ImmuPharma trial of Lupuzor continuing smoothly

Specialist drug discovery and development company ImmuPharma provided further details of patient participation on Wednesday, following confirmation in December that the company had successfully completed patient recruitment into its pivotal 52-week Phase III clinical trial of Lupuzor.

The AIM-traded firm said Lupuzor is its lead programme for the potential breakthrough compound for Lupus, the life threatening autoimmune disease.

It said the study had 200 patients successfully recruited and randomised, with 293 patients initially screened - which it said illustrated the demand from physicians for a new safe and effective treatment for Lupus.

A total of seven countries and 28 sites are participating in the study - 11 sites with 70 patients randomised in the United States, five Countries and 16 sites with 81 patients randomised in Europe, and one site with 49 patients randomised in Mauritius.

ImmuPharma said as at the end of January, over 80% of patients will have been treated for at least three months.

So far, two patients have completed the study, 24 patients will have been treated for nine months, 50 patients will have been treated for six months, and 90 patients will have been treated for three months.

It said to date no drug-related - active or placebo- 'serious adverse events' have been reported, which is reportedly consistent with the strong safety profile of Lupuzor shown in its earlier Phase IIb study.

The company said top line results are estimated to be reported in Q1 2018.

“We are delighted to be able to now provide more details involved in the completion of recruitment of patients within our Lupuzor pivotal Phase III trial in Lupus,” said ImmuPharma chairman Tim McCarthy.

“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.”

McCarthy said with the trial on track and two patients already safely completing their 12 month dosing regimen, the board was looking forward to providing further updates on the trial as it progresses through 2017.

Dr Robert Zimmer, president and 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™ shown in our earlier Phase IIb trial.”