Anthera Pharma (ANTH) Says Pre-Specified Primary Endpoint Wasn't Met in Phase2b PEARL-SC Dose Ranging Study of Blisibimod
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Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) today announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.
The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).
In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI ≥10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks. In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44.
The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups. All doses of blisibimod demonstrated consistent serological response including reductions of B-cells, ds-DNA and improvements in both complement C3 and C4. Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events. A single suicide attempt and a non-fatal single tuberculosis infection were seen in the placebo group. There were seven deaths during the study - three in placebo and four blisibimod.
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The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).
In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI ≥10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks. In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44.
The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups. All doses of blisibimod demonstrated consistent serological response including reductions of B-cells, ds-DNA and improvements in both complement C3 and C4. Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events. A single suicide attempt and a non-fatal single tuberculosis infection were seen in the placebo group. There were seven deaths during the study - three in placebo and four blisibimod.
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