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.
Pipeline
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.”