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 characterized 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 stabilization 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.
In another development, a study published on May 8, 2025, evaluates the safety and feasibility of placenta-derived mesenchymal stem cells (PLMSCs) in five participants with secondary-progressive multiple sclerosis (SPMS). The primary outcomes focused on safety and tolerability, assessed through adverse event monitoring over six months.
Results demonstrated sustained improvements in clinical outcomes, as indicated by significant reductions in EDSS scores (P < 0.0001), cognitive and psychological assessments, and radial diffusivity (RD) indices (P = 0.0186) in DTI metrics over six months. fMRI analysis showed significant enhancements in brain connectivity and cognitive function. Immunologically, CD20/CD19 B cell markers decreased significantly (P = 0.0077), and anti-inflammatory cytokine IL-10 increased alongside reductions in pro-inflammatory TNFα, IL-6, and IL-17 (P < 0.0001) three months post-therapy.
Each patient received 3 × 106 cells/kg through IV injection. The six-month follow-up was chosen based on the timing of subsequent RTX administration. Patients were recruited from July 25, 2021, to July 2, 2022. The study highlights the potential of PLMSCs to improve clinical outcomes in SPMS patients, warranting further investigation.
Meanwhile, a separate study published on April 11, 2025, in Neurodegenerative Disease Management found that for female patients with MS, transcutaneous posterior tibial nerve stimulation (TPTNS) and repetitive transcranial magnetic stimulation (rTMS) are comparable for neurogenic overactive bladder symptoms. Sixteen female patients with MS and neurogenic overactive bladder were randomly assigned to receive TPTNS or rTMS for a pilot study, with treatments applied for a total of 10 sessions over two consecutive weeks.
Researchers observed no significant change within and between the TPTNS and rTMS groups in urodynamic parameters. However, significant improvement was seen in nocturia frequency in the TPTNS group compared with the rTMS group based on an analysis of parameters from a three-day voiding diary. There were no significant between-group changes seen in Overactive Bladder Questionnaire-V8, Incontinence Severity Index, or Incontinence Quality of Life Scale parameters.
The authors concluded, “The TPTNS and rTMS methods we employed for the treatment of neurogenic overactive bladder are advantageous in that they have no side effects and are easy to apply, and they are suitable treatment options for female patients with MS.”
As research continues to advance in the field of MS treatment, these studies offer hope for improved therapies and management strategies for patients suffering from this challenging condition.
