ImmuPharma's shares dropped 19 percent following the announcement that a Phase II study of the potential lupus treatment Lupuzor did not reach statistical significance. But CEO Dimitri Dimitriou claims that the market has misinterpreted the study results, and that the subset of patients ImmuPharma intended to test did respond to the drug.
Lupuzor met its primary endpoint, but not statistical significance in the overall trial. "We modified the criteria for entry for the patients... but some of the centres kept on recruiting patients and actually these patients should not be part of the real measurement," Dimitriou said in a Reuters interview. In 62 percent of patients with moderate-to-severe lupus--the group ImmuPharma intended to test--Lupuzor did achieve statistical significance.
A year ago Cephalon licensed Lupuzor in a deal that could be worth up to $500 million if the drug reaches the market. Partners Human Genome Sciences/GSK and Immunomedics/UCB are also working on developing lupus drugs; no new therapy has been approved to treat the disease in the last 50 years.
- see ImmuPharma's release
- here's the Reuters report
- read the Dow Jones write-up