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Treatment of multiple sclerosis has come a long way since the first drugs were developed. Approved in 1993In the 31 years since then, progress has been made, with the first treatment approved in 2017. Primary progressive multiple sclerosis.
But when it comes to safety, none of these advances are perfect.
“All of the current treatments have some drawbacks,” says Daniel Vitt, CEO of ImmunoTherapeutics, a clinical-stage biotechnology company developing treatments for chronic inflammatory and autoimmune diseases.
Among the MS medications are: Biogen’s Tysabriwhich is associated with a fatal brain disease called progressive multifocal leukoencephalopathy. Other drugs have side effects, Regular monitoring This can lead to reduced cardiac and kidney function, creating stress for both patients and doctors.
Immune’s leading candidate, Bidfuludimus CalciumClinical trials have shown a “benign” safety and tolerability profile, as well as antiviral activity. Response to COVID-19.
In addition, Immunochem claims that the molecule has anti-inflammatory and neuroprotective properties, slowing the progression of the disease, preventing relapses and allowing patients to retain physical independence for longer.
“Worsening disability is a major unmet health care need,” Vitt said.
First Bidofludimus calcium activates target Null 1A neuroprotective transcription factor. Phase 3 Trials In relapsing MS, Phase 2 study Progressive multiple sclerosis and Phase 2 study In relapsing-remitting MS, which is currently in an open-label trial.
“This neuroprotective function associated with Nurr1 is novel and could be a breakthrough for people with MS,” Vitt said.
Three benefits
MS is a progressive neurodegenerative autoimmune disease that attacks the central nervous system. It is unpredictable, has many different forms, and progresses differently in each patient, but always The two main Pathological processes: local inflammation and neurodegeneration.
“They say it has a thousand faces, and while each individual case may be slightly different, the overall pattern is the same,” Vitt says. “Both processes lead to the destruction of neural tissue and loss of physical ability in patients.”
That is why the three main characteristics of Bidofuludimus Calcium are so important: anti-inflammatory, neuroprotective and antiviral properties.
First, there is an inflammatory process that specifically contributes to MS relapses.
“Our drug has a mechanism of action that targets a protein called DHODH, which is in a metabolic pathway, and it’s very good at preventing inflammation,” Vitt said.
Immunic’s Phase 2 study showed this worked to reduce inflammatory lesions in the brain as measured by MRI, and reduce relapses.
The second is a neuroprotective effect associated with activation of Nurr1, “which is known to play an important role in protecting neurons from cell death,” Vitt said. Parkinson’s diseaseClinical trials have shown that activating the receptor protects associated neurons from cell death and slows the progression of the disorder in patients.
“That’s a big differentiator. I’m not aware of any other MS drugs that act on Nurr1,” Vitt says, “so I think this drug will be very different from the current standard of care because it’s a Nurr1 activator.”
The third is the antiviral portion. Research suggests It has been shown that infection with the Epstein-Barr virus (EBV) makes a person 32 times more likely to develop MS.
“One of the causes of this disease is EBV infection,” Vitt said, “which is one of the major factors that causes patients to develop multiple sclerosis.”
“Bidofludimus calcium has strong anti-EBV activity and may suppress EBV-associated T cells. In clinical trials, the combination of these factors has helped patients live longer and more independently, slowing disease progression and avoiding disability — what is often most important to patients,” Vitt said.
easy to use
In addition to its clinical benefits, the safety profile of Bidofludimus calcium is another factor that establishes its status as a potentially game-changing drug in MS treatment.
“I think that’s one of the great strengths of this molecule,” Vitt said.
In over 1,800 subjects enrolled in clinical trials, the drug’s side effect profile was very similar to that of placebo, with no differences in liver enzymes observed between treatment and placebo groups, no cardiovascular findings, and no increased risk of infection.
This means it could be a simpler treatment for both patients and physicians, without the need for costly and cumbersome screening and monitoring — and it differs from many other MS treatments in development, such as Bruton’s tyrosine kinase (BTK) inhibitors. Liver problems.
“What I’ve learned from doctors is they want the easy fix,” Vitt said.
Vitt said the company plans to release data from its Phase 2 trial in progressive multiple sclerosis in April 2025, which will help determine how well the drug protects the brain, and that results from the Phase 3 trial are expected the following year.
Slowing the progression of the disorder is an important discussion point for patients and doctors, Vitt said.
“With multiple sclerosis, patients lose their independence over time,” he says. “That’s the biggest threat to patients today.”
