Cantex and Headlamp Health Forge Strategic Partnership to Accelerate Azeliragon Development via Agentic Precision Neuropsychiatry for Severe Depression and Fatigue in Patients with Multiple Sclerosis

Headlamp's Lumos AI Platform to Apply Multifactorial Phenotyping to Identify Responder Patient Phenotypes Across a Population Underserved by Current Treatments

WESTON, Fla. and SAN FRANCISCO, May 13, 2026 /PRNewswire/ - Cantex Pharmaceuticals, Inc. ("Cantex"), a clinical-stage biopharmaceutical company, and Headlamp Health ("Headlamp"), an AI-native precision neuropsychiatry company, today announced a collaboration to apply Headlamp's Lumos AI™ platform to derisk and accelerate the clinical development of azeliragon for severe depression and fatigue in patients with multiple sclerosis ("MS").

Lumos AI is a neuro-symbolic, multi-agent platform purpose-built for neuropsychiatric drug development. The platform integrates biological, behavioral, biomarker, and clinical data into a unified intelligence layer, enabling development teams to identify responder/non-responder subtypes earlier, refine trial design and model patient trajectories that episodic data alone cannot capture. Fueled by more than 100 million longitudinal multi-modal data points, Lumos AI is designed to move drug development beyond population-level assumptions and toward more precise, individualized insight 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 the only oral, blood-brain barrier-penetrant clinical stage RAGE inhibitor in clinical development, and it directly targets the neuroinflammatory biology driving depression and fatigue in MS patients. In MS, RAGE is expressed in the brain on microglia, astrocytes, endothelial cells, and infiltrating immune cells, where activation by ligands including HMGB1 and S100 proteins amplifies neuroinflammatory signaling. Approximately 40% of patients with progressive MS have clinically significant depression, and fatigue affects 60% to 80% of MS patients over the course of the disease. Both symptoms are pharmacologically underserved, with current options showing limited efficacy beyond placebo. Because depression and fatigue reflect overlapping inflammatory, clinical, and behavioral drivers, patient stratification is central to a targeted treatment approach.

Under the terms of the collaboration, Headlamp Health will deploy Lumos AI to analyze the comprehensive body of data generated across azeliragon's development program. This agentic intelligence layer integrates multi-modal signatures to delineate distinct responder and non-responder phenotypes. Headlamp's Lumos AI platform enables the identification of distinct patient phenotypes and determination of who is most likely to benefit from treatment.

"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."

To learn more about Headlamp Health or Lumos AI, please visit https://www.headlamp.com/.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation endproducts (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer's disease by vTv Therapeutics Inc. from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2,000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

About Cantex Pharmaceuticals

Cantex Pharmaceuticals is a clinical-stage biopharmaceutical company developing azeliragon, a clinical-stage oral RAGE inhibitor, for major depressive disorder and fatigue in patients with multiple sclerosis. Cantex is led by Stephen Marcus, M.D., who played a leading role in the development of Betaseron®, the first disease-modifying therapy approved for MS, and oral cladribine (Mavenclad®). Betaseron® and Mavenclad® have been administered to over 200,000 patients with MS worldwide. For more information, visit www.cantex.com.

About Headlamp Health

Headlamp Health is an AI-native, San Francisco-based company that has launched Lumos AI, the first agentic, neuro-symbolic platform purpose-built for precision neuropsychiatry. Fueled by a proprietary data moat of 100M+ longitudinal multi-modal data points, Lumos AI delivers a specialized reasoning layer that consistently outperforms general-purpose models in clinical comprehensiveness and epistemic calibration. Our vertically integrated intelligence stack de-risks R&D by identifying multifactorial biomarker signatures and responder-rich phenotypes, while simultaneously providing clinicians with real-time, precision treatment decision support. Currently validated through active pharmaceutical partnerships and supporting over 150,000 patients, we are architecting workflows to replace trial-and-error medicine with the right drug for the right patient at the right time. For more information, visit www.headlamp.com.

About vTv Therapeutics
vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv's clinical pipeline is led by cadisegliatin, currently in a U.S. Phase 3 trial, a potential first-in-class oral glucokinase activator being investigated for the treatment of type 1 diabetes. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn or X.

Media Contact:
Headlamp Health,
Delia Mendoza,
[email protected]
(310) 500-9273

SOURCE Headlamp Health