Alpha Cognition Inc (ACOG.C) has navigated the Alzheimers FDA process like a champ

People really don’t like pharma companies in Canada.

We’ve had some monster megacorporations come out of Canada in the pharma space, and the biotech space, and a lot of them turned out to be robber baron villains with twirly moustaches looking to monetize mom’s ailments in ways that ensure the highest possible return in the shortest possible amount of years she can have left.

And, I don’t know about you, but that’s not how I want to be able to afford a hot tub.

But there are companies out there that are actually doing good things in pharma tech – not just buying the rights to a thing and running up the price, but making said thing better for patients.

Let me give you an example.

My dad has dementia. It’s come on hard and fast lately, largely because his pit viper of a wife refused to let him be treated for several years for fear he might lose his drivers license. She watched him descend into mental vacuum because she didnt want to take taxis. It was gross.

So now he’s in care and on meds and those meds, let me tell you, are the worst. Half the patients that take them – HALF – experience chronic diarrhea, vomiting, insomnia, and other side effects that turn a long term care facility into a nightmare for both patients and staff.

Imagine there are 24 dementia patients on a ward and every night 12 of them need a clean up and cant sleep.

Added to which, many patients (about 1 in 5) akso have trouble swallowing as well, so even getting their meds down in the first place is a chore.

ENTER ALPHA COGNITION INC (ACOG.C).

In layman’s terms, the thinking is that Alpha Cognition’s drug, ALPHA-1062, will minimize those side effects, be far easier to administer, and let those folks suffering from dementia and Alzheimers get some actual sleep.

I don’t know about you, but I think that’s a noble cause and one I can fully get behind, because even if my dad wasn’t the target market for this, we ALL will be soon enough.

And it appears the US FDA is very interested in figuring out (quickly) if ALPHA-1062 is what it appears to be, because they’re actively talking to the company through the process in a way that one might expect if everyone were on the same team.

ALPHA-1062, in layman’s terms:

Now, a lot of people, at this point in a pharmaceutical story, switch off because when a drug is going through FDA trials etc, the terminology can be a little difficult to penetrate.

My job is to help avoid that, and put things in an easy to understand fashion so you can see EXACTLY where Alpha Cognition is on their journey, so let’s get to the bullet points.

THE SCORECARD:

Therapeutic Area: Neurodegenerative Diseases, specifically Alzheimer’s Disease.

Key Product in Development: ALPHA-1062

Development Overview:

