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 two presentations at the 9 th Annual Clinical Trials on Alzheimer's Disease (CTAD) congress in San Diego, California, to be held on December 8-10, 2016. After the recent publication of clinical analyses from Phase 3 tramiprosate studies showing promising efficacy in Alzheimer's disease (AD) patients homozygous for the epsilon 4 allele of apolipoprotein E (APOE4/4 patients), 1 the new analyses to be presented at CTAD build further on this data and help refine the target population for future confirmatory studies. An oral presentation will present analyses from the Phase 3 studies in the overall population and Mild AD subgroup of patients with the APOE4/4 genotype, and reveal an efficacy profile suggestive of disease modification in the Mild subgroup of AD patients. In a poster presentation, Alzheon will describe results from ALZ-801 clinical studies, including studies demonstrating the improved tolerability and pharmacokinetics of ALZ-801 in comparison to oral tramiprosate, as well as establishing a dose that achieves equivalent target drug exposure. The completed ALZ-801 Phase 1 bridging program supports the pivotal clinical program for development of ALZ-801, an optimized prodrug of tramiprosate, as an oral, amyloid-targeted drug candidate for the treatment of Alzheimer's disease (AD). The details for the presentations are as follows: Oral Presentation (OC-47) Title: "Tramiprosate Efficacy in APOE4 Carriers with Mild to Moderate AD: Sensitivity Analyses by Baseline Severity Suggest Large Effects in Homozygous Subjects with Mild AD" Date: Friday, December 9, 2016 Time: 4:30 pm (Pacific Time) Presenter: Susan Abushakra, MD, Chief Medical Officer, Alzheon, Inc. Authors: Susan Abushakra, MD, Alzheon, Inc., John Hey, PhD, Alzheon, Inc.; Aidan Power, MD, Alzheon, Inc.; Peter Wang MS, Pharmapace, Inc.; Larry Shen PhD, Pharmapace, Inc., Suzanne Hendrix PhD, Pentara Corporation; Serge Gauthier, MD, FRCPC, McGill University and Montreal Neurological Institute; Bruno Vellas, MD, PhD, University of Toulouse, France; Anton P. Porsteinsson, MD, University of Rochester Medical Center; Miia Kipivelto, MD, PhD, Karolinska University Hospital, Stockholm, Sweden; Martin Tolar, MD, PhD, Alzheon, Inc. Poster Presentation (P2-20) Title: "Phase 1 Program of ALZ-801, a Novel Pro-drug of Tramiprosate with Improved Tolerability: Supports Bridging to Upcoming Phase 3 Program" Date: Friday, December 9, 2016 Time: 10:00 - 10:30 am, 12:30 - 1:30 pm, and 3:30 - 4:00 pm (Pacific Time) Presenter: John Hey, PhD, Chief Scientific Officer, Alzheon, Inc. Authors: John Hey, PhD, Alzheon, Inc.; Mark Versavel, MD, PhD, Alzheon, Inc.; Susan Abushakra, MD, Alzheon, Inc.; Aidan Power, MD, Alzheon, Inc.; Paul L. Kaplan PhD, Alzheon, Inc.; Martin Tolar, MD, PhD, Alzheon, Inc. 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.
1 Abushakra et. al. J Prev Alz Dis 2016; 3(4): 219-228. Advanced online publication: jpreventionalzheimer.com