During the course of its Phase IIb study an interim analysis was performed and reviewed by an independent data monitoring committee according to ICH guidelines. This analysis was conducted after 125 randomized patients had completed the 12-week treatment period, half of them having also completed the additional 12-week follow-up (week 24).
The primary efficacy measure was a ‘SLEDAI response’ defined as a decrease of at least four points in the SLEDAI score, a scale generally accepted by physicians as an assessment of the clinical activity of lupus patients, a lower score representing lower disease activity.
According to the company, the analysis of the data has demonstrated that the 200mcg dose of Lupuzor administered every four weeks was statistically significantly superior to placebo (p=0.015). Lupuzor was generally well-tolerated with no significant drug-related adverse events recorded.
Based on this interim analysis, ImmuPharma has discontinued the recruitment of more patients for the Phase IIb study. The 147 patients already randomized will continue the study to completion according to the protocol. A full analysis of the data will be provided in due course, the company said.
Robert Zimmer, president and chief scientific officer of ImmuPharma, said: We are absolutely delighted by these results. It is, according to our knowledge, the first drug showing significant superiority over placebo in the treatment of lupus patients with such an excellent safety profile. We are now actively progressing the preparatory phase of the Phase III program.