Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

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June
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Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by June »

I'm a new member as of June 10, 2024, and have introduced myself in a new member post (6/10/24). I'm 4/4 and 58, former biotech executive, asymptomatic but did notice some short memory loss.

I've been following Alzheon and their ALZ-801 trials for a while, like many of you, and excited to share this news! It's costly to conduct phase 3, secure regulatory approval, manufacture the drug, and prepare for the launch upon approval. The fact that Alzheon is able to secure $100 M private capital at this critical junction demonstrates the confidence of investors about Alzheon's management and its prospect of getting FDA's approval for and subsequent launch of a FIRST disease-modifying small molecule oral AD Rx - different from ALL approved Rx so far. It also demonstrated the huge unmet need in getting better AD therapeutics.

It's a fantastic news for all of us 4/4s who will be the first candidates to benefit from ALZ-801 upon FDA approval, both for those who are symptomatic immediately, and later for asymptomatic for prevention (which may take longer). I suspect 4/4s who are clinically asymptomatic but show biomarker pathology may even get off-label use upon approval, depending on supply. If Alzheon is successful in getting FDA approval, it will be well-positioned for an IPO, or acquisition by a major pharma with its own Rx (or late stage clinical candidates) in AD, like Eli Lilly.

Here is the news from Biospace:

Alzheon Raises $100 Million Series E Financing Round to Advance Development and Commercialization of Oral Tablet ALZ-801/Valiltramiprosate for Treatment of Alzheimer’s Disease

A major milestone worthy of celebration!
If any of you have further info about Alzheon and ALZ-801 trial progress, please continue to share ; ).

Cheers!

---------
June
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by squirrel320 »

Woo hoo.... as a 55 year old 4/4 with prodromal signs - enough to affect executive function and short term memory - this is super exciting. Thanks for sharing!
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by Downtown »

Great news. I take homo taurine now. Hopefully the prodrug will be even better.
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by June »

squirrel320 wrote: Thu Jun 13, 2024 9:57 am Woo hoo.... as a 55 year old 4/4 with prodromal signs - enough to affect executive function and short term memory - this is super exciting. Thanks for sharing!
You're welcome, squirrel320, let's hope all goes well for ALZ-801 phase 3 trial for 4/4s 8-)

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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

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Downtown wrote: Thu Jun 13, 2024 5:27 pm Great news. I take homo taurine now. Hopefully the prodrug will be even better.
Hi Downtown, how long have you taken homotaurine, what dose did you start and did you have to ramp up the dose gradually (over how long a period), any side effects, and what have you observed if you could share? I just ordered my 1st shipment last night and interested in hearing members' experience with it.

Thanks.

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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by Downtown »

I have taken it for over 6 months. No problems or side effects (which were very minor) after the first 2-3 weeks.

150mg (3 pills) 2 x a day with meals. I had some slight nausea at first along with tingling on the back of my neck. The nausea dissipated after 30-60 minutes. I titrated the dose for the first 2-3 weeks working up to the full dose. I believe the 150mg bid was the dosage used for the older clinical tests.

Good luck with this as early test results are that it works for E4/E4s. The company hopes to use it in a preventative way for E4's before we get MCI or early alzheimers. I am curious to see what the results are for the Phase 3 study schedule to be released in 3Q:2024.
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by floramaria »

June wrote: Thu Jun 13, 2024 6:27 pm I just ordered my 1st shipment last night and interested in hearing members' experience with it.
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Hi June, I don't know if you have discovered the Search function for this website yet (upper Right under your user name). I put in homotaurine and got this thread, among others: viewtopic.php?t=8611&start=70
The thread has many posts and discussion from people who have been experimenting with homotaurine; you might find it helpful.
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June
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by June »

Downtown wrote: Fri Jun 14, 2024 11:49 pm I have taken it for over 6 months. No problems or side effects (which were very minor) after the first 2-3 weeks.

150mg (3 pills) 2 x a day with meals. I had some slight nausea at first along with tingling on the back of my neck. The nausea dissipated after 30-60 minutes. I titrated the dose for the first 2-3 weeks working up to the full dose. I believe the 150mg bid was the dosage used for the older clinical tests.

Good luck with this as early test results are that it works for E4/E4s. The company hopes to use it in a preventative way for E4's before we get MCI or early alzheimers. I am curious to see what the results are for the Phase 3 study schedule to be released in 3Q:2024.
Thanks Downtown for detailed info! I'm glad you don't have side effects after 2-3 weeks. You didn't mention any positive effects, perhaps you haven't seen any cognitive deficiency to start with?

I'll share if I observe anything positive or negative after taking it myself, stay tuned...
June 4/4 yet hopeful
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by June »

floramaria wrote: Sat Jun 15, 2024 4:01 pm
June wrote: Thu Jun 13, 2024 6:27 pm I just ordered my 1st shipment last night and interested in hearing members' experience with it.
June, 4/4 yet hopeful
Former biotech exec
Hi June, I don't know if you have discovered the Search function for this website yet (upper Right under your user name). I put in homotaurine and got this thread, among others: viewtopic.php?t=8611&start=70
The thread has many posts and discussion from people who have been experimenting with homotaurine; you might find it helpful.
Thanks floramaria for the reminder, I did see homotaurine thread from Search function, but haven't seen anyone reporting "positive" improvement since taking homotaurine, unless I missed something?

For all who have/are experimenting with homotaurine, please do share whatever POSITIVE improvements if you have observed any 8-) Thanks!
June 4/4 yet hopeful
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Re: Alzheon Raises $100 Million to Advance ALZ-801 Development & Commercialization

Post by Glampers »

Hi June, welcome to the site. I read your introduction and it's wonderful that you bring so much background, knowledge, and insight into drug development! Thank you for sharing your story.

I am a fellow 58 year old woman and 4/4. My mother's family was devastated by early cardiovascular disease, then dementia, while my father's side has no dementia at all. My 4/4 status came as a shock to me. My beloved mother died of breast cancer before she was 60.

I am asymptomatic (but amyloid +) and taking homotaurine based on what I learned from this site - I take 100 mg in the evening to avoid experiencing nausea while awake. I have been doing so for about 6 months. I don't have any other side effects and have not experienced cognitive decline. The supplement is available in the US from a supplement company called SuperSmart. I plan to up my dose to 150 mg if I can tolerate it.

Like others I have struggled mightily on the emotional front following the release of the Fortea paper in Nature Medicine. I read a stoic philosophy tenet called Amor Fati which has helped me. It emphasizes that since life is not really in our control, we can only choose to embrace the deck of cards we are dealt and focus on who we choose to be as a person within that fate. I have come up with a list of things I want to do on that front: contribute to science, support others, and be the best friend and family member I can be in my remaining years of life and health. It helps me to think of this every morning as a sort of mantra.
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