Clinical-stage biotech Alzheon has completed a $100 million Series E financing round to advance the development and commercialization of its oral drug for Alzheimer’s disease. The drug, called ALZ-801 (valiltramiprosate), is designed to inhibit the formation of soluble toxic beta amyloid oligomers, which are implicated in the cognitive decline observed in Alzheimer’s patients. The small molecule acts upstream of other late-stage amyloid-targeting treatments, offering a potentially more effective intervention by addressing the early formation of neurotoxic aggregates.
The new funding will be used to complete the current APOLLOE4 Phase 3 study to evaluate the efficacy and safety of ALZ-801 in patients with early Alzheimer’s disease. It will also support Alzheon’s plans to submit a New Drug Application (NDA) in 2024 based on the study’s outcomes, as well as preparing the manufacturing processes and commercial launch of ALZ-801, which is potentially the first oral disease-modifying therapy for Alzheimer’s.
“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,” said Ken Mace, CFO of Alzheon. “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.”
The pivotal APOLLOE4 Phase 3 study particularly targets patients with two copies of the APOE4/4 gene, a high-risk group that constitutes approximately 15% of Alzheimer’s patients, including actor Chris Hemsworth. The study, which has screened over 6,000 patients and enrolled 325 subjects, will conclude in the third quarter of 2024. Positive results could pave the way for regulatory approval and subsequent commercialization.
“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,” said Dr Martin Tolar, CEO of Alzheon. “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.”
In addition to the Phase 3 study, ALZ-801 has been evaluated in a two-year Phase 2 biomarker trial involving 84 patients, including 31 APOE4/4 homozygotes. This trial, completed in late 2023, is currently in a fourth-year extension phase. The study’s primary goal is to assess the effects of ALZ-801 on biomarkers of Alzheimer’s pathology, alongside its clinical efficacy, safety, tolerability, and pharmacokinetic profile over 208 weeks of treatment.
Alzheon envisions extending the use of ALZ-801 beyond APOE4/4 homozygotes to include patients with one copy of the APOE4 gene and even noncarriers. The company says it is also focusing on a future precision medicine approach, leveraging individual genetic and biomarker information to tailor therapies that offer the greatest benefit to specific patient subsets.
The funding round, which was led by Alerce Medical Technology Partners, follows a $50 million Series D round completed in 2022.
“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,” said Muneer Satter, Managing Partner of Alerce. “Alzheon’s ALZ-801 provides an innovative precision-medicine solution in an emerging Alzheimer’s pipeline with a path to potential approval in 2025.”
News
Why More People in Their 30s Are Suddenly Getting Colon Cancer
A major Swiss study found that colorectal cancer is becoming increasingly common in adults under 50, even as rates decline in older age groups. Researchers in Switzerland have identified a concerning trend: while colorectal [...]
Researchers Compare MS Models to Human Tissue in Search for Better Therapies
Researchers identified key differences between two widely used multiple sclerosis models, showing how each can better study myelin damage, immune responses, and repair. The findings may improve efforts to develop treatments that restore lost [...]
Scientists Discover Genetic “Off Switch” That Supercharges CAR T Cells Against Cancer
A new study reveals a possible way to make CAR T-cell therapy more durable and effective by targeting a single gene-regulating protein. CAR T-cell therapy is widely seen as a breakthrough in personalized cancer [...]
New Vitamin B12-Based Therapy Could Change How Brain Cancer Is Treated
Researchers have identified a vitamin B12–based compound that appears capable of crossing the blood–brain barrier and selectively accumulating in glioblastoma tissue. For decades, one of the biggest problems in brain cancer treatment has had [...]
Simple Fiber Supplement Cuts Knee Arthritis Pain in Just 6 Weeks, Study Finds
A daily inulin supplement may help reduce knee osteoarthritis pain while revealing a possible link between gut health, muscle function, and pain sensitivity. For millions of people living with knee osteoarthritis, managing chronic pain [...]
This Common Vitamin May Help Stop Prediabetes From Turning Into Diabetes
Vitamin D may help prevent type 2 diabetes in people with specific genetic variations, offering a possible path toward personalized diabetes prevention. More than 40% of U.S. adults have prediabetes, a condition in which [...]
Ebola, hantavirus: Is the world prepared for the next pandemic?
Funding cuts to health research and a growing antivaccine movement are making it harder than ever to respond to viruses. The World Health Organization (WHO) has declared that an Ebola outbreak in Uganda and [...]
May 2026 Healthcare News and Trends: Market Signals That Matter
Artificial intelligence is dominating headlines, telehealth has settled into a new normal, and digital health continues to promise transformation. However, much of what is being discussed in healthcare today reflects potential rather than reality. [...]
Scientists Rewire Donor Stem Cells To Outsmart Aggressive Blood Cancers
Researchers have tested a gene-edited stem cell transplant designed to shield healthy blood-forming cells from powerful cancer-targeting immunotherapies. For patients with highly aggressive blood cancers, stem cell transplantation can offer a rare chance at [...]
Recent Digital Health Trends, Insights and News – May 2026
Last month marked continued progress as digital health moves into its next phase — from AI expanding into drug discovery and core infrastructure to new federal pathways accelerating device access and home-based care. Together, [...]
Cancer Mystery Solved: Scientists Discover How Melanoma Becomes “Immortal”
Scientists have uncovered a previously overlooked mechanism that may help melanoma cells become effectively “immortal.” Cancer cells face a major problem before they can become deadly: They have to figure out how to stop [...]
How Visual Neurons Organize Thousands of Synaptic Inputs
Summary: A new study uncovered the organizational rules that determine how neurons in the primary visual cortex process information. By imaging both the cell bodies (soma) and the individual synapses (on dendritic spines) of [...]
Scientists Just Found a Surprising Way To Destroy “Forever Chemicals”
Scientists have uncovered a new mechanism that may help break down highly persistent PFAS pollutants. PFAS have earned the nickname “forever chemicals” for a reason. These industrial compounds are so chemically durable that they [...]
Scientists Discover Cheap Material That Kills Deadly Superbugs
A new sulfur-rich antimicrobial polymer shows strong effectiveness against fungal and bacterial pathogens and may offer an affordable solution to antimicrobial resistance. Antimicrobial resistance is creating growing challenges for both healthcare and food production, [...]
What to Know About Cicada, or BA.3.2, the Latest SARS-CoV-2 Variant Under Monitoring
Like periodical cicadas, the insects for which it is nicknamed, SARS-CoV-2 Omicron subvariant BA.3.2 is only just beginning to emerge after lying low for an extended period since it first appeared. Although it was [...]
Scientists Say This Simple Supplement May Actually Reverse Heart Disease
Scientists in Japan say a common supplement may actually help “unclog” certain diseased heart arteries from the inside out. A simple food supplement sold in Japan may have helped reverse a dangerous form of [...]
