Alzheon
{{Infobox company
| name = Alzheon
| logo = Alzheon_Logo.svg
| logo_size =
| type = Private
| slogan =
| foundation = 2013
| location = Framingham, Massachusetts, United States
| key_people = Martin Tolar, MD, PhD (CEO)
Neil Flanzraich (Executive Chairman of the Board of Directors)
| industry = Pharmaceutical
| products =
| owner =
| num_employees =
| parent =
| homepage = {{URL|http://www.alzheon.com}}|
}}
Alzheon is an American clinical-stage biopharmaceutical company based in Framingham, Massachusetts.{{Cite news|url=https://www.technologyreview.com/s/520721/startup-finds-hope-in-second-look-at-failed-alzheimers-drugs/|title=Startup Finds Hope in Second Look at "Failed" Alzheimer's Drugs|last=Young|first=Susan|date=Mar 10, 2016|work=MIT Technology Review|access-date=August 24, 2016}} The company is developing medicines for patients with Alzheimer's disease and other neurological and psychiatric disorders.{{cite web|last1=Lash|first1=Alex|title=Failed Alzheimer's Drug To Get Another Shot, If Investors Pony Up|url=http://www.xconomy.com/boston/2016/03/11/failed-alzheimers-drug-to-get-another-shot-if-investors-pony-up/|website=Xconomy|access-date=29 April 2017|date=11 March 2016}}
History
Alzheon was founded in July 2013 by Martin Tolar, MD, PhD, a veteran of Alzheimer's drug programs, who serves as president and CEO of the organization.{{Cite news|url=http://www.bizjournals.com/boston/blog/bioflash/2015/03/lexingtons-alzheon-gives-its-own-alzheimer-s-news.html|title=Lexington's Alzheon gives its own Alzheimer's news to rival Biogen's|last=Seiffert|first=Don|date=March 20, 2015|access-date=August 23, 2016|via=Boston Business Journal}} Alzheon completed a $10 million Series A round of financing in April 2015{{cite web|last1=Fidler|first1=Ben|title=Alzheon Gets $10M to Take Castoff Alzheimer's Drug Into Pivotal Test|url=http://www.xconomy.com/boston/2015/04/08/alzheon-gets-10m-to-take-castoff-alzheimers-drug-into-pivotal-test/#|website=Xconomy|access-date=29 April 2017|date=8 April 2015}}{{Cite web|url=https://blogs.wsj.com/venturecapital/2015/04/08/the-daily-startup-in-a-hot-market-freestyle-capital-raises-larger-fund/|title=In a Hot Market, Freestyle Capital Raises Larger Fund|last=Billings|first=Mike|date=April 8, 2015|publisher=The Wall Street Journal|access-date=August 25, 2016}} and started the Phase lb bridging clinical program for ALZ-801, which was completed in July 2016.{{cite web|title='Gene-dose' effect for Alzheon's ALZ-801, a drug targeting Alzheimer's|url=https://www.thepharmaletter.com/article/gene-dose-effect-for-alzheon-s-alz-801-a-drug-targeting-alzheimer-s-disease|website=The Pharma Letter|access-date=29 April 2017|language=en}}{{cite web|last1=Fernandes, PhD|first1=Joana|title=Early Alzheimer's Patients with Risk Gene Respond to ALZ-801 in Studies|url=https://alzheimersnewstoday.com/2017/03/31/alz-801-tramiprosate-alzheon-seen-to-treat-mild-alzheimers-patients-in-studies/|website=Alzheimer's News Today|access-date=29 April 2017|date=31 March 2017}}
In August 2018, Alzheon appointed former IVAX President Neil Flanzraich, JD, as Vice Chairman of Board of Directors.{{Cite news|url=https://www.bloomberg.com/press-releases/2018-08-06/alzheon-appoints-former-ivax-president-neil-flanzraich-jd-as-vice-chairman-of-board-of-directors|title=Alzheon Appoints Former IVAX President, Neil Flanzraich, JD, as Vice Chairman of Board of Directors|newspaper=Bloomberg.com|date=6 August 2018 |access-date=2020-04-09}}{{Cite web|url=https://www.businesswire.com/news/home/20180806005227/en/Alzheon-Appoints-IVAX-President-Neil-Flanzraich-JD|title=Alzheon Appoints Former IVAX President, Neil Flanzraich, JD, as Vice Chairman of Board of Directors|date=2018-08-06|website=www.businesswire.com|language=en|access-date=2020-04-09}}
