New partnership uses AI to fast-track oral pill for MS depression and fatigue

Data analyzed to predict patients who will benefit most from azeliragon

Written by Marisa Wexler, MS |

A robot hand and a human hand hold a virtual AI icon.

A new collaboration will use AI to analyze data to help fast-track an oral treatment for MS-related depression and fatigue. (Photo from iStock)

  • AI is fast-tracking azeliragon, an oral treatment for multiple sclerosis depression and fatigue.
  • Severe depression and fatigue affect ~40% of progressive MS patients due to neuroinflammation.
  • Azeliragon blocks RAGE protein, targeting inflammation; AI identifies patients most likely to respond.

Cantex Pharmaceuticals and Headlamp Health are teaming up to fast-track an oral treatment for the debilitating depression and fatigue that affects many people living with multiple sclerosis (MS).

The partnership centers on the development of azeliragon, an experimental therapy. By leveraging Headlamp’s Lumus AI platform, the companies plan to analyze existing data to predict which MS patients are most likely to respond to the treatment, potentially reducing the risk of failure in upcoming clinical trials.

“Severe depression and fatigue are among the most debilitating aspects of MS, affecting approximately 40% of patients with progressive MS,” Stephen Marcus, MD, CEO of Cantex, said in a press release. He noted that these patients urgently need treatments that are safer and more effective than those currently available.

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Using AI to target MS symptoms

MS is a chronic disorder where inflammation damages cells in the brain and spinal cord, leading to a wide range of neurological symptoms. While many patients struggle with mental health issues, the majority also face fatigue, an overwhelming exhaustion that does not improve with rest.

These symptoms are believed to be driven by persistent inflammation in the nervous system, and are often poorly managed by existing medications. Researchers are looking for new ways to quiet that inflammatory response.

Azeliragon works by blocking a protein called RAGE, which plays a key role in the body’s inflammatory process. Originally developed by vTv Therapeutics for Alzheimer’s disease, the treatment did not succeed in that indication, but clinical trials involving more than 2,000 people demonstrated that it was well tolerated and safe for human use.

Cantex has since licensed the drug and is testing its potential for respiratory disorders and certain cancers. In the context of MS, the therapy is intended to target the specific biological pathways that lead to mood and energy issues.

“Azeliragon’s mechanism of action, inhibition of [RAGE], directly addresses the neuroinflammatory pathways linked to depression and fatigue that [available antidepressant] medications do not address,” Marcus said. He added that while current disease-modifying therapies can slow the overall progression of MS, symptoms such as depression and fatigue can still cause substantial issues for patients in their day-to-day lives.

One of the biggest challenges in clinical research is that symptoms like depression and fatigue vary widely between individuals. Differences in biology, lifestyle, and social support make it difficult for scientists to determine who will actually benefit from a given treatment.

Headlamp’s Lumus AI platform is designed to sift through massive amounts of neurological data to find patterns that human researchers might miss. Under the new agreement, the platform will be used to analyze the comprehensive dataset from azeliragon’s development program.

The goal is to identify who is most likely to respond to the therapy and help refine clinical trial design to include patients expected to derive the greatest benefit from azeliragon.

“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 [characteristics],” said Erwin Estigarribia, CEO of Headlamp Health. He noted that the partnership is a prime example of how AI can unlock insights within complex medical data.

Helen Moore Powell avatar

Helen Moore Powell

AI will never help MS Patients. Not everyone is depressed, no machine can predict that. Stem Cell Therapy needs to be fast tracked for PPMS patients. I'm all out of options. Ocrevus blew up a massive ulcer 2/3 the size of my stomach. Now have tons more commodities and the FDA takes it's time. MS Researchers came to this conclusion, Ocrevus is a dangerous drug. Still doesn't have FDA approval for PPMS patients.

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E avatar

E

How does this compare to provigil?

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Laura Frame avatar

Laura Frame

For example, i'm to breast and fatigued every day.Will this pill help me

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Minx Col avatar

Minx Col

All sounds good, but kill EBV will be a huge positive in MS

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