To make ALS a livable disease, we need new treatments that not only help manage symptoms but also slow or stop its progression.

“We’ve seen tremendous growth in the number of new therapies and treatment approaches emerging for ALS in recent years,” said Dr. Kuldip Dave, senior vice president of research at the ALS Association. “As scientists learn more about the biological changes that underly ALS, they are developing therapies that target these pathways.”

Although the exact underlying cause or causes of ALS aren’t fully known, inflammation is thought to play a key role in driving the disease. Inflammation is the body’s natural response to things like injuries, infections, or illnesses. As specialized immune cells are mobilized, they work to protect the body from harm; however, they also can cause significant damage if they respond too aggressively or remain active for too long, especially in the central nervous system.

Researchers at Tiziana Life Sciences, Brigham and Women’s Hospital, and Mass General Hospital are developing a nasal spray that helps reduce inflammation in the brain and spinal cord. This experimental therapy, called foralumab, has been shown to decrease neuroinflammation in a small group of people with multiple sclerosis and help stabilize their disease. Now, the researchers want to see if foralumab might also help people living with ALS.

With a $1 million grant awarded through our Hoffman ALS Clinical Trial Awards Program, Drs. William Clementi, Suma Babu, Howard Weiner, and James Berry will conduct the first clinical study testing foralumab for ALS. This phase 2a trial will enroll 20 people living with ALS and will investigate the safety and effectiveness of two different doses of foralumab over six months.

During the small, early-stage trial, the researchers also will use positron emission tomography (PET) scans to measure brain inflammation and see if foralumab can reduce the amount of harmful immune system activity in the participants.

“We will be using PET imaging to detect neuroinflammation in this study of patients with ALS. We hope to replicate the previous positive findings of the PET imaging approach that Tiziana has seen in studies of patients with multiple sclerosis in this new potential indication for intranasal foralumab,” Dr. Berry and Dr. Babu said in a press release.

Funding for this trial follows an earlier $500,000 investment we made in the preclinical testing of foralumab through our Lawrence and Isabel Barnett Drug Development Program. Foralumab is the ninth potential ALS therapy supported by this program to move forward into clinical trials.

“With this award, we are pleased to continue to advance the development of intranasal foralumab for ALS,” said Dr. Dave. “By funding programs like this throughout their early stages, we hope to accelerate the development of therapeutic candidates that can help make ALS a livable disease until we can cure it.”

More information about clinical trials can be found on our website HERE. 

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