UK company ImmuPharma says that IPP-201101, its developmental drug for the treatment of the autoimmune disease lupus erythematosus (SLE), has met the primary endpoint of a Phase II trial.
The product is designed to modulate the immune response in lupus sufferers by modulating the activity of CD4+ T cells, which are involved in the pathogenesis of the disease.
ImmunPharma now says that it expects to file an Investigational New Drug application to start a Phase II/III trial programme with the US Food and Drug Administration in the first quarter of 2007.
In the study the drug, which was examined at 200mcg and 100mcg administered three times by subcutaneous injection, with a two-week interval between each treatment. Efficacy was determined using a measure of the quantity of self antibodies to double-stranded DNA that characterizes the disease.
The results of the assessment showed that the agent brought about a dose-dependant decrease in the level of self antibodies, with a maximum 47% reduction being achieved by some patients. In addition, 80% of the trial participants responded to treatment.