The study analyzed that the Beta Secretase inhibitors pipeline comprised 15 drug candidates, of which three products are in Phase III, three products in Phase II, one product in Phase I, and one product is in Discovery. The development of two BACE inhibitor candidates was found to be inactive, and five products were discontinued. BACE is a cleaving enzyme of aspartyl protease with beta-secretase activity. It acts as a precursor of beta-amyloid (Aβ) protein. In Alzheimer’s disease, the Aβ protein fragments get accumulated in plaques in the brain. BACE initiates Aβ production by cleaving amyloid precursor protein (APP) to generate APPβ and C99, which is critical for the subsequent cleavage of C99 by gamma-secretase to release Aβ1-40 and Aβ1-42. Inhibition of BACE enzyme disrupts the production of toxic Aβ and formed plaque and new soluble oligomers.
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Insights on pipeline segments
As per the findings of the research, around 80% pipeline drug candidates of BACE inhibitors are being developed to be administered by oral route and 7% by intravenous route. Most of the therapeutic candidates are being developed to be administered by oral route due to high patient compliance.
Alzheimer’s disease drug development receives Fast Track designation
Among BACE inhibitors, AZD3293, a drug candidate of AstraZeneca plc and Eli Lilly and Company, received Fast Track designation by the U.S. Food and Drug Administration (FDA) in August 2016. The FDA’s Fast Track program was designed to expedite the development and review new therapies to treat serious conditions and tackle unmet medical needs.
Major companies collaborate for the development of BACE inhibitors
The research finds that different companies collaborated for the development of BACE inhibitors. In September 2015, Novartis entered in a global collaboration with Amgen to commercialize and develop BACE inhibitor program in Alzheimer’s disease. Novartis oral CNP520 will be the lead molecule and further compounds from both companies’ Pre-Clinical BACE inhibitor programs may be considered as follow-on molecules. The collaboration also focused on new Amgen drugs in the migraine field, including Phase III AMG 334 and Phase I AMG 301. For the migraine program, Novartis was expected to have global co-development rights and commercial rights outside the U.S., Canada and Japan.
Some of the key players developing BACE inhibitors are AstraZeneca plc, Eli Lilly & Company, Johnson & Johnson, Merck & Co., Inc., Novartis AG, Eisai & Co., Ltd., CoMentis, Inc., vTv Therapeutics, Inc., Pfizer Inc., F. Hoffmann-La Roche Ltd., and Boehringer Ingelheim GmbH.
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