ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, has given DirectorsTalk further details of patient participation following confirmation (as announced on 22 December 2016) that the Company had successfully completed, on target, patient recruitment into its pivotal 52-week Phase III clinical trial of Lupuzor(TM), its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.
Study Summary
-- 200 patients successfully recruited and randomised (dosed)
o 293 patients initially screened illustrating the demand from physicians for a new safe and effective treatment for Lupus
-- 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients randomised
o Europe: 5 Countries and 16 sites with 81 patients randomised
o Mauritius: 1 site with 49 patients randomised
-- Study status as at the end of January 2017
o over 80% of patients will have been treated for at least 3 months
o 2 patients have completed the study
o 24 patients will have been treated for 9 months
o 50 patients will have been treated for 6 months
o 90 patients will have been treated for 3 months
— To date no drug (active or placebo) related ‘Serious Adverse Events’ have been reported. This is consistent with the strong safety profile of Lupuzor(TM) shown in its earlier Phase IIb study
-- Top line results are estimated to be reported in Q1 2018
Commenting on this trial, Tim McCarthy, Chairman of ImmuPharma said: “We are delighted to be able to now provide more details involved in the completion of recruitment of patients within our Lupuzor(TM) pivotal Phase III trial in Lupus.
Putting the data into context, 293 patients were initially screened in this study. We believe this illustrates the demand from physicians to meet the unmet medical need, for an effective and safe treatment for this debilitating and life threatening disease.
With the trial on track and two patients already safely completing their 12 month dosing regimen, we look forward to providing further updates on this pivotal Phase III trial as it progresses through 2017.”
Dr. Robert Zimmer, President & Chief Scientific Officer added: “Thanks to the diligent work performed by Dr. Fanny Valleix, Head of Clinical Research at ImmuPharma in conjunction with Simbec-Orion, our contract research partner, we achieved our goal to complete patient recruitment before the end of 2016.
Again it is important to note that no drug (active or placebo) related serious adverse events have been recorded to date which is consistent with the strong safety profile of Lupuzor(TM) shown in our earlier Phase IIb trial.”
