Shares in ImmuPharma plunged as much as 85 percent after the company disclosed that a Phase III study of Lupuzor for the treatment of lupus failed to meet its primary endpoint. Despite the results, ImmuPharma suggested that the data provide evidence for further studies of Lupuzor, adding that it is in ongoing discussions with a number of larger pharmaceutical companies.
The trial randomised patients to receive standard of care either in combination with Lupuzor or placebo, with responses assessed based on the SLE Responder Index score. Results for all 202 patients in the study showed that while Lupuzor demonstrated a superior response rate over placebo of 52.5 percent versus 44.6 percent, the difference between the groups was not significant. ImmuPharma said that this was due to a "high response rate" in the placebo group.
According to the company, in the 153 patients who completed the study, Lupuzor was associated with a response rate of 68.8 percent compared to 59.2 percent for placebo. ImmuPharma added that in subjects who had anti-dsDNA autoantibodies, a biomarker for systemic lupus erythematosus, Lupuzor had a response rate of 61.5 percent versus 47.3 percent for placebo. The drugmaker noted that 7.6 percent of these patients in the Lupuzor group went into full remission versus none in the placebo group.
ImmuPharma indicated that it will review the study's full dataset to determine the next steps. The company added that it will also share the results with potential commercial partners.
Chief scientific officer Robert Zimmer remarked "the study demonstrated that Lupuzor had a superior response rate over placebo," adding "the results in the anti-dsDNA antibody positive group are also encouraging."
However, Panmure Gordon analyst Mike Mitchell said "our initial reaction is to assume Lupuzor is no longer a meaningful candidate for marketing authorisation for the treatment of lupus."
To read more Top Story articles, click here.