Cantex Pharmaceuticals and Headlamp Health have entered a collaboration aimed at advancing the clinical development of azeliragon for the treatment of severe depression and fatigue in patients with multiple sclerosis (MS). Through the agreement, Cantex and Headlamp will apply Headlamp’s Lumos AI platform to support patient stratification, optimize trial design, and accelerate development activities surrounding the investigational therapy. The platform combines biological, biomarker, behavioral, and clinical datasets into a unified intelligence framework intended to identify responder and non-responder patient groups earlier in the development process.
Lumos AI was developed specifically for neuropsychiatric drug development and is built on a neuro-symbolic, multi-agent architecture. According to the companies, the platform draws on more than 100 million longitudinal multi-modal data points to model patient trajectories and generate individualized insights that episodic datasets may overlook. The technology is designed to move drug development beyond broad population assumptions by enabling more precise analysis across neuropsychiatric conditions.
“Severe depression and fatigue are among the most debilitating aspects of MS, affecting approximately 40% of patients with progressive MS and in need of pharmacologic treatment that is more effective and safer than medications currently available. Having led the development of Betaseron®, the first disease-modifying therapy approved for MS, which has been followed by several other effective medicines for relapsing MS, we still need to address the symptoms that severely impact daily functioning, especially for progressive MS, for which current treatments need improvement. Azeliragon’s mechanism of action, inhibition of “RAGE” (the receptor for advanced glycation endproducts), directly addresses the neuroinflammatory pathways linked to depression and fatigue that SSRI and SNRI medications do not address,” said Stephen Marcus, M.D., Chief Executive Officer of Cantex Pharmaceuticals.
Azeliragon is described as the only oral, blood-brain barrier-penetrant clinical-stage RAGE inhibitor currently in development. In MS patients, RAGE is expressed on microglia, astrocytes, endothelial cells, and infiltrating immune cells within the brain, where activation by ligands such as HMGB1 and S100 proteins can intensify neuroinflammatory signaling. The companies noted that depression affects around 40% of patients with progressive MS, while fatigue impacts between 60% and 80% of individuals during the course of the disease. Existing pharmacological options continue to show limited efficacy beyond placebo, increasing the importance of targeted patient selection strategies.
Under the collaboration terms, Headlamp Health will deploy Lumos AI across the broader azeliragon development program to analyze multi-modal clinical signatures and identify patient phenotypes most likely to benefit from treatment. Cantex and Headlamp stated that the approach is intended to support a more precise development pathway for therapies targeting complex neuropsychiatric symptoms associated with MS.
“Lumos AI was built to reason across complex biological, clinical and longitudinal data so that drug development can move beyond broad populations and toward more precise patient phenotypes,” said Erwin Estigarribia, CEO of Headlamp Health. “This collaboration highlights how agentic AI can unlock insights within complex data and is exactly the use case we built for.”
