LONDON (Thomson Financial) - Alizyme Plc said its COLAL-PRED ulcerative
colitis drug missed a key efficacy goal during large-scale trials and it is
holding discussions with partners to work out the best way forward.
During the European phase III trial, the drug met its safety goal but missed
its key efficacy goal of showing non-inferiority to conventional prednisolone.
But the company said the drug met a key secondary goal because it was
statistically superior to prednisolone in the proportion of patients who were
both efficacy and safety responders.
Chief executive Tim McCarthy said in a statement: "We are pleased to report
that the headline results of this study indicate that COLAL-PRED is a safe
steroid in the treatment of ulcerative colitis. The headline results also
indicate that this product has potential for maintenance of remission of
ulcerative colitis.
"We will continue to analyse the results and, in conjunction with our
partners and regulatory advisors, establish the optimum way forward in
commercialising this product."
ben.deighton@thomsonreuters.com
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