Updated clinical data from an expanded access programme suggest that intranasal Foralumab may help stabilise disability progression and reduce fatigue in patients with non-active secondary progressive multiple sclerosis.
The findings were announced by Tiziana Life Sciences and are based on 14 patients receiving treatment through an ongoing expanded access programme. Researchers reported that the treatment continued to demonstrate a favourable safety profile over extended periods, with no new safety signals identified.
Investigators observed trends suggesting reduced disability progression, measured using the Expanded Disability Status Scale (EDSS), alongside clinically meaningful improvements in fatigue. According to the company, 64% of participants experienced at least a four-point improvement on the Modified Fatigue Impact Scale, a threshold regarded as clinically meaningful in previous research.
The analysis compared outcomes from the foralumab programme with reference data from the phase 3 HERCULES trial of tolebrutinib in non-relapsing secondary progressive multiple sclerosis. Company figures suggested lower rates of confirmed disability progression among patients receiving foralumab, although researchers acknowledged that the small sample size means the findings are not statistically significant and should be interpreted as trend data only.
Dr Howard L. Weiner, chair of the company’s scientific advisory board, said the results support further investigation of intranasal foralumab as a potential immunomodulatory treatment for progressive multiple sclerosis, where therapeutic options remain limited.
Foralumab is a fully human anti-CD3 monoclonal antibody designed to stimulate regulatory T cells when delivered intranasally. The treatment is also being evaluated in a phase 2a randomised, placebo-controlled study in patients with non-active secondary progressive multiple sclerosis.
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The company said the treatment’s nasal delivery approach may offer advantages in tolerability and convenience compared with intravenous administration. However, larger controlled studies will be required to determine whether the observed trends translate into clinically meaningful long-term benefits.
Progressive multiple sclerosis remains a major unmet need within neurology, particularly for patients with non-active disease who currently have limited approved treatment options.
This news item has been summarised using AI and checked by humans before publication.
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