is initiating a “follow-up” study permitting eligible patients from the completed Phase III study, to receive Lupuzor™ (plus “Standard of Care”) for a further six months in an open-label scheme. The results will be gathered as an “extension” open label study, independent of the pivotal Phase III trial which is now completed.
Commenting on the trial update, Robert Zimmer (MD, PhD), President & CSO said: “We are delighted to announce this major milestone for ImmuPharma in having completed on track this pivotal Phase III trial for Lupuzor™.
“I would like to take this opportunity of thanking all of our Clinical Investigators; Simbec-Orion, our clinical research organisation and the ImmuPharma France team led by Dr Fanny Valleix, Head of Clinical Research. All were paramount in the execution and completion of this trial.
“With the continued robust safety achieved over this trial, we look forward with continued confidence to reporting top line results of the study this Q1 2018.”
For more information on the trial please visit: https://clinicaltrials.gov/ct2/show/NCT02504645
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.