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Alzheon, Inc makes presentation of data from three studies of ALZ 801, a proposed treatment for Alzheimers Disease at the AAIC meeting.

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Last updated: 20th Jul 2017
Published: 20th Jul 2017
Source: Pharmawand

Alzheon, Inc.,announced data from the company�s three presentations at the Alzheimer�s Association International Conference (AAIC) held in London on July 16-20, 2017. These presentations at AAIC represent the convergence of research efforts by Alzheon for ALZ 801, an anti-amyloid drug candidate that is an optimized prodrug of tramiprosate, with R&D findings that range from the discovery of a novel molecular mechanism of action, to long-term clinical efficacy data in patients with Alzheimer�s disease (AD).

Together, these analyses confirm a Precision Medicine approach with ALZ 801 by showing the clinical efficacy of tramiprosate in a genetically-defined subpopulation of patients with apolipoprotein E4 (APOE4) genotype, and aligning the role of APOE4 and beta amyloid pathology in AD, through the following key observations: 1.The largest efficacy signal of tramiprosate was shown in patients with two APOE4 alleles (APOE4/4 homozygotes) with Mild AD, in Phase III studies of oral tramiprosate; 2. Tramiprosate inhibits formation of beta amyloid oligomers at clinically relevant concentrations achieved in AD patients, through a novel mechanism of �enveloping� the native amyloid peptide; 3. Soluble toxic beta amyloid oligomers play a key role early in the AD process, and this is intensified in APOE4/4 patients who have a higher burden of oligomers compared to APOE4 non-carriers.

Alzheon will also make a presentation on new clinical analyses supporting the company�s Precision Medicine clinical program for ALZ 801, further expanding on Alzheon�s body of research from previous tramiprosate Phase III studies showing an APOE4 gene dose effect, with the largest clinical benefit observed in APOE4/4 homozygotes. Alzheon will present details from the recently-published analyses of Phase III data that showed the largest efficacy signals of tramiprosate in APOE4/4 homozygous patients with Mild Alzheimer�s disease. In addition, at the AAIC, Alzheon will present analyses of efficacy and safety in APOE4/4 homozygotes with AD from the Phase III studies who continued into an Extension Study for an additional 52 weeks, when all subjects received high dose of tramiprosate. Results from the Extension Study showed that APOE4/4 AD subjects who received 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), suggesting a disease-modification effect.

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