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Alzheon

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, valiltramiprosate (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. Susan Young. Startup Finds Hope in Second Look at "Failed" Alzheimer's Drugs MIT Technology Review, Mar 10, 2016, retrieved August 24, 2016^
  2. Alex Lash. Failed Alzheimer's Drug To Get Another Shot, If Investors Pony Up Xconomy, 11 March 2016, retrieved 29 April 2017^
  3. Don Seiffert. Lexington's Alzheon gives its own Alzheimer's news to rival Biogen's March 20, 2015, retrieved August 23, 2016^
  4. Ben Fidler. Alzheon Gets $10M to Take Castoff Alzheimer's Drug Into Pivotal Test Xconomy, 8 April 2015, retrieved 29 April 2017^
  5. Mike Billings. In a Hot Market, Freestyle Capital Raises Larger Fund The Wall Street Journal, April 8, 2015, 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. Joana Fernandes, PhD. Early Alzheimer's Patients with Risk Gene Respond to ALZ-801 in Studies Alzheimer's News Today, 31 March 2017, 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. Alzheon receives $47M NIH grant funding its phase III Alzheimer's study www.bioworld.com, retrieved 2020-09-11^
  11. Brian Gormley. Biotechs Tap Growing U.S. Government Support for Alzheimer's Research Wall Street Journal, 2020-08-20, retrieved 2020-09-11^
  12. Martin Tolar, Susan Abushakra, John A. Hey, Anton Porsteinsson, Marwan Sabbagh. 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, 2020-08-12^
  13. John A. Hey, Petr Kocis, Jakub Hort, Susan Abushakra, Aidan Power, Martin Vyhnálek, Jeremy Y. Yu, Martin Tolar. 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, 2018-09-01^
  14. 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. Martin Tolar, Susan Abushakra, Marwan Sabbagh. The path forward in Alzheimer's disease therapeutics: Reevaluating the amyloid cascade hypothesis Alzheimer's & Dementia, January 2020^
  16. Paul S. Hauser, Robert O. Ryan. Impact of Apolipoprotein E on Alzheimer's Disease Current Alzheimer Research, October 2013^
  17. Apolipoprotein E Wikipedia, 2020-09-05, retrieved 2020-09-11^
  18. Martin Tolar, John Hey, Aidan Power, Susan Abushakra. Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer's Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression International Journal of Molecular Sciences, June 2021^
  19. Brian Gormley. Alzheimer's Drug Developer Alzheon Secures $50 Million Wall Street Journal, 2022-04-14, retrieved 2022-04-21^