Foralumab nasal spray trial starts dosing patients at Weill Cornell
Phase 2a trial testing safety, efficacy at several locations
A multicenter Phase 2a clinical trial testing foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) has begun dosing patients at Weill Cornell Medicine Multiple Sclerosis Center in New York.
The Phase 2a study (NCT06292923) is assessing the safety and efficacy of Tiziana Life Sciences‘ therapy, and aims to enroll up to 54 participants. Dosing began in late 2023 at Brigham and Women’s Hospital in Boston.
The company announced last year that the trial was expanding to other U.S. sites, including Weill Cornell. Recruitment is ongoing for people with nonactive SPMS between the ages of 18 and 75. Weill Cornell joins existing sites at Yale University, Johns Hopkins University, Brigham and Women’s, and the University of Massachusetts, Tiziana said.
The addition of Weill Cornell “further strengthens our Phase 2 clinical trial, which aims to address the significant unmet medical need in MS treatment,” Ivor Elrifi, PhD, CEO of, the treatment developer, said in a company press release.
Foralumab is an antibody therapy designed to reduce inflammation in the brain and spinal cord. It binds to the CD3 receptor on T cells, key immune cells involved in the inflammatory attacks that drive MS and other neurodegenerative diseases. By doing so, it is thought to suppress pro-inflammatory T cells while enhancing regulatory T cells, which help control excessive immune responses.
A need for new treatments
In a Phase 1 trial, foralumab nasal spray was found to be generally safe and well tolerated in healthy individuals and to modulate the immune system towards a more anti-inflammatory profile.
This Phase 2a trial is testing the treatment in people with non-active SPMS, a type of the disease in which MS symptoms steadily worsen in the absence of relapses or new inflammatory lesions. Mitoxantrone is the only approved therapy for this form of MS.
Patients in the trial are randomly assigned to receive nasal foralumab at a dose of 50 or 100 micrograms per dose, or a placebo, in three-week cycles – three times a week for two weeks followed by a week of pause – for a total of four cycles, or about three months.
The study’s main goal is to assess the treatment’s safety and efficacy in reducing the activity of microglia, the brain’s resident immune cells that contribute to neuroinflammation and MS progression. Secondary goals include changes in standard measures of motor and cognitive disability, fatigue, and quality of life, as well as changes in inflammatory brain lesions and brain volume.
Following the completion of the placebo part of the trial, expected by the end of the year, all patients may enter an open-label extension study, in which all will receive foralumab for six months. The goal is to assess the treatment’s long-term safety and efficacy.
Tiziana is also conducting an expanded access program (NCT06802328) in which people with nonactive SPMS may have access to foralumab nasal spray outside clinical trials.
Data from the first 10 patients treated under this program demonstrated that most experienced a reduction in microglia activity, indicating lower inflammation, and reduced fatigue after six months. Patients also had either a stabilization in or reduction of MS-related disability.
Tiziana has also established a partnership with Renaissance Lakewood to optimize the current formulation of foralumab nasal spray and establish a plan to scale up its production.
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