Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha
Cognition,” or the “Company”), a biopharmaceutical company
committed to developing novel therapies for people with
debilitating neurodegenerative disorders, today announced positive
results from a bioequivalence study with ALPHA-1062, a proprietary,
delayed release oral tablet formulation in development for the
treatment of mild to moderate Alzheimer’s Disease (AD).
The company elected to conduct this additional study which was
designed to demonstrate pharmacokinetic (PK) equivalence between
5mg ALPHA-1062 delayed release tablets and 8 mg galantamine
hydrobromide extended release (ER) capsules. These data, coupled
with the positive pivotal data released in June, establish
bioequivalence to both formulations of galantamine hydrobromide and
strengthen the NDA application for ALPHA-1062 in mild-to-moderate
AD, planned for Q2 2023.
The study was a two-treatment, two-period, crossover study
wherein 40 subjects were randomly assigned 1:1 to either treatment
with ALPHA-1062 5mg twice daily, or galantamine hydrobromide 8mg ER
capsules once daily, for 7 days. After a one-week washout period,
subjects were then crossed over to the other treatment arm and
dosed for 7 days.
Topline results confirmed that in healthy adult volunteers
treated to steady state, ALPHA-1062 was bioequivalent to
galantamine hydrobromide ER. In the pre-specified primary analysis,
ALPHA-1062 achieved area-under-the-curve and peak exposures of
approximately 107% and 127%, respectively, compared to those
generated by galantamine hydrobromide ER. As expected, Cmax results
for ALPHA-1062 is bracketed between galantamine hydrobromide IR and
ER (lower than IR, higher than ER) providing a robust and enhanced
data set for the NDA filing. These data further describe the
delayed release profile of ALPHA-1062 and strengthen the NDA data
set by characterizing the therapeutic and acceptable exposures
compared to both the immediate release and extended release
products.
Cedric O’Gorman, MD, Chief Medical Officer of Alpha Cognition,
commented, "We are delighted with these additional positive
registrational bioequivalence results from our second study of our
lead asset, ALPHA-1062, which further strengthens our NDA filing.
We have successfully demonstrated that ALPHA-1062 is bioequivalent
to two different release formulations of galantamine hydrobromide,
the immediate release and the extended release. ALPHA-1062, a
prodrug of galantamine, was designed to limit gastrointestinal side
effects and, if approved, could provide a meaningful advancement
for patients with Alzheimer’s Disease.”
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical
company dedicated to developing treatments for patients suffering
from neurodegenerative diseases, such as Alzheimer's disease and
Amyotrophic Lateral Sclerosis (ALS), for which there are limited
treatment options.
ALPHA-1062 is a patented new chemical entity being developed as
a new generation acetylcholinesterase inhibitor for the treatment
of Alzheimer's disease, with expected minimal gastrointestinal side
effects. ALPHA-1062's active metabolite is differentiated from
donepezil and rivastigmine in that it binds neuronal nicotinic
receptors, most notably the alpha-7 subtype, which is known to have
a positive effect on cognition. ALPHA-1062 is also being developed
in combination with memantine to treat moderate to severe
Alzheimer's dementia and as an intranasal formulation for traumatic
brain injury.
ALPHA-0602 (Progranulin) is expressed in several cell types in
the central nervous system and in peripheral tissues, promotes cell
survival, regulates certain inflammatory processes, and plays a
significant role in regulating lysosomal function and microglial
responses to disease. Its intended use for the treatment of
neurodegenerative diseases has been patented by the Company and
Alpha-0602 has been granted an Orphan Drug Designation for the
treatment of ALS by the FDA. ALPHA-0702 and ALPHA-0802 are Granulin
Epithelin Motifs, or GEMs, derived from full length progranulin
which have therapeutic potential across multiple neurodegenerative
diseases. GEMs have been shown to be important in regulating cell
growth, survival, repair, and inflammation. Alpha-0702 and
ALPHA-0802 are designed to deliver this with potentially lower
toxicity, and greater therapeutic effect.
Neither TSX Venture Exchange (the “TSX-V”), OTC Markets Group,
nor the TSX-V’s Regulation Services Provider (as that term is
defined in policies of the TSX-V) accepts responsibility for the
adequacy or accuracy of this release.
Forward-looking Statements
This news release is not, and under no circumstances is to be
construed as, an advertisement or a public offering of securities.
No securities commission or similar authority in Canada or in any
other jurisdiction has reviewed or in any way passed upon this news
release or the merits of the securities described herein and any
representation to the contrary is an offence.
This news release includes forward-looking statements within the
meaning of applicable securities laws. Except for statements of
historical fact, any information contained in this news release may
be a forward-looking statement that reflects the Company’s current
views about future events and are subject to known and unknown
risks, uncertainties, assumptions and other factors that may cause
the actual results, levels of activity, performance or achievements
to be materially different from the information expressed or
implied by these forward-looking statements. Forward-looking
statements can be identified by the words “may,” “might,” “will,”
“could,” “would,” “should,” “expect,” “intend,” “plan,”
“objective,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “target,” “seek,” “contemplate,” “continue”
and “ongoing,” or the negative of these terms, or other comparable
terminology intended to identify statements about the future.
Forward-looking statements in this news release include statements
regarding the Company’s business strategy, market size, potential
growth opportunities, capital requirements, clinical development
activities, the timing and results of clinical trials, regulatory
submissions, potential regulatory approval and commercialization of
the technology. Although the Company believes that we have a
reasonable basis for each forward-looking statement, we caution you
that these statements are based on a combination of facts and
factors currently known by us and our expectations of the future,
about which we cannot be certain. The Company cannot assure that
the actual results will be consistent with these forward-looking
statements as a result of known and unknown risks, uncertainties,
assumptions and other factors. These risks, uncertainties,
assumptions and other factors include those associated with
clinical studies and manufacturing, as well as development and
commercialization of the Company’s products; the need for
additional financing to maintain operations; risks posed by the
economic and political environments in which the Company operates
and intends to operate; market instability due to the COVID-19
pandemic; the potential for losses arising from the expansion of
operations into new markets; increased competition; assumptions
regarding market trends and the expected demand and desires for the
Company’s products and proposed products; reliance on industry
manufacturers, suppliers and key personnel; the failure to
adequately protect intellectual property; a failure to adequately
manage future growth; adverse market conditions; and failure to
satisfy ongoing regulatory requirements or obtain regulatory
approvals. These forward-looking statements speak only as of the
date of this news release and, other than as required by applicable
securities laws, the Company undertakes no obligation to revise or
update any forward-looking statements, even if new information
becomes available in the future.
This news release may also contain estimates and other
statistical, market and industry data from independent parties or
made by the Company relating to our industry. This data involves a
number of assumptions and limitations, and you are cautioned not to
give undue weight to such estimates. We cannot guarantee the
accuracy and completeness of information from third party
sources.
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version on businesswire.com: https://www.businesswire.com/news/home/20220822005115/en/
For further information: Bristol Investor Relations Stefan
Eftychiou 905 326 1888 ext 6 stefan@bristolir.com
https://www.alphacognition.com/
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