Tiziana Life Sciences has announced promising results from an open-label study of its investigational multiple sclerosis (MS) therapy intranasal foralumab.
The trial has been evaluating the candidate in patients with non-active secondary progressive MS (na-SPMS), a stage of the neurodegenerative disease characterised by the steady progression of symptoms or disability.
Ten patients with na-SPMS who continued to experience disease progression despite treatment with B-cell therapy were treated with nasal foralumab for at least six months.
Results showed that all patients achieved stabilisation of their Expanded Disability Status Scale scores, and three of four patients who were treated continuously for 12 months showed improvement.
Fatigue improved in six out of the ten patients, as measured by the Modified Fatigue Impact Scale, and no new T2 lesions were observed on MRI.
TSPO-PET imaging also showed significant reductions in microglial activation at six months, while single-cell RNA sequencing demonstrated early and sustained changes in peripheral immune cells.
Approximately 2.9 million people worldwide are living with MS, a chronic immune-mediated disease of the central nervous system (CNS) that disrupts communication between the brain and the rest of the body.
Relapsing MS, marked by attacks of worsening neurologic function followed by partial or complete recovery periods, accounts for about 85% of diagnoses, while SPMS, which is not associated with relapses, is much less common.
Tiziana’s foralumab is a fully-human anti-CD3 monoclonal antibody that has been shown to stimulate T regulatory cells when dosed intranasally.
Nasal foralumab uses the body’s mucosal immune system to generate regulatory immune responses, which the company said provides a new mechanism to suppress CNS inflammation without the systemic immunosuppression observed with intravenous therapies.
Ivor Elrifi, Tiziana’s chief executive officer, said: “We are incredibly excited by these results, which validate the potential of nasal foralumab to fundamentally shift the treatment paradigm for progressive MS.
“We are also committed to advancing this promising therapy into other larger clinical studies, such as Alzheimer’s disease and amyotrophic lateral sclerosis (ALS) as quickly as possible.”
Tiziana has already initiated a placebo-controlled phase 2 trial to further evaluate nasal foralumab in a larger cohort of na-SPMS patients.