Tiziana Life Sciences has announced the commencement of dosing in the fourth clinical site of the company’s Phase II trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS), at the University of Massachusetts (UMass), US.
UMass has joined Yale Multiple Sclerosis Center, Johns Hopkins University (JHU) Autoimmunity Center of Excellence, and Brigham and Women’s Hospital (BWH) in administering doses to subjects.
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The placebo-controlled, blinded study is set to conclude by the end of this year.
Post the blinded phase, all subjects, including those who were given a placebo initially, will be offered this intranasal therapy in a six-month open-label extension (OLE) phase.
The OLE is crucial for evaluating the long-term safety of the therapy in this patient cohort.
Currently, ten na-SPMS subjects have been dosed under an intermediate-sized, open-label Expanded Access (EA) Program.
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By GlobalDataWithin six months, all subjects demonstrated either stability or improvement in their disease.
Tiziana Life Sciences CEO Ivor Elrifi said: “The initiation of dosing at UMass marks another significant step forward in our mission to bring foralumab to patients living with non-active SPMS.
“We are grateful for the dedication of our investigators and research teams across all sites, as well as the patients who are participating in this trial. We look forward to the completion of the study and the insights it will provide into the potential benefits of foralumab.”
According to the company, foralumab is the first fully human anti-cluster of differentiation 3 (CD3) monoclonal antibody tailored for intranasal delivery.
The non-systemic approach claims to stimulate regulatory T cells to promote immune tolerance while reducing systemic immune suppression.
Moreover, the therapy is being assessed in a randomised, placebo-controlled, dose-ranging, multicentre, Phase IIa study for patients with na-SPMS.
The non-active SPMS intranasal foralumab Phase II trial commenced subject screening in 2023.
