ImmuPharma PLC (LSE:IMM) the specialist discovery and development pharmaceutical company is pleased to announce today the final results from a Phase IIb trial of LUPUZOR™ in active patients with Systemic Lupus Erythematosus (SLE). Lupuzor™ administered at 200 mcg once-a-month for 3 months plus standard of care achieved a clinically significant 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.
Highlights
- Lupuzor™ achieved a clinically significant improvement in patient response rate versus placebo in the intention to treat (ITT) analysis
- The improvement was statistically significant in a subgroup (90% of the ITT population) of moderate to severe patients
- 62% of this sub-group of patients were responders according to both a composite clinical score and a decrease of 4 points of the SLEDAI score when treated with Lupuzor™ 200 µg every 4 weeks for 12 weeks compared to 41% on placebo
- Lupuzor™ was generally well tolerated with fewer serious AEs leading to discontinuation
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