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ImmuPharma completes phase III Lupuzor study; on track to publish top-line data this quarter

The last of the 200 patients has had their final assessment and the data is now being processed and analysed
lupus poster
Lupus is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood

ImmuPharma PLC (LON:IMM) has completed the pivotal phase III study of its Lupuzor lupus treatment, leaving it on track to publish top-line data from the trial in the current quarter.

The last of the 200 patients has attended their final assessment and data from the trial is now being collected, checked and analysed.

READ: ImmuPharma says last patient dosed in Phase III clinical trial of lupus treatment, Lupuzor™

AIM-quoted ImmuPharma said Lupuzor demonstrated a “robust safety profile” during the 12 month long trial, in keeping with what was seen in the successful phase IIb study.

The phase III trial was what’s called a randomised, double-blind investigation, which means half the group were given the ImmuPharma drug, while the others will have received a placebo that has no impact on the condition.

Even the doctors will only have found out which group is which when the study finished.

ImmuPharma 'delighted' with study completion

“We are delighted to announce this major milestone for ImmuPharma in having completed on track this pivotal Phase III trial for Lupuzor,” said chief scientific officer Robert Zimmer.

“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.”

Following requests from both investigators and patients, ImuuPharma is also kicking off a ‘follow-up’ study which will allow eligible patients to continue to receive Lupuzor for another six months.

WATCH: Immupharma 'looking forward and planning for success' with Lupuzor

The results will be gathered as an ‘extension’ open label study – i.e. patients will know that they’re taking the drug – and will be independent of the original late-stage trial.

Debilitating disease

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

According to the Lupus Foundation of America, around 1.5mln in the States have the condition, with 90% of those estimateed to be women.

Successful trial data will lead to ‘significant rerate’

Despite that rise, house broker Northland Capital reckons they’re probably worth 181p and likely significantly more if the data comes back positive.

“With the trial now complete and all patients successfully monitored, Lupuzor continues to demonstrate a strong safety profile,” said Northland analyst Vadim Alexandre.

“Should Lupuzor successfully meet the trial endpoints, we estimate that ImmuPharma’s shares would significantly rerate to the upside.”

Alexandre added: “Finally, it is encouraging to see demand from patients for a follow-up study.”

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