Long-term treatment with intranasal foralumab has continued to show a favourable safety and tolerability profile in people with nonactive secondary progressive multiple sclerosis, according to a recent safety update submitted to the US Food and Drug Administration.
The findings were reported by Tiziana Life Sciences in its seventh annual Development Safety Update Report, which covered cumulative exposure to foralumab across clinical and expanded access programmes. The report included data from 37.4 patient-years of exposure, with no serious adverse events considered related to the study drug.
Most of the long-term safety data came from an open-label expanded access programme involving 14 patients with nonactive secondary progressive multiple sclerosis. Participants received foralumab nasal spray for periods ranging from approximately six months to 3.5 years. According to the company, patients remained clinically stable or showed improvement within six months of starting treatment, and no drug-related serious side effects were observed during follow-up.
Foralumab is a monoclonal antibody that targets the CD3 receptor on immune T-cells. Delivered intranasally, it is designed to activate regulatory T-cells that suppress abnormal immune responses while reducing the activity of pro-inflammatory T-cells implicated in multiple sclerosis. Preclinical and early clinical findings also suggest that foralumab may reduce microglial activation in the brain, a process thought to contribute to disease progression in nonactive secondary progressive multiple sclerosis.
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In addition to the expanded access data, the safety report included exposure from an ongoing phase 2a clinical trial evaluating foralumab in up to 54 adults with nonactive secondary progressive multiple sclerosis. Participants are randomised to receive one of two dose levels of intranasal foralumab or placebo for around three months, followed by an optional open-label extension. This trial is expected to report results in 2026.
The safety update also included limited exposure in other neuroinflammatory conditions, including one patient with moderate Alzheimer’s disease treated under an expanded access programme. Across all indications studied, no new safety signals were identified, and no protocol modifications were deemed necessary.
The continued absence of drug-related serious adverse events supports further clinical development of intranasal foralumab as a potential therapeutic option for progressive multiple sclerosis.
This news item has been summarised using AI and checked by humans before publication.
Sources
Multiple Sclerosis News Today
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