PR83739

STUART, Fla., April 21, 2020 /PRNewswire=KYODO JBN/ --

Linical Company Limited (Linical) and Alpha Cognition Inc. (ACI) today

announced they have signed a partnering agreement whereby Linical will provide

strategic consulting services and regulatory guidance for Alpha-1062, a new

chemical entity aimed to penetrate the Alzheimer's disease market.

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Alpha-1062 is a patented new acetyl choline esterase inhibitor (AChEI) showing

a significant reduction in side effects common in all other AChEI approved

therapeutics. The product is being investigated in both an oral tablet and

nasal spray delivery system. In placebo controlled Phase 1 and 1b human trials,

the nasal formulation showed a decrease of over 90% in GI related adverse

events compared to an approved AChEI at similar dose levels (Razadyn(R)).

Parallel development programs are ongoing with targeted approval in the United

States in late 2022 or early 2023 with a subsequent approval in Japan.

Regulatory guidance provided by the US FDA indicate that pivotal clinical

trials can be initiated in late 2020. Similar meetings with Japan's PDMA were

held earlier in 2020 and indicated a similar timeline.

Linical, a mid-size contract research organization (CRO) working in CNS trials

across the globe, will provide services to include: regulatory consulting,

clinical trial support, post-marketing pharmacovigilance, medical information

and safety support, as well as assisting with ACI's post-marketing phase IV

programs. This development program will focus on the US and Japanese markets.

ACI's CEO, Ken Cawkell, commented that, "We selected Linical to be our drug

development partner for this program because of their strong footprint in Japan

and the US, as well as their robust clinical trials program." He went on to

say, "I was impressed with the organization's capabilities in CNS clinical

research and their attentiveness to our needs."

If proven effective in Alzheimer's, the enhanced delivery technology seen in

Alpha-1062 could be helpful to other therapeutic areas such as Huntington's

disease and schizophrenia.

"Alpha Cognition's program marks an exciting milestone in the field of

Alzheimer's research. Alpha-1062 is poised to fill the need for a more

effective drug with less side effects in Alzheimer's patients," said Vita

Lanoce, CEO of Linical Accelovance America. "We look forward to working with

Alpha Cognition on their complete development program in the US and Japan, and

we see the potential of this therapy in applications beyond Alzheimer's

disease."

About Alpha Cognition Inc.

Alpha Cognition Inc. (ACI) is engaged in neurological disease research and has

developed programs in Alzheimer's disease and amyotrophic lateral sclerosis

(ALS). For additional information about ACI's research programs, visit:

http://www.alphacognition.com.

-- Alpha-1062 is a patented new chemical entity that has shown efficacy

in preclinical and recently completed human clinical trials. It is

being developed as a new generation of acetylcholine esterase

inhibitor (AcEI) with minimal gastro-intestinal side effects and new

routes of administration. Alpha-1062 is differentiated from donepezil

and rivastigmine in that it appears to also sensitize neuronal

nicotinic receptors, most notably the alpha-7 subtype, which may have

a positive effect on the disease. The drug is entering pivotal

clinical trials later this year.

-- Alpha-602 (Progranulin) is a natural protein that is expressed in

several cell types in the Central Nervous System and in peripheral

tissues. Alpha-602 regulates cell survival and certain inflammatory

processes. The protein plays a major role in regulating lysosomal

function and microglial responses. Its use in the treatment of ALS has

been patented by ACI and is being investigated in preclinical models.

About Linical

Linical (

https://c212.net/c/link/?t=0&l=en&o=2781510-1&h=3111252742&u=https%3A%2F%2Fwww.accelovance.com%2F&a=Linical

) is a market-leading, public, midsized CRO with a significant footprint across

North America, Europe and Asia-Pacific. Linical is a global, full-service drug

development partner, uniquely capable of conducting large-scale, multinational

studies, while delivering personalized, hands-on service. Our areas of

expertise include Phase I-IV oncology, vaccine, infectious disease, CNS and

general medicine trials. We leverage regulatory consulting service, operational

knowledge and patient recruitment/retention strategies to support clients in

successful clinical trials.

Media Contacts

Linical

Alison Cundari

Director, Marketing & Corporate Communications

acundari@linical.accelovance.com

information@linical.accelovance.com

Alpha Cognition Inc.

For additional information about this press release contact:

rcarpenter@alphacognition.com

For additional information about the company contact: info@alphacognition.com

Or write to:

Investor Relations

Alpha Cognition Inc.

439 Helmcken Street,

Vancouver, B.C. V6B 2E6

SOURCE Linical