Tiziana Life Sciences (Tiziana) has announced the start of enrolment of the first patient cohort in its intermediate size patient population expanded access programme to evaluate foralumab in non-active secondary progressive multiple sclerosis (SPMS) patients.
MS is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The condition affects around 700,000 people in Europe and approximately 2.5 million people worldwide.
SPMS is a stage of MS which comes after relapsing remitting MS for many people. With this type of MS, the patient’s disability gets steadily worse and relapses are unlikely.
The Massachusetts-based treatment programme will evaluate dosing at the ‘standard’ 50mcg dose and, if needed, a higher 100mcg dose of intranasal foralumab in two separate cohorts of four non-active SPMS patients each.
Dr Tanuja Chitnis, professor of neurology and senior neurologist in the Ann Romney Center for Neurologic Diseases, Brigham & Women’s Hospital – where the programme is being conducted – and a member of Tiziana’s Scientific Advisory Board, said: “We are looking forward to fully enrolling this important new treatment programme. It will be the first time that non-active SPMS patients may receive higher, 100mcg dosing of intranasal foralumab.
“To date, we have only studied 50mcg dosing in patients with non-active SPMS. Given the strong feedback we’ve received relative to evaluating foralumab in the non-active SPMS patient population, I am anticipating swift enrolment of our first patient cohort.”
In September, the company announced that the second patient with non-active SPMS showed ‘continued clinical improvement’ after six months of dosing with intranasal foralumab.
The company outlined that on 12 September 2022, the patient walked 100 metres without a cane or need for rest. Prior to this, on 8 June 2022, the patient required a cane to walk this same distance, corresponding with a clinically meaningful improvement in the Expanded Disability Status Scale (EDSS) score of 0.5.
Foralumab, the only entirely human anti-CD3 mAb, has also shown reduced release of cytokines after intravenous administration in healthy volunteers and in patients with Crohn’s disease.
In a humanised 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.