Vandria reports top-line findings from Phase I study of VNA-318

Vandria has revealed encouraging preliminary results from its first human Phase I trial assessing VNA-318, a compound targeting the central nervous system (CNS). The study was conducted to examine the drugs pharmacokinetics, safety, and tolerability in 92 healthy male volunteers, laying the groundwork for future research in Alzheimers disease.

VNA-318 is an orally administered, brain-penetrating small molecule with a dual mechanism of action. Its initial development focuses on addressing Alzheimers disease by targeting cognitive decline and loss of daily function. Additionally, the compounds mode of action may have potential benefits for other CNS-related conditions.

The biological target of VNA-318 has genetic links to multiple human disorders, including Alzheimers. In preclinical studies, the molecule showed rapid improvements in memory and cognition, alongside long-term effects such as reduced toxic protein build-up, lower neuroinflammation, and enhanced mitochondrial performance.

The randomized, double-blind trial tested both single and multiple ascending doses. No severe or serious adverse events were reported, and no participants discontinued due to side effects. Pharmacokinetic analysis indicated consistent absorption, a prolonged half-life, and dose-proportional exposure, supporting a once-daily administration regimen.

Vandria CEO Klaus Dugi commented: The results from our first-in-human trial of VNA-318 are extremely promising and meet all expectations for a Phase I study. The observed dose-dependent changes in a key biomarker for target engagement are particularly noteworthy and will guide our Phase II development plans. The combination of safety, tolerability, confirmed brain penetration, and supportive preclinical data strongly validates VNA-318s potential in treating Alzheimers disease.

Looking ahead, Vandria intends to pursue a Series B funding round in 2026 to support proof-of-concept Phase II trials. The company also plans to invest in its preclinical programs for liver, muscle, and lung disorders.

Author: Maya Henderson