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Novartis, Amgen Scrap Pivotal Study Of Alzheimer's Prevention Drug

Shanthi Rexaline

A drug to treat Alzheimer's disease is increasingly proving elusive, despite billions of dollars spent on research and development.

Johnson & Johnson (NYSE: JNJ)'s Janssen unit; Merck & Co., Inc. (NYSE: MRK); and Eli Lilly And Co (NYSE: LLY) in collaboration with AstraZeneca plc (NYSE: AZN) all scrapped their respective BACE inhibitor programs in 2018.

On Thursday, another pharma partnership threw in the towel. 

Novartis, Amgen Give Up

Novartis AG (NYSE: NVS), Amgen, Inc. (NASDAQ: AMGN) and the Banner Alzheimer's Institute announced Thursday after the market close their decision to discontinue the clinical trials of CNP520, a BACE1 inhibitor that was being evaluated for preventing Alzheimer's disease in two pivotal Phase 2/3 studies.

The decision follows an assessment of unblinded data during a regular pre-planned review that identified worsening in some measures of cognitive function.

The sponsors concluded that the "potential benefit for participants in the studies did not outweigh the risk."

The BACE Theory — And Why It's Failing 

Alzheimer's is a neurological disease that leads to an irreversible, progressive brain disorder that impairs memory and thinking skills. It is believed to be caused by the accumulation of clumps of a protein called amyloid beta as well as twisted strands of a protein called tau between the cells.

BACE inhibitors impede the activity of BACE — beta amyloid cleaving enzyme — which in turn reduces the production of amyloid beta and improves the functioning of nerve cells.

Several hypotheses have been put forward regarding the setbacks in developing BACE inhibitors. Chief among them are safety concerns due to the drug structure and the complete blocking of amyloid beta that affects regulation of new neurons formed, according to Eureka Alert.

Another plausible reason could be that since Alzheimer's disease is typically diagnosed late, BACE inhibitors are not able to effectively arrest the disease despite blocking amyloid beta.

What's Next

Novartis said it plans to further assess and present the data at a future scientific venue and also share the data with the scientific community.

The company reiterated its commitment to neuroscience and said it supports patients and physicians in many disease areas such as multiple sclerosis, migraine, spinal muscular dystrophy and specialty neurological conditions.

"Our neuroscience pipeline remains robust with four molecules currently in clinical development, as well as early assets in Alzheimer's," Novartis said in a statement. 

Novartis shares were down 1.65% at $88.88 at the time of publication Friday, while Amgen shares were down 1.6% at $175.15. 

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