Foralumab stabilizes disability, eases fatigue in nonactive SPMS: Study
Developer Tiziana now testing nasal spray therapy against a placebo
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- Foralumab nasal spray stabilized disability and eased fatigue in nonactive SPMS patients.
- It also prevented new lesions and reduced nervous system inflammation.
- A placebo-controlled Phase 2a trial is underway to confirm these results.
Treatment with the nasal spray therapy foralumab stabilized disability over six months in all 10 people with nonactive secondary progressive multiple sclerosis (SPMS) who took part in an expanded access program, according to a peer review.
For those who received treatment for at least one year, the majority experienced a reduction in disability. Foralumab also eased fatigue and prevented the formation of new lesions.
Tiziana Life Sciences, the company developing foralumab, had previously announced these results last May. Now, the findings have undergone peer review — the process in which scientists rigorously examine the data for technical issues.
The full study, “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients With Nonactive Secondary Progressive Multiple Sclerosis,” was published in Neurology Neuroimmunology & Neuroinflammation.
“We are thrilled that these groundbreaking results have now been peer-reviewed and published, reinforcing our confidence in intranasal foralumab as a potential paradigm-shifting therapy for progressive MS and beyond,” Ivor Elrifi, Tiziana’s CEO, said in a company press release.
Because all patients in this small study received foralumab, the researchers noted that it was impossible to distinguish the effect of the treatment from a potential placebo effect. Tiziana is now running a Phase 2a trial (NCT06292923) that aims to test the therapy against a placebo in more than 50 people with nonactive SPMS. The Phase 2a study is recruiting participants at seven U.S. sites.
Nonactive SPMS treatments extremely limited
For most people with multiple sclerosis (MS), the disease is initially diagnosed as relapsing-remitting MS (RRMS), which is marked by periods of acute symptom worsening, or relapses, followed by periods of recovery.
Over time, RRMS can transition into SPMS, in which disability gets gradually worse over time, irrespective of relapse activity. Some SPMS patients will still experience relapses, and treatments for relapsing forms of MS may help control the disease in those individuals. But for patients with nonactive SPMS, who don’t experience relapses, available treatments are extremely limited.
Foralumab is an antibody-based therapy designed to reduce the inflammatory activity of immune cells that drive MS. It is administered as a nasal spray at a dose of 25 micrograms per nostril, three times weekly on a two-week-on, one-week-off schedule.
This open-label study was conducted as part of an expanded access program (NCT06802328), which provides access to experimental therapies outside clinical trials. A total of 10 participants with nonactive SPMS, most of whom had been experiencing disability worsening despite treatment, were treated with foralumab for at least six months.
During the study, participants’ disability was tracked using a standardized measure called the Expanded Disability Status Scale (EDSS), in which higher scores indicate worse disability.
After six months on foralumab, EDSS scores were unchanged for seven of the 10 patients. In the other three, EDSS scores were slightly reduced — indicating an easing of disability.
Of the four patients who were followed out to a year on foralumab, one had unchanged EDSS scores, and the other three had EDSS score reductions.
Other measures of walking ability, hand dexterity, cognition, and visual function generally showed consistent trends, with scores largely stable over six months of foralumab treatment.
Foralumab appeared to reduce nervous system inflammation
The researchers noted that six of the 10 patients reported clinically meaningful reductions in fatigue after six months on the experimental nasal therapy. Of the four who received treatment for one year, all experienced clinically meaningful reductions in fatigue.
“Clinically, we found that all patients stabilized in terms of their EDSS scores, and 3 of 4 patients treated for 12 months continuously demonstrated improvement on their EDSS. Six of 10 patients demonstrated an improvement in fatigue,” the researchers wrote.
Biomarker data from the study broadly indicated that foralumab treatment was reducing inflammation in the nervous system as intended. In particular, the therapy reduced the inflammatory activity of microglia, resident immune cells in the brain that are believed to contribute to worsening disability in nonactive SPMS.
This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab’s therapeutic potential in secondary progressive MS.
Safety data were also positive. One patient experienced tingling and numbness in the lips and tongue, which was deemed related to treatment, but no serious side effects with foralumab were documented.
“This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab’s therapeutic potential in secondary progressive MS,” said Tanuja Chitnis, MD, the trial’s principal investigator and senior neurologist at Brigham and Women’s Hospital. “The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets [central nervous system] inflammation … offering hope for patients with limited options.”
