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news.ImmuPharma said that additional analysis from its phase III trial of Lupuzor in patients with systemic Lupus erythematosus (SLE) has demonstrated positive results in the Europe cohort.
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Top line results from the study announced last month revealed the treatment missed its primary endpoint.
Howevr, additional data analysis showed that in the European cohort, Lupuzor had a statistically significant 71.1% response rate against a 48.8% rate in the control group, which received a dummy pill and the standard of care.
In the European group of 130 patients, 79 patients, or 60.8% of the group, were anti-dsDNA autoantibody positive.
In the US study group of 72 patients, 40% were antibody positive with an equal number of 14 patients in both the active and comparator groups.
ImmuPharma said scientific literature suggests that about 60% to 70% of patients diagnosed for Lupus are antibody positive.
The company noted that those proportions were seen in the Europe cohort, where 60.8% of patients were antibody positive, and could therefore be considered as representative of the overall Lupus population.
ImmuPharma chief scientific officer Robert Zimmer said the data showed that antibody positive patients in the Europe cohort responded significantly better when receiving Lupuzor, compared to those in the comparator group.
“Current treatments (monoclonal antibodies, steroids etc.,) prescribed to Lupus patients are essentially symptomatic treatments acting irrespectively of the antibody status of the patients.
“The potential efficacy of Lupuzor seems to be correlated with the presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and we hope to confirm that Lupuzor™ will come to be considered as a disease modifying agent.”
Lupuzor, also referred to as Forigerimod, or P140, is ImmuPharma's lead compound and a potential treatment for lupus, a potentially life-threatening auto-immune disease.
It intends to modulate the body's immune system so that it does not attack healthy cells, and prevents causing adverse side effects. Lupuzor has the potential to stop the progression of the disease in a substantial proportion of patients.
Image: Top line results from the study announced last month revealed the treatment missed its primary endpoint. Photo: courtesy of jk1991/FreeDigitalPhotos.net.
