mk3 wrote: ↑Sat Jan 04, 2025 6:54 am
As for Alz-801, I have been looking for updates often on the APOLLOE4 phase 3 trial as results were supposed to come out in 2024. I was beginning to fear that the results may have not been positive & thats why there have been no updates.
The excerpt below if from press release I received via email today from Alzheon. I'm not an investor in the company; I just sent an email about 5 years ago and now get their press releases.
Alzheon has experienced tremendous progress in 2024 with many milestones, most notably, the completion of our pivotal Phase 3 APOLLOE4 trial evaluating Alzheimer’s patients with two copies of the APOE4 gene. In addition, we closed a $100M Series E round of funding and published four peer reviewed scientific articles. We now look ahead to 2025, which will include regulatory meetings, a potential NDA submission to the FDA, and additional studies for our portfolio....We will present the results from our pivotal APOLLOE4 Phase 3 trial at the valiltramiprosate symposium at the Alzheimer’s Disease Parkinson’s Disease (ADPD) Conference in Vienna in April 2025. We are excited about the potential for valiltramiprosate to fill a crucial unmet medical need and improve access for millions of patients with Alzheimer’s and look forward to working with regulatory authorities including FDA to bring valiltramiprosate to patients.
"NDA" is a New Drug Application for the FDA. The mention of "regulatory authorities" suggests that they may apply also to the European Medicines Agency (EMA) which is the EU equivalent of the FDA. Alzheon's CEO is from the Czech Republic and the early trials were done in Europe, I believe. The fact that they are presenting results in April in Vienna, rather than waiting for the larger Alzheimer’s Association International Conference in Toronto in July, suggests that they want to get the results out in the first quarter and then file for approval. Or file and have the results seen by a scientific audience soon. And "additional studies" sounds promising.