What You Need to Know About Alzheon

What You Need to Know About Alzheon
December 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Alzheon is focused on developing treatments for patients with Alzheimer’s disease and other neurological and psychiatric disorders. Its lead drug candidate, ALZ-801, was acquired through an exclusive licensing agreement with Bellus Health of Quebec, Canada. The deal included a family of analogs, a drug development platform of chemotypes and clinical datasets.

ALZ-801 had been tested in 2,000 people by Bellus Health, but the drug did not show significant benefit. However, the company’s founder, Martin Tolar, believes he knows how to fix that. A reformulated version lasts longer in the body, which is believed to improve efficacy and prevent amyloid plaques from clumping around neurons.

Company Leadership
Martin Tolar—founder, president and chief executive officer of Alzheon. Prior to founding Alzheon, he was president and chief executive officer of Knome and president and chief executive officer at NormOxys. He was also chief scientific officer and chief business officer at CoMentis.

John Hey—chief scientific officer. Hey has spent more than 20 years in drug discovery and development at CoMentis and NormOxys, focusing on Alzheimer’s disease and oncology. He was senior vice president of discovery and preclinical drug development at CoMentis. Prior to CoMentis, he spent 18 years at the Schering-Plough Research Institute.

Susan Abushakra—chief medical officer. Prior to joining Alzheon, she was chief medical officer at Transition Therapeutics, and before that at Elan /Perrigo , where she led the development of ELND005, an amyloid-targeting small molecule developed for neuropsychiatric symptoms in Alzheimer’s disease and Down syndrome.

Aidan Power—vice president of program and portfolio management. Previously, he was vice president and head of PharmaTherapeutics Precision Medicine at Pfizer Global Research and Development.

Petr Kocis—vice president of preclinical development. Prior to joining Alzheon, Kocis was the Global Head of AstraZeneca ’s Discovery Capabilities & Sciences, Exploratory Chemistry.

Kenneth Mace—vice president of finance. Before Alzheon, Mace was vice director and senior project manager, group planning and special projects, with F. Hoffman-La Roche.

Company Financing
Alzheon received $3.05 million in debt financing in January 2015 from an unidentified lead investor. In April 2015, the company initiated a $10 million Series A financing round. The equity financing was led by Ally Bridge Group and included investments from new and existing investors. “The excitement in our company was reflected in the strong interest we have received for our Series A fundraising,” said Tolar in a statement, “which we designed to support our plans to initiate a pivotal study of ALZ-801 in Alzheimer’s disease.”

In July 2015, the company raised $6.91 million in debt financing with an unnamed investor.

The company’s lead product candidate, ALZ-801, is an oral inhibitor of amyloid aggregation and neurotoxicity, which are two fundamental components of Alzheimer’s disease. It is a prodrug of tramisprosate, a first-in-class molecule. In November 2015, the company initiated a Phase Ib multiple dose-ranging study and tablet bioequivalence study to evaluate safety, tolerability and pharmocokinetics of the drug.

“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 III clinical study with our amyloid-targeting drug candidate, ALZ-801, in Alzheimer’s disease,” said Tolar in a statement. “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.”

The two studies are expected to be completed in the first quarter of 2016.

Market Competition
There are a fair number of companies working in the Alzheimer’s space, although overall it’s an area of drug development that is a wasteland of failed clinical trials, with reportedly over 123 drugs having failed and been discarded. Notably, Biogen , with its biggest successes in the multiple sclerosis market, has recently doubled down on the Alzheimer’s arena.

Other companies working in this area with varying degrees of success include Paris-based AB Science, which has U.S. headquarters in Chatham, N.J., and AstraZeneca’s MedImmune entered into four collaborations with the University of Cambridge to focus on neurodegenerative diseases, such as Alzheimer’s, Parkinson’s and multiple sclerosis. AstraZeneca (AZN) also has a collaboration deal with Eli Lilly and Company to co-develop and commercialize a potential Alzheimer’s drug, AZD3293.

Dollars and Deals
In September 2014, Alzheon announced that the Japan Patent Office had issued a patent for ALZ-801 and methods of treating Alzheimer’s disease and other disorders. This builds on the U.S. patent for ALZ-801. In January 2014, the company announced that the European Patent Office issued a notification of intent for a patents for ALZ-801.

What to Look For
“In 2015, Alzheon completed preparations for a Phase III start with ALZ-801 and we plan to initiate registration program for highly targeted Alzheimer’s patients in 2016,” Tolar told BioSpace. “This puts the company on a trajectory to bring ALZ-801 through Phase III and to the market within the next five years for a high risk, genetically predisposed patient population with Alz

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ad range of neurodegenerative indications.”

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