Phase 1b Multiple Dose‐Ranging Study and Tablet Bioequivalence Study Will Provide Clinical Dose and Tablet Formulation Data to Support ALZ‐801 Phase 3 Program
FRAMINGHAM, Mass., November 6, 2015 – 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 the initiation of two clinical studies with ALZ‐801. ALZ‐801 is a prodrug of tramiprosate, which is a first‐in‐class small molecule inhibitor of amyloid formation and neurotoxicity, being developed for the treatment of Alzheimer’s disease. These studies will provide final clinical data necessary to progress ALZ‐801 into the Phase 3 program.
“With the robust body of existing positive clinical data in hand, we believe these studies represent the last clinical steps before we start the pivotal Phase 3 clinical study with our amyloid‐targeting drug candidate ALZ‐801 in Alzheimer’s disease,” explained Martin Tolar, MD, PhD, Founder, President and Chief Executive Officer of Alzheon. “Building on the existing positive results related to ALZ‐801 which include the extensive clinical evidence from its active compound tramiprosate, we have designed ALZ‐801 to offer a unique approach and potentially transformative treatment for patients with Alzheimer’s disease. We are excited about the prospects for ALZ‐801, as we have optimized its pharmacokinetic and tolerability profile, and designed our clinical plan building on the subgroup analysis of the Phase 3 studies with tramiprosate that showed compelling efficacy results in apolipoprotein E4 positive Alzheimer’s disease subjects.”
The Phase 1b multiple dose‐ranging trial is a randomized, double‐blind, placebo‐ controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of oral ALZ‐801 in healthy elderly volunteers.
The tablet bioequivalence Phase 1b study is a solid dose formulation study to examine the pharmacokinetics and food effect of a prototype tablet formulation with a single oral dose of ALZ‐801 in healthy elderly volunteers, to guide development of final drug product formulation to be used in the Phase 3 trial and, ultimately, for commercial development.
Completion of these two clinical studies is expected by 1Q 2016.
About Alzheon Alzheon, Inc. is committed to developing innovative medicines for patients suffering from Alzheimer’s disease and other neurological and psychiatric disorders. Our lead clinical candidate, ALZ‐801, is a first in‐class, oral inhibitor of amyloid aggregation and neurotoxicity – hallmarks of Alzheimer’s disease. ALZ‐801 is an optimized, novel prodrug that builds on the established safety and efficacy profile of the active compound in clinical trials of more than 2,000 patients. Our mission is to apply our discovery platform and development experience to unlock new classes of therapeutics that make a difference in patients’ lives by directly addressing the underlying pathology of devastating neurodegenerative disorders.
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Kathryn Morris, The Yates Network
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