Novartis, Amgen and Banner Alzheimer's Institute have decided to halt the clinical programme with BACE1 inhibitor CNP520 (umibecestat) for the prevention of Alzheimer's disease.
The partnership will discontinue the evaluation of CNP520 in two pivotal phase II/III studies in the Alzheimer’s Prevention Initiative Generation Programme.
According to Novartis, an evaluation of unblinded data during a regular pre-planned review identified worsening in some measures of cognitive function and
Novartis chief medical officer and global drug development head Dr John Tsai said: “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.
“We remain committed to advancing science in Alzheimer’s disease and continue to seek future solutions for people with neurodegenerative conditions.”
The CNP520 was being evaluated 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 sponsors of the study advised investigators to discontinue the clinical programme of CNP520 in Alzheimer’s prevention and stop providing an investigational treatment to the participants. The study sponsors plan to further evaluate and present the data at a future scientific venue.
In August 2015, Novartis announced a global collaboration with Amgen for the development and commercialisation of novel treatments in the field of migraine and Alzheimer’s disease.
Novartis and Amgen, in collaboration with Banner Alzheimer’s Institute, sponsored the studies of Generation Programme.
Novartis is the regulatory sponsor, while Amgen and Novartis are co-development partners for the programme.
Amgen research and development executive vice president Dr David Reese said: “We still believe amyloid plays an important but complex role in Alzheimer’s disease.
“Although the outcomes of the research program 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.”