1. Concept and Early Research:
   • Alpha Cognition has identified ALPHA-1062, a uniquely designed prodrug of galantamine, whichtargets Alzheimer’s Disease. The early research here focused on optimizing the therapeutic dose to minimize side-effects and improve long-term patient outcomes.
2. Pre-IND (Investigational New Drug):
   • The preparation for the IND submission likely involved pre-IND meetings with the FDA, development of the compound formulation, toxicology studies, and clinical trial protocols. That stuff takes years, and investors hate it because there’s no real clue when a company undergoing this stage of research will complete it, or if they’ll get positive results. A company dealt with this work before Alpha Cognition came along, but they poured millions of dolalrs in and years of work to get the result they were after.
3. IND Submission:
   • While specific details of the IND submission are not mentioned on the ACI materials I’ve looked at, ALPHA-1062 proceeded through this stage to begin clinical trials.
4. Phase 1 Clinical Trials:
   • The development of ALPHA-1062 would have necessitated initial human safety and dosage studies which the company rolled through successfully.
5. Phase 2 Clinical Trials:
   • ACI conducted studies to evaluate the efficacy and further assess the safety of ALPHA-1062, including bioequivalence studies versus immediate and extended-release forms of galantamine. In layman’s terms, here’s where you figure out if the drug responds poorly to other drugs, what dosage will be optimal – all the complex stuff that can derail the process entirely. Again, they rolled through this process with success.
6. Phase 3 Clinical Trials:
   • The pivotal trial results and bioequivalence studies provided the data that enabled the ALPHA-1062 New Drug Application (NDA) filing, indicating completion of Phase 3 requirements. This part is NOT EASY. It’s generally expensive and full of pitfalls. One mistake can push everything back a year plus, and by ‘mistake’ I mean tiny errors in process as much as actual poor results. Again, ACI rolled on through.
7. NDA (New Drug Application) Submission:
   • This is the big one for Alpha Cognition. The NDA for ALPHA-1062 was submitted in September 2023 and accepted by the FDA in December 2023, showcasing a well-prepared dossier based on thorough preclinical and clinical investigations. To be clear, it’s not irregular for the FDA to take a while before they pick up a new NDA. If they move quickly, the general consensus is they see a need for the drug in question. Three months is pretty swift. Another win for ACI.
8. FDA Review and Approval:
   • Alpha Cognition is currently in this stage, with FDA review ongoing and approval targeted for Q3/24. The company is preparing for commercialization by Q1/25, indicating they are actively engaged in the final stages of the regulatory process, and I’m told there hasn’t been any communications thus far that would indicate problems in that process. Of course, you never know if everything is going great, but you often know if it’s not. If approval comes as expected, this will be a big deal. A gamechanging moment 15 years plus in the making.
9. Post-Marketing Surveillance (Phase 4):
   • There’s a level after approval, where early use and sales are carefully watched to ensure things roll out as expected, so approval isn’t necessarily a green light to run ALPHA-1062 ads during MeTV’s Thursday night lineup of The Andy Griffiths Show and Car 54 Where Are You. Planning for post-marketing surveillance would commence following FDA approval, with strategies likely in place to monitor ALPHA-1062’s safety and efficacy in the general population.

Stage Determination:

• ACI is at Stage 8: FDA Review and Approval, based on their most advanced project, ALPHA-1062. This is a VERY advanced part of the timeline, and while it doesn’t mean things are without risk, it does mean a LOT of money and time and risk has been worked through to now be at a place where the company might dare look at its sales plans.

Deficiencies/Notes:

• There are no apparent deficiencies in the documentation or progression thus far. ACI has systematically navigated the regulatory pathway with ALPHA-1062 in a manner that suggests they know what the hell they’re doing.

The Sales Plan:

• Don’t expect to see ACI buying blocks of ads during CNN and in Inside Golf Magazine. The model here is to go out to long term care providers first, because they buy meds in bulk, administer them nightly, and have REAL COMMERCIAL IMPERATIVES to discontinue meds that run awful side effects and exhaust their staff.
• There are 65,000 regulated long term care facilities in the US, and Medicare and Medicaid provide 60%+ of the funding for that long term care, which is a much more accessible target market than going out to millions of individuals.

Coles Notes: Alpha Cognition Inc. has demonstrated significant advancement in developing ALPHA-1062, a novel treatment for Alzheimer’s Disease. The company has successfully completed clinical trials and submitted an NDA, which has been accepted by the FDA. ACI is now in the FDA review stage, with anticipation for product approval and subsequent commercialization. The thorough approach to the development and regulatory submission process showcases the company’s commitment to addressing the unmet needs in treating neurodegenerative diseases, particularly Alzheimer’s Disease.

The company currently sits on a CAD $119 million market cap, which I consider to be very undervalued considering US $50 million+ has gone into development of the drug over longer than a decade. They’ve just raised US$8.4 million in a rough market, they’ve filed their patent application for ALPHA-1062, and their stock is up more than double since December 2023.

I sat with the CEO, Michael McFadden, this week and the dude knows his detail. I have faith he’ll continue to pull this off, like he has to date.

This one’s for you, dad.

— Chris Parry

FULL DISCLOSURE: Not a client, but if I can help this kind of mission in any way, and help your grandma sleep a little better down the road, and we can all make a little dough while doing it, this was well worth my time. Might buy some Monday.