Update on Phase 3 trial data and Final Results
- ImmuPharma announced further data analysis on its Phase 3 trial data, as well as its final results for FY2017.
- ImmuPharma previously announced (17th April 2018) that across the entire trial population, patients who had anti-dsDNA autoantibodies (‘antibody positive’), Lupuzor™ demonstrated a superior, yet non-significant, response rate over placebo (61.5% vs 47.3%, p=0.0967). Anti-dsDNA autoantibodies are a recognised biomarker for Lupus.
- Today the Company announced further data analysis regarding the effect of Lupuzor™ on antibody positive patients. Within the European cohort (consisting of 130 patients across Europe and Mauritius) there were 79 patients (60.8%) who were antibody positive. Within the antibody positive group, those tested with Lupuzor™ plus standard of care (SoC) had a statistically significant reduction in disease activity compared to the placebo plus SoC group (71.1% vs 48.8%, p=0.0218).
- In the US cohort (72 patients) there were 28 patients who were antibody positive. However, the placebo plus SoC group showed greater disease reduction (6 patient responders) to Lupuzor plus SoC (5 patient responders) (35.7% vs 42.8%). This may require further analysis to explain the different result compared to the European cohort, but it is important to note this was a small sample size.
- These findings are a positive for the Company and the potential commercial value of Lupuzor™. The anti-dsDNA autoantibody is a significant biomarker within the lupus population and indicates a potential target population for Lupuzor™. The Company intends to continue to analyse the trial data and consult with its scientific and regulatory experts to discuss next steps. Meanwhile the company is continuing a Lupuzor™ extension study with 44 patients currently recruited and results expected in 2019. This is expected to provide further data on the safety and efficacy of Lupuzor™.
- Immupharma’s final year results were in-line with expectations. The Company had a cash position at year-end of £2.7m, which was augmented by a placing of £10m in January 2018. Loss for the period was £6.2m (31 December 2016: £5.3m).
ImmuPharma plc is a late clinical stage drug development business specialising in the area of autoimmune disease.