ImmuPharma PLC (LON:IMM) confirmed it is on track to publish top-line results from its phase III clinical trial in the first quarter of next year after it said over half the group had completed the full 12-month study assessing the performance of its potentially breakthrough treatment for lupus.
In all,116 of the 200 patients with the life-threatening auto-immune disease have been through the 52-week process looking at the efficacy of Lupuzor; all are now at or past the nine-month stage.
The phase III trial is what’s called a randomised, double-blind investigation, which means half the group will have been administered the ImmuPharma drug, while the others will have received a placebo that has no impact on the condition.
The doctors running the study will only know which group is which once the whole process is concluded.
At this stage they do know Lupuzor’s “robust” safety record remains consistent with what was seen at the successful phase IIb stage.
"The trial continues to progress on track and on time,” said chairman Tim McCarthy.
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.
The shares, up 84% in the year to date, marked time at 95p. City broker Northland reckons the stock is worth 185p.
“Should Lupuzor successfully meet the trial endpoints, we estimate that ImmuPharma’s shares would significantly rerate to the upside,” said analyst Vadim Alexandre.
It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.
ImmuPharma does not claim Lupuzor is a cure but hopes it will offer significant relief to sufferers such that their quality of life is greatly improved.
It also thought to be more effective than other products available, such as Glaxo's Benlysta.