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NEW YORK (Reuters Health) Dec 09 - Immunotherapy with the novel investigational agent spliceosomal peptide P140 (IPP-201101; Lupuzor) safely improves the clinical and biological status of patients with systemic lupus erythematosus (SLE), according to results of an early phase II clinical trial.
P140 is an analog of a nuclear protein epitope recognized by lupus CD4+ cells, the researchers explain in the December issue of Arthritis & Rheumatism.
In a murine model of lupus, peptide P140 appeared to "initiate a mechanism of so-called tolerance spreading and reorient, at least transiently, the deleterious autoimmune response," write Dr. Sylviane Muller at the Centre National de la Recherche Scientifique in Strasbourg, France, and colleagues.
The research team conducted an open-label, dose-escalation trial among 20 adult patients with moderately active SLE. P140 was administered in three subcutaneous injections at 2-week intervals. Ten patients were treated with doses of 200 g, and 10 with doses of 1000 g.
Treatment at the lower dose was associated with statistically significant reductions in anti-double-stranded DNA antibody titers -- 17% reduction at day 15 (p = 0.007) and a 24% reduction at day 43, (p = 0.0014).
A more limited reduction was observed with the higher dose, with a transient but statistically significant decrease on day 15 only (14.5% reduction, p = 0.0176), the investigators report.
Mean scores on the SLE Disease Activity Index decreased in a progressive and sustained manner in the 200-g dose group from 7.8 at baseline to 4.8 by day 43. A lesser response was observed in the 1000-g dose group.
Median plasma levels of C reactive protein decreased in both groups. Adverse effects were minimal, comprising local irritation at the injection site at the higher concentration.
"These data warrant the further evaluation of IPP-201101 in a placebo-controlled clinical study," Dr. Muller's team states. To that end, "a phase IIb clinical trial has recently been initiated including 120 patients from Latin America and Europe."
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