Novartis, Amgen and Banner Alzheimer’s Institute discontinued investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer’s Prevention Initiative Generation Program.
An assessment of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function. Given these findings, the sponsors concluded that the potential benefit for participants in the studies did not outweigh the risk.
“Novartis has a strong research focus and commitment to patients. As researchers we have to accept today’s disappointing news as part of the search for innovative new treatments,” said John Tsai, Head of Global Drug Development and Chief Medical Officer. “We remain committed to advancing science in Alzheimer’s disease and continue to seek future solutions for people with neurodegenerative conditions.”
CNP520 was being assessed for safety and efficacy in the prevention or delay of the onset of Alzheimer’s in people at high risk for developing symptoms based on their age and genetic status. The study sponsors are informing investigators of the decision to discontinue the clinical program of CNP520 in Alzheimer’s prevention, and advising that participants should stop taking the investigational treatment. The clinical investigators will contact participants to discuss what happens next, including follow-up appointments as appropriate.
“Like our trial partners, we too are profoundly disappointed about the news of the need to discontinue the BACE 1 Inhibitor CNP520 arm of the Alzheimer’s Prevention Initiative (API) Generation Study 1,” said Richard J. Hodes, Director of the National Institute on Aging, NIH. “We understand that this will be disheartening to the study participants and investigators; however, the safety of participants is the primary concern leading to this decision. We are grateful to the participants and their study partners for their time and valuable contributions to this research.