Alzheon Secures $100M Series E for ALZ-801 Alzheimer's Treatment

FRAMINGHAM, Mass.-- Alzheon, Inc., a biopharmaceutical company focused on therapies for Alzheimer's disease and other neurodegenerative disorders, has secured $100 million in Series E funding. The financing round was led by Alerce Medical Technology Partners, complementing a previous $50 million raised in Series D in 2022.

Founder, President, and CEO of Alzheon, Martin Tolar, MD, PhD, highlighted the significant progress the company has made in developing their novel oral Alzheimer’s treatment, ALZ-801. He emphasized that raising $150 million in the recent financing rounds reflects strong investor confidence in their innovative approach. Tolar noted that ALZ-801 has a favorable safety profile and has shown no increased risk of vasogenic brain edema in over 3,000 patients. This positions ALZ-801 to potentially become the first oral disease-modifying therapy for Alzheimer’s disease.

ALZ-801 (valiltramiprosate) is an oral medication currently in Phase 3 development for early Alzheimer’s disease. It works by inhibiting the formation of neurotoxic beta amyloid oligomers, which are linked to cognitive decline. The drug has demonstrated promising clinical efficacy, particularly in patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who are at the highest risk of developing Alzheimer’s. This group is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial, expected to conclude in 2024.

Muneer Satter, Founder and Managing Partner of Alerce Medical Technology Partners, expressed excitement about supporting Alzheon. He noted that ALZ-801 represents a significant advancement in the Alzheimer’s treatment landscape, with potential approval anticipated in 2025.

ALZ-801 is under evaluation in two clinical trials involving early Alzheimer’s patients. One trial, a two-year Phase 2 biomarker study with 84 participants, including 31 APOE4/4 homozygotes, was completed in late 2023. This trial is currently in a fourth-year extension following positive core results. The pivotal Phase 3 APOLLOE4 study screened over 6,000 patients and enrolled 325 subjects. Results from this trial are expected in the third quarter of 2024, with Alzheon planning a New Drug Application (NDA) submission the same year.

Ken Mace, Chief Financial Officer of Alzheon, stated that the recent funding ensures sufficient capital to complete their pivotal Phase 3 program and prepare for the commercialization of ALZ-801. The drug aims to slow the progression of Alzheimer's disease, and the Phase 3 trial results will be crucial for the potential NDA filing and subsequent U.S. commercial launch in 2025.

ALZ-801 is described as a first-in-class, investigational oral agent designed to block the formation of neurotoxic amyloid oligomers. It has received Fast Track designation from the U.S. Food and Drug Administration in 2017. Clinical trials have shown ALZ-801 to be effective and safe, with no increased risk of brain vasogenic edema. The initial Phase 3 program targets early Alzheimer’s patients with the APOE4/4 genotype, with potential expansion to other patient groups in the future.

Alzheon, Inc. is dedicated to developing innovative treatments for neurodegenerative disorders by addressing their underlying pathology. Their lead candidate, ALZ-801, has shown potential in blocking harmful amyloid formations in the brain, which are believed to contribute to cognitive decline. The company's focus on precision medicine aims to advance therapies with significant patient impact based on genetic and biomarker information.

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