Clinical Review Leads to Discontinuation of Investigation into BACE Inhibitor for Alzheimer’s Prevention

July 17, 2019
Pharmaceutical Technology Editors

Novartis, Amgen, and Banner have announced their decision to discontinue the investigation into the BACE1 inhibitor CNP520 (umibecestat) as a preventative therapy for Alzheimer’s disease.

In a July 11, 2019 press release, Novartis, Amgen, and Banner have announced their decision to discontinue the investigation into the BACE1 inhibitor CNP520 (umibecestat) as a preventative therapy for Alzheimer’s disease.

The decision to discontinue the clinical program arose after a review of the clinical data from the Generation Program studies showed potential benefits of the treatment no longer outweighed the risks. In the assessment of the clinical data, worsening of some measures in cognitive function were identified.

“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 at Norvatis. “We remain committed to advancing science in Alzheimer's disease and continue to seek future solutions for people with neurodegenerative conditions.”

The study was assessing the safety and efficacy of CNP520 in the prevention or delay of the onset of Alzheimer’s disease in patients considered to be high risk, dependent on age and genetic status. Sponsors of the study are informing investigators about the discontinuation and are advising that participants stop taking the therapy with immediate effect. Follow-up appointments will be arranged with participants of the study by the clinical investigators.

Further assessment of the data that has been collected so far in the trial will be performed, and data sets are expected to be presented at future scientific events. “Beyond presenting our analyses, we will go a step further and will also share our data with the scientific community, not only to contribute to the increasing body of knowledge in Alzheimer's research but to add value to ongoing discussions with governments, multilateral organizations, patient groups, pharmaceutical companies, and society to ensure that we collectively address the public health challenges presented by this disease,” added Tsai.

Source: Novartis