Alzheon, a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, announced that it has raised $100 million in Series E financing, led by Alerce Medical Technology Partners. And Alzheon previously raised $50 million in Series D funding a couple of years ago.
ALZ-801 (valiltramiprosate) is a first-in-class, investigational oral disease-modifying therapy in Phase 3 development for treating early Alzheimer’s disease. And in mechanism-of-action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose. ALZ-801 has shown potential for robust clinical efficacy in the highest-risk AD population – patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), and favorable safety with no increased risk of brain vasogenic edema. This population is the focus of Alzheon’s pivotal Phase 3 APOLLOE4 trial, which is fully enrolled and will be completed later this year.
ALZ-801 is currently being evaluated in two clinical trials in Early AD subjects. And a two-year, 84-patient, Phase 2 biomarker study comprising APOE4 carriers, including 31 APOE4/4 homozygotes was completed in the second half of last year. This Phase 2 biomarker trial is currently completing a fourth-year extension following positive results from the core portion of the study. The pivotal APOLLOE4 Phase 3 study of APOE4/4 homozygotes, which screened over 6,000 patients and enrolled 325 subjects, will complete and read out in the third quarter of 2024. Alzheon is planning for NDA submission in 2024.
KEY QUOTES:
“Alzheon has experienced tremendous progress in the past year and the promise of our novel oral Alzheimer’s treatment, ALZ-801, has attracted prominent institutional and private investors. Our ability to raise $150 million over the last two financing rounds in the current climate speaks volumes about the prospects of our innovative science and technology. We are at the dawn of a new era in the treatment of Alzheimer’s disease, and our novel therapeutic approach has an opportunity to transform the standard of care and improve access to treatment for all Alzheimer’s patients. Our well-differentiated drug candidate with a favorable safety profile, showing no increased risk of vasogenic brain edema in more than 3,000 AD patients, is positioned to potentially become the first oral disease modifying therapy for the treatment of Alzheimer’s disease.”
- Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon
“At Alerce, we focus on investing in companies in the late stages of development that are developing lifesaving drugs or devices with the potential to benefit millions of patient lives. Alzheon’s ALZ-801 provides an innovative precision-medicine solution in an emerging Alzheimer’s pipeline with a path to potential approval in 2025. We are incredibly excited to support the Alzheon team in their latest round of financing.”
- Muneer Satter, Founder and Managing Partner of Alerce Medical Technology Partners
“This latest fundraising ensures that we will have sufficient capital to complete our pivotal Phase 3 program and prepare commercialization of oral ALZ-801/valiltramiprosate with runway well into 2026. ALZ-801 has the potential to disrupt the Alzheimer’s treatment paradigm by slowing the progression of this relentless and debilitating disease, and the results from our pivotal APOLLOE4 Phase 3 trial will set the stage for the potential NDA filing this year, followed by the U.S. commercial launch in 2025.”
- Ken Mace, Chief Financial Officer of Alzheon
