Amgen and Novartis have announced the discontinuation of two pivotal Phase II/III clinical trials conducted in alliance with Banner Alzheimer's Institute to assess BACE1 inhibitor CNP520 for the prevention of the neurodegenerative disease.
The studies formed part of the Alzheimer's Prevention Initiative Generation Program and were designed to evaluate the safety and efficacy of CNP520 in preventing or delaying the onset of Alzheimer's.
Subjects at high-risk for symptoms depending on their age and genetic status were enrolled in the studies.
The decision to end the trials comes after a pre-planned analysis of unblinded data revealed worsening in certain cognitive function measures. Based on this, the partners said that the potential benefit of the study drug did not outweigh the risk.
Novartis Global Drug Development head and chief medical officer John Tsai said: “As researchers, we have to accept today's disappointing news as part of the search for innovative new treatments.
“We remain committed to advancing science in Alzheimer's disease and continue to seek future solutions for people with neurodegenerative conditions.”
Investigators are being informed of the decision to discontinue the programme and participants are being advised to stop taking the investigational drug.
AmgenResearch and Development executive vice-president David Reese said: “We still believe amyloid plays an important but complex role in Alzheimer's disease.
“Although the outcomes of the research programme did not lead to the results we aimed for, we are committed to sharing our findings to help advance the medical and scientific community one step further toward finding a prevention for this devastating disease.”
Amgen and Novartis partnered in 2015 for the development and commercialisation of therapies for migraine and Alzheimer's.
Novartis is the studies’ sponsor and development partner to Amgen. The trials were sponsored in alliance with Banner Alzheimer's Institute.
In March, Biogen and Eisai announced the suspension of two Phase III trials of aducanumab to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia.