Invion completes clinical trial of INV103 (ALA-CPN10) in lupus patients
Invion Limited has completed its Phase II clinical trial entitled “Double-blinded, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and biochemical activity of intravenous Cpn10 administration in subjects with SLE (NCT01838694)”.
The Company’s decision to complete the trial is based on the review of safety and biochemical markers of effect in 28 subjects across four cohorts, which show that the study has met its objectives and supports the continued development of INV103 (ala-Cpn10) in longer and larger trials in patients with autoimmune diseases.
Significant data were derived from extracting white blood cells from patients before and after certain doses and stimulating these cells (peripheral blood monocytic cells or PBMCs) to produce inflammatory signals. PBMCs are hypothesized to play a critical role in autoimmune diseases.
Subjects in the first cohort, who received 10mg intravenously twice-weekly for four weeks, showed no consistent effect on stimulated PBMC production of 3 key cytokines (IL-1Beta, IL-6 and TNF-alpha) measured at two time points.
In contrast, subjects in the second cohort (30mg intravenously twice-weekly for four weeks) showed a consistent decrease in production of all three cytokines measured at the same two time points in stimulated PBMC.
Data from the third cohort (100mg intravenously twice-weekly for four weeks) support findings from the second cohort, although, like the placebo data, had some variability.
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