Tiziana Life Sciences Ltd (NASDAQ:TLSA) said Tuesday that its experimental multiple sclerosis therapy, nasal foralumab, showed positive results in an early-stage study, with patients experiencing stabilised disease progression and reduced signs of brain inflammation.
The open-label study followed 10 patients with non-active secondary progressive multiple sclerosis, or na-SPMS, a difficult-to-treat form of the disease in which disability worsens even in the absence of relapses. All participants had previously progressed despite B-cell therapy.
According to the company, treatment with intranasal foralumab over six months led to stabilization in all patients, with no new MRI lesions and no serious adverse events.
Among the four patients who continued for a full year, three showed improvement on the expanded disability status scale, the standard measure of MS progression.
Tiziana also reported that six of 10 patients experienced improvements in fatigue, one of the most persistent and quality-of-life-limiting symptoms in progressive MS. Fatigue scores strongly correlated with brain inflammation markers on imaging.
Brain scans using TSPO-PET, a technique for detecting microglial activation, a hallmark of central nervous system inflammation, showed statistically significant reductions at six months.
Single-cell RNA sequencing revealed increased levels of regulatory T cells and anti-inflammatory signals, supporting the drug’s proposed mechanism of action.
The study marks a "significant advancement" for patients with non-active progressive MS, who currently face very limited treatment options, said Dr. Tanuja Chitnis, the study’s principal investigator and a professor of neurology at Harvard Medical School.
"Nasal administration of foralumab represents a novel, non-invasive approach that not only induces regulatory immunity but also reduces harmful CNS inflammation," she added.
Tiziana describes nasal foralumab as the only fully human anti-CD3 monoclonal antibody administered intranasally.
The therapy is designed to trigger immune tolerance through the nasal mucosa rather than suppressing the immune system systemically, as many existing MS drugs do.
The company has launched a Phase 2 double-blind, placebo-controlled trial to evaluate the treatment in a larger cohort of patients. Top-line data are expected by the end of 2025.
Chief Executive Ivor Elrifi said the company plans to explore the use of nasal foralumab in other neuroinflammatory conditions, including Alzheimer’s disease and ALS.
Shares of Tiziana surged over 20% in Tuesday morning trading.