Alizyme
UK drug developer Alizyme's ulcerative colitis drug, Colal-Pred (prednisolone metasulfobenzoate), failed to meet efficacy targets in a Phase III study, sending the firm's shares down over 45% to 8.25 pence on the day of the news, July 24. Efficacy responder rate in the Colal-Pred arms (56%) was about 18% lower than that in the prednisolone cohort (74%) and so the drug's non-inferiority to the conventional steroid was not shown. However, Colal-Pred was statistically superior to prednisolone in the proportion of patients who were both responders in terms of efficacy and safety, thereby meeting the key secondary endpoint with respect to addressing the target product profile. Because the drug met its safety target, Alizyme noted that it has potential as a maintenance treatment for remission of UC. Only last month (Marketletter July 7), the UK firm licensed Colal-Pred to Netherlands-based Norgine BV in a deal that could earn it upfront and milestone payments of up to 42.7 million euros ($67.4 million) plus sales royalties.
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