A recent Phase III study undertaken by drug discovery and development company ImmuPharma demonstrated a superior response rate from its lupus compound, Lupuzor, but, due to a high response rate in the placebo group, the group's superior response was unable to allow statistical significance to be reached and the trial's primary endpoint was not met.
Lupuzor demonstrated a superior response rate over the placebo of 52.5% to 44.6% in the primary analysis of the full analysis set of all 202 patients taking part in the study and also confirmed the “outstanding safety profile of Lupuzor”, with zero serious adverse events reported.
Separately, following requests from both investigators and patients involved in the Phase III study, ImmuPharma launched an additional study permitting all patients who participated in the trial, to receive Lupuzor for the next six months in an open-label scheme with results to be gathered as an “extension” open-label study, independent of the Phase III trial.
ImmuPharma chairman Tim McCarthy, said, “Lupuzor has demonstrated, in this study, a superior response rate over placebo and its exceptional safety, giving it, we believe, a compelling product profile.”
“Whilst we are disappointed at the high response in the placebo plus standard of care group that resulted in statistical significance not being reached between the two treatment groups, we believe Lupuzor has the potential to bring a much needed safe treatment to the millions of Lupus sufferers around the world,” he added.
As directors believe that there is a significant opportunity for the drug, given the treatment alternatives currently available, they will review the study's full dataset and said they will work with its regulatory advisers “to determine the optimal next steps”.
ImmuPharma said it was in talks with and sharing the results of the Phase III study with “a number of larger pharmaceutical companies” who represent “potential commercial partners” that had made expressions of interest in the Lupuzor programme.
As of 0840 BST, shares had nosedived 87.76% to 18.00p.