ImmuPharma Reports Positive Results For Lupuzor Trial

Published: 19-Nov-2009

Drug, well tolerated with adverse event rates lower

ImmuPharma has announced the final results from a Phase IIb trial of Lupuzor in active patients with Systemic Lupus Erythematosus (SLE). Lupuzor administered at 200mcg once-a-month for 3 months plus standard of care achieved improvement in patient response rate as measured by the combined score compared to placebo plus standard of care. The study results also show that Lupuzor was generally well tolerated, with adverse event rates lower with Lupuzor when compared to placebo.

The Phase IIb study was a randomised, double-blind placebo controlled, dose-ranging study in 150 patients designed to evaluate the efficacy of Lupuzor in a three-month treatment period of either subcutaneous (SC) injection of 200mcg once-a-month (4qw) or 200mcg twice-a-month (2qw) or placebo in addition to standard of care and followed by a 3 month follow-up period.

The primary efficacy endpoint of the study was based on the combined score, which is defined by: a reduction from baseline of at least 4 points on the 2K-sledai disease activity scale; no worsening of disease as measured by the Physician's Global Assessment; and no new BILAG A organ domain score and no more than one new BILAG B organ domain score. An additional end-point was the response rate based only on the decrease of the sledai score by 4 points.

An interim analysis was performed and included 125 patients out of the ITT population having completed by mid November 2008 the week 12 assessments, approximately half of them having also completed the 12 week follow-up period. These results were announced in January 2009 indicating that Lupuzor administered at a 200mcg dose once-a month for 3 months was statistically significantly superior to placebo, using a decrease of 4 points of the sledai score to define a responder with

drop-outs being considered according to the protocol as non-responders. As the study showed an improvement even with a much lower number of patients, ImmuPharma decided to stop the recruitment of further patients. All patients already recruited completed the study according to protocol.

All treatments (Lupuzor or placebo) were administered in addition of standard of care which may include patients on low dose steroids (less than 80mg prednisone/week). 200mg of Lupuzor administered once-a-month during 3 months (total 600mg) achieved a clinically and statistically meaningful improvement of the moderate to severe subgroup. An analysis after a further 12 week follow-up (with only standard of care) revealed that the responder rates further increased to reach about 70% in the moderate to severe subgroup compared to 59% on placebo. Lupuzor was well tolerated and its safety profile was better than placebo with less drop-outs (1 vs 8) and less serious AEs leading to discontinuation.

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