In August 2020, Alzheon was awarded a $47 million grant over five years from the U.S. National Institute on Aging, part of the National Institutes of Health. The grant is to support the Phase 3 clinical trial of ALZ-801 that began in May 2021{{Cite web|title=Alzheon receives $47M NIH grant funding its phase III Alzheimer's study|url=https://www.bioworld.com/articles/496869-alzheon-receives-47m-nih-grant-funding-its-phase-iii-alzheimers-study?v=preview|access-date=2020-09-11|website=www.bioworld.com|language=en}}{{Cite news|last=Gormley|first=Brian|date=2020-08-20|title=Biotechs Tap Growing U.S. Government Support for Alzheimer's Research|language=en-US|work=Wall Street Journal|url=https://www.wsj.com/articles/biotechs-tap-growing-u-s-government-support-for-alzheimers-research-11597917600|access-date=2020-09-11|issn=0099-9660}}
Pipeline
Alzheon's leading candidate, valiltramiprosate (ALZ-801), is an oral prodrug of the active agent tramiprosate{{Cite journal |last1=Tolar |first1=Martin |last2=Abushakra |first2=Susan |last3=Hey |first3=John A. |last4=Porsteinsson |first4=Anton |last5=Sabbagh |first5=Marwan |date=2020-08-12 |title=Aducanumab, gantenerumab, BAN2401, and ALZ-801—the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval |journal=Alzheimer's Research & Therapy |volume=12 |issue=1 |pages=95 |doi=10.1186/s13195-020-00663-w |issn=1758-9193 |pmc=7424995 |pmid=32787971 |doi-access=free }} that targets neurotoxic soluble amyloid oligomers,{{Cite journal|last1=Hey|first1=John A.|last2=Kocis|first2=Petr|last3=Hort|first3=Jakub|last4=Abushakra|first4=Susan|last5=Power|first5=Aidan|last6=Vyhnálek|first6=Martin|last7=Yu|first7=Jeremy Y.|last8=Tolar|first8=Martin|date=2018-09-01|title=Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain|url= |journal=CNS Drugs|language=en|volume=32|issue=9|pages=849–861|doi=10.1007/s40263-018-0554-0|issn=1179-1934|pmc=6153967|pmid=30076539}}{{Cite web |title=Alzheon Reports Industry-Leading Disease Modifying Effects from Phase 2 Biomarker Trial of Oral Tablet ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer's Disease |url=https://www.biospace.com/article/alzheon-reports-industry-leading-disease-modifying-effects-from-phase-2-biomarker-trial-of-oral-tablet-alz-801-valiltramiprosate-in-patients-with-early-alzheimer-s-disease/ |access-date=2022-04-05 |website=BioSpace |language=en-US}}{{Cite journal |last1=Tolar |first1=Martin |last2=Abushakra |first2=Susan |last3=Sabbagh |first3=Marwan |date=January 2020 |title=The path forward in Alzheimer's disease therapeutics: Reevaluating the amyloid cascade hypothesis |journal=Alzheimer's & Dementia |language=en |volume=16 |issue=11 |pages=1553–1560 |doi=10.1016/j.jalz.2019.09.075 |pmid=31706733 |s2cid=207844779 |issn=1552-5260|doi-access=free }} and received Fast Track designation from the FDA in 2017.
ALZ-801 oral tablet is being evaluated in Phase 2 biomarker study in early Alzheimer's disease patients with homozygous and heterozygous APOE4 genotype.
ALZ-801 is also in Phase 3 clinical development for high-risk homozygous APOE4/4 patients with early Alzheimer's Disease. Patients with two alleles of APOE4 have up to 20 times the risk of developing Alzheimer's disease.{{Cite journal|last1=Hauser|first1=Paul S.|last2=Ryan|first2=Robert O.|date=October 2013|title=Impact of Apolipoprotein E on Alzheimer's Disease|journal=Current Alzheimer Research|volume=10|issue=8|pages=809–817|doi=10.2174/15672050113109990156|issn=1567-2050|pmc=3995977|pmid=23919769}}{{Citation|title=Apolipoprotein E|date=2020-09-05|url=https://en.wikipedia.org/w/index.php?title=Apolipoprotein_E&oldid=976844671|work=Wikipedia|language=en|access-date=2020-09-11}}{{Cite journal |last1=Tolar |first1=Martin |last2=Hey |first2=John |last3=Power |first3=Aidan |last4=Abushakra |first4=Susan |date=June 2021 |title=Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer's Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression |journal=International Journal of Molecular Sciences |language=en |volume=22 |issue=12 |pages=6355 |doi=10.3390/ijms22126355 |pmid=34198582 |pmc=8231952 |issn=1422-0067|doi-access=free }}
Alzheon completed a $50 million Series D in April 2022 and will use the funds to complete ALZ-801 clinical trials.{{Cite news |last=Gormley |first=Brian |date=2022-04-14 |title=Alzheimer's Drug Developer Alzheon Secures $50 Million |language=en-US |work=Wall Street Journal |url=https://www.wsj.com/articles/alzheimers-drug-developer-alzheon-secures-50-million-11649935800 |access-date=2022-04-21 |issn=0099-9660}}