Tiziana Life Sciences Ltd (NASDAQ:TLSA) has hailed news of an improvement in a multiple sclerosis patient being treated with intranasal foralumab in a clinical study.
This second expanded access patient (EA2), who has non-active secondary progressive multiple sclerosis (SPMS), has shown further improvements since last reported in September last year, according to the US Food & Drug Administration (FDA) recognised Expanded Disability Status Scale (EDSS). This is a measure of neural network functioning with ratings from 1 to 10 - a higher score means more disability.
Before foralumab treatment, the patient's EDSS had worsened from 3.5 in 2018 to 6.0 in 2021 despite ocrelizumab therapy (now discontinued). In that year the patient needed a cane to walk 100 metres (m).
"In September 2022, 8 months after starting treatment with nasal foralumab, EA2 was able to walk 100 meters without a cane," noted biopharma Tiziana in a statement.
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"EDSS score improved from 6.0 to 5.5. EA2’s pyramidal score remained stable during this time. In December 2022, 11 months after starting treatment with intranasal foralumab, EA2 was able to walk 200 meters without a cane, resulting in an even greater improvement in EDSS; with EDSS falling from a score of 5.5 to 5.0. EA2’s pyramidal score continued to remain stable," the company added.
Dr Tanuja Chitnis, professor of neurology and the principal investigator of the clinical study commented: "The sustained improvement in EDSS score starting at 6 months and further improving after 11 months on foralumab treatment in patient EA2 is impressive and warrants further study in a Phase 2 trial."
Gabriele Cerrone, the executive chairman and interim CEO of Tiziana, added: "Six patients are currently enrolled and are being followed in our intranasal foralumab program. EA2’s clinical improvement justifies Tiziana’s decision to make intranasal foralumab for non-active SPMS our top priority."
And Dr Howard L. Weiner, co-director of the Ann Romney Center for Neurologic Diseases at BWH and chairman of Tiziana's Scientific Advisory Board, said: “SPMS represents an advanced stage of multiple sclerosis with few treatment options and creates a severe burden on patients. It is gratifying to see a 1.0 EDSS improvement in patient EA2 following treatment with intranasal foralumab.”
Foralumab (formerly NI-0401) is the only entirely human anti-CD3 mAb. In a humanized mouse model, it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
Contact the author at giles@proactiveinvestors.com