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Alzheon

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Alzheon
Company typePrivate
IndustryPharmaceutical
Founded2013
HeadquartersFramingham, Massachusetts, United States
Key people
Martin Tolar, MD, PhD (CEO)
Neil Flanzraich (Executive Chairman of the Board of Directors)
Websitewww.alzheon.com

Alzheon is an American clinical-stage biopharmaceutical company based in Framingham, Massachusetts.[1] The company is developing medicines for patients with Alzheimer's disease and other neurological and psychiatric disorders.[2]

History

[edit]

Alzheon was founded in July 2013 by Martin Tolar, MD, PhD, a veteran of Alzheimer's drug programs,[2] who serves as president and CEO of the organization.[3] Alzheon completed a $10 million Series A round of financing in April 2015[4][5] and started the Phase lb bridging clinical program for ALZ-801, which was completed in July 2016.[6][7]

In August 2018, Alzheon appointed former IVAX President Neil Flanzraich, JD, as Vice Chairman of Board of Directors.[8][9]

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[10][11]

Pipeline

[edit]

Alzheon's leading candidate, ALZ-801, is an oral prodrug of the active agent tramiprosate[12] that targets neurotoxic soluble amyloid oligomers,[13][14][15] and received Fast Track designation from the FDA in 2017.[10]

ALZ-801 oral tablet is being evaluated in Phase 2 biomarker study in early Alzheimer's disease patients with homozygous and heterozygous APOE4 genotype.[14]

ALZ-801 is also in Phase 3 clinical development for high-risk homozygous APOE4/4 patients with early Alzheimer's Disease.[10] Patients with two alleles of APOE4 have up to 20 times the risk of developing Alzheimer's disease.[16][17][18]

Alzheon completed a $50 million Series D in April 2022 and will use the funds to complete ALZ-801 clinical trials.[19]

References

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  1. ^ Young, Susan (Mar 10, 2016). "Startup Finds Hope in Second Look at "Failed" Alzheimer's Drugs". MIT Technology Review. Retrieved August 24, 2016.
  2. ^ a b Lash, Alex (11 March 2016). "Failed Alzheimer's Drug To Get Another Shot, If Investors Pony Up". Xconomy. Retrieved 29 April 2017.
  3. ^ Seiffert, Don (March 20, 2015). "Lexington's Alzheon gives its own Alzheimer's news to rival Biogen's". Retrieved August 23, 2016 – via Boston Business Journal.
  4. ^ Fidler, Ben (8 April 2015). "Alzheon Gets $10M to Take Castoff Alzheimer's Drug Into Pivotal Test". Xconomy. Retrieved 29 April 2017.
  5. ^ Billings, Mike (April 8, 2015). "In a Hot Market, Freestyle Capital Raises Larger Fund". The Wall Street Journal. Retrieved August 25, 2016.
  6. ^ "'Gene-dose' effect for Alzheon's ALZ-801, a drug targeting Alzheimer's". The Pharma Letter. Retrieved 29 April 2017.
  7. ^ Fernandes, PhD, Joana (31 March 2017). "Early Alzheimer's Patients with Risk Gene Respond to ALZ-801 in Studies". Alzheimer's News Today. Retrieved 29 April 2017.
  8. ^ "Alzheon Appoints Former IVAX President, Neil Flanzraich, JD, as Vice Chairman of Board of Directors". Bloomberg.com. 6 August 2018. Retrieved 2020-04-09.
  9. ^ "Alzheon Appoints Former IVAX President, Neil Flanzraich, JD, as Vice Chairman of Board of Directors". www.businesswire.com. 2018-08-06. Retrieved 2020-04-09.
  10. ^ a b c "Alzheon receives $47M NIH grant funding its phase III Alzheimer's study". www.bioworld.com. Retrieved 2020-09-11.
  11. ^ Gormley, Brian (2020-08-20). "Biotechs Tap Growing U.S. Government Support for Alzheimer's Research". Wall Street Journal. ISSN 0099-9660. Retrieved 2020-09-11.
  12. ^ Tolar, Martin; Abushakra, Susan; Hey, John A.; Porsteinsson, Anton; Sabbagh, Marwan (2020-08-12). "Aducanumab, gantenerumab, BAN2401, and ALZ-801—the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval". Alzheimer's Research & Therapy. 12 (1): 95. doi:10.1186/s13195-020-00663-w. ISSN 1758-9193. PMC 7424995. PMID 32787971.
  13. ^ Hey, John A.; Kocis, Petr; Hort, Jakub; Abushakra, Susan; Power, Aidan; Vyhnálek, Martin; Yu, Jeremy Y.; Tolar, Martin (2018-09-01). "Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain". CNS Drugs. 32 (9): 849–861. doi:10.1007/s40263-018-0554-0. ISSN 1179-1934. PMC 6153967. PMID 30076539.
  14. ^ a b "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". BioSpace. Retrieved 2022-04-05.
  15. ^ Tolar, Martin; Abushakra, Susan; Sabbagh, Marwan (January 2020). "The path forward in Alzheimer's disease therapeutics: Reevaluating the amyloid cascade hypothesis". Alzheimer's & Dementia. 16 (11): 1553–1560. doi:10.1016/j.jalz.2019.09.075. ISSN 1552-5260. PMID 31706733. S2CID 207844779.
  16. ^ Hauser, Paul S.; Ryan, Robert O. (October 2013). "Impact of Apolipoprotein E on Alzheimer's Disease". Current Alzheimer Research. 10 (8): 809–817. doi:10.2174/15672050113109990156. ISSN 1567-2050. PMC 3995977. PMID 23919769.
  17. ^ "Apolipoprotein E", Wikipedia, 2020-09-05, retrieved 2020-09-11
  18. ^ Tolar, Martin; Hey, John; Power, Aidan; Abushakra, Susan (June 2021). "Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer's Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression". International Journal of Molecular Sciences. 22 (12): 6355. doi:10.3390/ijms22126355. ISSN 1422-0067. PMC 8231952. PMID 34198582.
  19. ^ Gormley, Brian (2022-04-14). "Alzheimer's Drug Developer Alzheon Secures $50 Million". Wall Street Journal. ISSN 0099-9660. Retrieved 2022-04-21.
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