Vandria announces first subjects dosed in its first-in-human Phase 1 clinical trial of VNA-318 brain-penetrant mitophagy inducer
Lausanne, Switzerland – 18 December 2024 – Vandria SA, a company at the vanguard of mitochondrial therapeutics developing first-in-class small molecule mitophagy inducers, today announces that the first subjects have been dosed in its first-in-human clinical trial of its lead Central Nervous System (CNS) compound VNA-318. Readout of this combined single and multiple ascending dose trial is expected in the summer of 2025.
VNA-318 is an orally available first-in-class small molecule against a novel target to rejuvenate cells and treat age-related diseases through the induction of mitophagy. The target has strong genetic links to several human diseases including Alzheimer’s disease. It has a dual mode of action with an immediate improvement of memory, learning, and cognitive function, paired with long-term disease-modifying effects such as reduced neuroinflammation, less toxic protein aggregation, and improved mitochondrial function, as shown in pre-clinical models of Alzheimer’s and Parkinson’s disease. Toxicity studies have demonstrated VNA-318 has a wide safety window. A composition of matter patent covering VNA-318 and other compounds has been issued by the US Patent Office.
This Phase 1 randomized, double-blind trial is a combined single and multiple ascending dose trial of VNA-318, designed to assess safety, tolerability, pharmacokinetic and pharmacodynamic parameters in healthy male subjects. [VNA-318-01| ClinicalTrials.gov]
Klaus Dugi M.D., CEO of Vandria, said: “We are very excited about this pivotal moment as we become a clinical stage company. We believe that VNA-318 has the potential to address unmet medical needs like mild cognitive impairment associated with Alzheimer's disease, major depressive disorder, other diseases of the CNS, and potentially diseases beyond the CNS.”
Professor Li-Huei Tsai from MIT, member of Vandria's Scientific Advisory Board, said: "Since my first interaction with Vandria, I have been impressed with the breadth and depth of the preclinical data with VNA-318 which include consistent, dose-dependent efficacy in several models of neurodegenerative disease. I am very excited about Vandria taking this important step into clinical development of VNA-318 and thereby bringing it closer to patients who can potentially benefit from it."
VNA-318 Is being developed initially for patients with early-stage CNS and neurodegenerative disorders and is intended to improve cognition and limit memory loss progression. The global market for Alzheimer’s diseasealone is estimated at $6 billion and is expected to grow at a CAGR of 12% to 2035, driven by an aging population, improved diagnosis, and a growing awareness and understanding of the condition and its implications.
Vandria has closed a $32M Series A to fund this Phase 1 trial, its analysis, and to plan for the efficacy-focused Phase 1b / 2a trials of VNA-318 with the first expected to commence in Q1 2026 or earlier. In 2025, the company will seek to raise a Series B to fund the planned Phase 2 trials and to progress other pipeline compounds in non-CNS indications such as muscle, lung, and liver diseases.
