Tiziana completes enrolment of first patient cohort in MS expanded access programme

Tiziana Life Sciences (Tiziana) has completed the 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), following the start of enrolment announced last week.

MS is a potentially disabling disease of the central nervous system. Signs and symptoms vary widely. Some patients with severe MS may lose the ability to walk independently or at all, while others may experience long periods of remission without any new symptoms.

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.

Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana, said the company was “very encouraged” by the rapid enrolment.

He continued: “This is the first time that non-active SPMS patients may receive a higher, 100mcg dosing of intranasal foralumab versus the 50mcg dosing previously studied. This, combined with the imminent results expected in the coming months from PET scans from the first two patients with longer follow up data, should confirm the clinical benefits of intranasal foralumab in this patient population and support the start of phase 2 studies next year.”

The company announced positive results for intranasal foralumab in September this year, with the second patient with non-active SPMS showing ‘continued clinical improvement’ after six months of dosing.

Tiziana said 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.