Alzheon raises $100m for Alzheimer's treatment

Alzheon, a clinical-stage biopharmaceutical company, has successfully raised $100 million in a Series E funding round. This investment will be pivotal for the development and commercialization of ALZ-801 (Valiltramiprosate), an oral tablet intended as a disease-modifying therapy for Alzheimer's disease (AD).

The Series E funding round was led by Alerce Medical Technology Partners and follows a $50 million Series D round completed in 2022. The newly acquired funds will be primarily allocated to finalizing the APOLLOE4 Phase III clinical trial. This crucial study aims to evaluate ALZ-801's efficacy in treating 325 early-stage AD patients, with results expected by the third quarter of 2024. Following the trial, Alzheon plans to submit a new drug application (NDA) to regulatory authorities.

ALZ-801 targets amyloid aggregates, which are toxic in their soluble form, making it a unique intervention that acts earlier in the disease process compared to other amyloid-targeting treatments. The recent financial boost will also support the manufacturing scale-up of ALZ-801 and prepare for its commercial launch. If successful, ALZ-801 could become the first oral disease-modifying therapy available for Alzheimer's disease.

The Phase III clinical dose of ALZ-801 has shown a complete blockade of neurotoxic soluble beta-amyloid oligomers formation. Additionally, ALZ-801 has demonstrated clinical efficacy in the highest-risk AD population, presenting a favorable safety profile without increasing the risk of brain vasogenic edema.

In addition to the ongoing Phase III trial, ALZ-801 was also assessed in a two-year Phase II biomarker study involving 84 patients, which concluded in late 2023. This biomarker study is now extending into its fourth year, providing further data to support ALZ-801’s long-term efficacy and safety.

Martin Tolar, the founder, president, and CEO of Alzheon, highlighted the company's remarkable progress over the past year. He noted that the innovative nature of ALZ-801 has attracted significant interest from both institutional and private investors. Tolar emphasized that raising $150 million across the last two financing rounds, amidst a challenging economic climate, underscores the strong prospects of Alzheon's scientific and technological endeavors.

Tolar also pointed out that ALZ-801’s well-differentiated safety profile, evidenced by no increased risk of vasogenic brain edema in over 3,000 AD patients, positions the drug as a potential breakthrough in Alzheimer's treatment. This favorable safety profile is a critical advantage as the company moves closer to bringing ALZ-801 to market.

The infusion of substantial capital and the subsequent advancements in ALZ-801’s clinical evaluation suggest promising developments in the fight against Alzheimer's disease. As Alzheon continues to push the boundaries of AD treatment with its innovative approach, the medical community and patients alike await the potential of ALZ-801 to transform the landscape of Alzheimer's therapy.