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Alzheon to Present Novel Molecular Mechanism of Action and Long Term Clinical Efficacy Data for Lead Candidate ALZ-801 at the Alzheimer's Association International Conference
[June 22, 2017]

Alzheon to Present Novel Molecular Mechanism of Action and Long Term Clinical Efficacy Data for Lead Candidate ALZ-801 at the Alzheimer's Association International Conference


Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer's disease and other neurological and psychiatric disorders, today announced that the company will be making three presentations at the Alzheimer's Association International Conference (AAIC) to be held in London on July 16-20, 2017.

The presentations highlight Alzheon's discovery of the novel mechanism of action of tramiprosate, the active agent in optimized prodrug ALZ-801, blocking formation of toxic beta amyloid (Aß) oligomers, as well as the clinical translation of the molecular mechanism of action of tramiprosate to clinical effects in Alzheimer's disease (AD) patients. The company's precision medicine clinical program for ALZ-801 is further supported by recently published new analyses of Phase 3 data that shows the largest efficacy signals of tramiprosate in APOE4/4 homozygous patients with Mild Alzheimer's disease.1,2 This AAIC clinical presentation further analyzed efficacy and safety in APOE4/4 homozygotes with AD who continued into an Extension Study for an additional 52 weeks, where all subjects received high dose tramiprosate. APOE4/4 AD subjects receiving the high dose of tramiprosate over 130 weeks showed persistent efficacy, compared to subjects who had a delayed start on active drug (i.e., initial placebo-treated subjects). These clinical benefits in APOE4/4 AD patients are consistent with the key role Aß oligomers play in AD pathogenesis and the recently discovered molecular mechanism of tramiprosate, where tramiprosate inhibits Aß monomer aggregation and formation of toxic Aß oligomers at clinically relevant doses.3

The details for the presentations are as follows:





     

Title:

 

ALZ-801 Mechanism of Action: Stoichiometry of Beta Amyloid Anti-Oligomer Effect, PK/PD, and Clinical Dose Selection for Confirmatory Phase 3 Program in Alzheimer's Disease

Date:

Wednesday, July 19, 2017

Time:

9:30 am - 4:15 pm (BST)

Location:

S8, P4-585

Presenter:

John Hey, PhD, Chief Scientific Officer, Alzheon, Inc.
 

Title:

Novel Enveloping Mechanism of Action of ALZ-801: Conformational Stabilization of Beta Amyloid by a Small Molecule Results in Anti-Oligomer Activity

Date:

Wednesday, July 19, 2017

Time:

9:30 am - 4:15 pm (BST)

Location:

S8, P4-585

Presenter:

John Hey, PhD, Chief Scientific Officer, Alzheon, Inc.
 

Title:

Clinical Effects of Tramiprosate in APOE4 Homozygotes with Mild to Moderate Alzheimer's Disease (AD) are Sustained Over 130 Weeks: Results of a Phase 3 Extension Study

Date:

Sunday, July 16, 2017

Time:

9:30 am - 4:15 pm (BST)

Location:

S8 P1-052

Presenter:

Martin Tolar, MD, PhD, Founder, President and CEO of Alzheon, Inc.
 

1 Abushakra et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer's Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer's Disease, Published online June 22, 2017. jpreventionalzheimers.com22June2017

2 Abushakra et al: Clinical Benefits of Tramiprosate in Alzheimer's Disease Are Associated with Higher Number of APOE4 Alleles: The "APOE4 Gene-Dose Effect" Journal of Prevention of Alzheimer's Disease, October 2016; 3(4): 219-228. jpreventionalzheimer.com24Oct2016

3 Kocis, P et al: Elucidating the Aß42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer's Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, June 2017; 31(6): 495-509. https://link.springer.com/article/10.1007/s40263-017-0434-z

About Alzheon

Alzheon, Inc. is committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer's clinical candidate, ALZ-801, is a Phase 3-ready, first-in-class, small molecule oral inhibitor of amyloid aggregation and neurotoxicity - hallmarks of Alzheimer's disease. ALZ-801 is a novel prodrug that builds on the safety and efficacy profile of the active compound tramiprosate, which has been evaluated in clinical trials involving over 2,000 Alzheimer's patients. Our clinical expertise and technology platform is focused on developing drug candidates using a precision medicine approach based on individual genetic and biological information to advance therapies with the greatest impact for patients.


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