Alzheon
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

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

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

  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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