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news.0.5mg/kg and 1mg/kg doses in these trials to continue as planned
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Elan, a neuroscience-based biotechnology company, and Wyeth have announced that the companies will discontinue the highest of three dosing regimens, 2mg/kg, in the two ongoing Phase III studies of bapineuzumab in patients with mild to moderate Alzheimer’s disease who do not carry the apolipoprotein E4 allele.
Apolipoprotein E4 (ApoE4) is a known genetic risk factor for development of Alzheimer’s disease (AD). The 0.5mg/kg and 1mg/kg doses in these two trials will continue as planned, the two companies said.
This decision has no impact on two other ongoing studies, which are testing a single 0.5mg/kg dose of bapineuzumab in patients who carry the ApoE4 allele. No changes are planned for these two carrier studies. The Phase III program for bapineuzumab is reported to be the largest clinical program ever initiated in Alzheimer’s disease. It is expected that approximately 4,000 patients will be included across all four studies.
The decision of the companies to discontinue the 2mg/kg dose was made in concurrence with the study’s independent Safety Monitoring Committee (SMC), following its review of vasogenic edema (VE) in the ongoing Phase III clinical program. The SMC has also reviewed unblinded data regarding VE from the 0.5mg/kg and 1mg/kg dose cohorts in the non-carrier studies and does not have concerns about these cohorts at this time.
Moving forward, newly enrolled patients will be randomized to either the 0.5mg/kg or the 1mg/kg dose cohorts or to placebo. In consultation with the SMC, the companies plan to amend the protocols to allow patients who are currently receiving the 2mg/kg dose to be reassigned to the 1mg/kg dose.
Carlos Paya, president of Elan, said: Our review of the safety data and the feedback from the SMC made it clear that continued development of the highest dose was not advisable. 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.