Elan and Wyeth have decided to discontinue the highest of three dosing regimens in the two ongoing phase 3 studies of bapineuzumab in patients with mild to moderate Alzheimer’s disease, Elan said in a statement today.
Irish drugmaker Elan and its US partner Wyeth have decided to stop testing the highest dose of their experimental Alzheimer's drug bapineuzumab in final-stage Phase III studies.
The decision to discontinue the 2mg dose followed a review of cases of vasogenic edema, or fluid build-up in the brain.
“Our review of the safety data and the feedback from the Safety Monitoring Committee made it clear that continued development of the highest dose was not advisable,” Elan president Carlos Paya, said in a statement.
"The decision to remove the highest dose from development reduces risk to patients and it also helps to reduce risk to the overall development effort.”
Testing of the 0.5mg and 1mg doses in two Phase III trials will continue as planned. It is expected that approximately 4,000 patients will be included in the trials.
In a phase II trial of bapineuzumab, higher levels of vasogenic edema was observed in patients who were carriers of the ApoE4 allele, a genetic risk factor for alzheimer's and was more likely to occur at higher doses of bapineuzumab.
In the phase III trial the higher dosage was only given to non-ApoE4 allele carriers.
A spokeswoman said that for the small number of patients with vasogenic edema the effects were “mostly transient”.
Shares in Elan were flat at €5.03 in Dublin where the Iseq was up over 3 per cent.