Beta-Secretase (BACE) Inhibitors, a Novel Advancement for the Treatment of Alzheimer\’s Disease

According to a new research report “Beta-Secretase (BACE) Inhibitors Pipeline Analysis, 2017 – Clinical Trials & Results, Patent, Designation, Collaboration, and Other Developments” published by P&S Market Research, BACE inhibitors currently exhibit a pipeline with estimated 15 drug candidates.

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BACE inhibitors offer novel therapeutic approach for the treatment of Alzheimer’s disease

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.

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.

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Phase III, the highest stage of development for BACE inhibitors

There are three BACE inhibitor drug candidates in the Phase III stage of development. Lanabecestat is a Phase III stage drug candidate by AstraZeneca plc for the treatment of Alzheimer’s disease. It is a small molecule that inhibits BACE1/2. The drug candidate is administered by oral route. E2609 is under Phase III stage of development by Eisai Co., Ltd. for the treatment of AD. It is a small molecule that inhibits BACE. Eisai Co., Ltd. entered in a collaboration with Biogen Idec for the development and commercialization of E2609, for the treatment of Alzheimer’s disease. The agreement also provided Eisai with an option to jointly develop and commercialize two of Biogen Idec’s candidates for Alzheimer’s disease – the anti-amyloid beta (Aβ) antibody, BIIB037, and an anti-tau monoclonal antibody.

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.

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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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