ImmuPharma PLC (LON:IMM) Thursday confirmed it has completed patient recruitment for its phase III clinical trial of Lupuzor, a potentially breakthrough treatment for lupus.
It has delivered on its plan to have 200 sufferers of the life-threatening auto-immune disease taking part in the study by the end of the year.
Chairman Tim McCarthy said ImmuPharma had passed a “major milestone” and added that the company would update on progress throughout the year. In a previous update it said it expected to deliver “top-line results” at some point in 2017.
In regulatory terms, Lupuzor is in a strong position, already having received fast-track status from the all-powerful US Food & Drug Administration (FDA), which speeds up the approval process by shortening review periods.
ImmuPharma has also received regulatory approval to complete its trials under what’s known as a special protocol assessment.
This effectively guarantees the FDA will accept the trial results if they meet or exceed certain criteria.
Systemic Lupus Erythematosus (SLE), the most severe form of the disease, which Lupuzor is targeting, is debilitating and painful.
It sees the body's immune system turn against itself for reasons still not fully understood.
Symptoms include headaches, abdominal pain, chest pain, depression, psychosis and in some cases death.
It can affect various organs, including the heart and liver and is much more common in women, appears most often in African-Americans, Asians and Hispanics. It is estimated 5mln people globally have it.
Only one treatment - Glaxo's Benlysta - has been approved over the last 50 years. And, according to analysts, the product has proven a disappointment, in that it is only marginally effective while having side-effects.
Yet it still generates sales of around US$400mln, a figure that is predicted to grow to US$1bn by 2020.