Biotechnology company Tiziana Life Sciences has begun dosing subjects in its placebo-controlled Phase II trial of foralumab, an intranasal fully human anti-cluster of differentiation 3 (CD3) monoclonal antibody.
The trial is being conducted at Yale MS Center in Connecticut, US, enrolling patients with non-active secondary progressive multiple sclerosis (na-SPMS).
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Subjects are currently being enrolled in the trial at Brigham and Women’s Hospital, Johns Hopkins and U Mass Medical Center.
The trial aims to evaluate the antibody’s tolerability, safety and impact on microglial activation in individuals with na-SPMS.
It will involve immunology, brain positron emission tomography (PET) imaging and clinical evidence measures that are recognised by the US Food and Drug Administration (FDA).
Tiziana Life Sciences’s chief development officer William Clementi said: “We are pleased to announce dosing at Yale in our multicentre Phase II trial, marking an important milestone in our efforts to address the unmet medical needs of patients with na-SPMS.
“This trial represents a significant milestone in our clinical development programme for intranasal foralumab and underscores our commitment to advancing innovative treatments and immune-based approaches for autoimmune diseases.”
The trial is expected to conclude by the end of the year, when all subjects will be given the option to join an open-label extension study for six months.
This phase will assess foralumab’s durable effectiveness, long-term safety and tolerability in a broader patient population.
Ten na-SPMS patients in the trial have so far received doses under an open-label, intermediate-sized Expanded Access Programme.
These subjects have all reportedly shown either improvement or stability in their condition over six months.
The FDA has authorised the inclusion of 20 extra subjects in the Expanded Access Programme.
Tiziana Life Sciences’ nasal delivery method is claimed to enhance efficacy, safety and tolerability when compared to intravenous delivery.
