Tiziana Life Sciences Ltd (NASDAQ:TLSA) is set to highlight the design of its mid-stage trial for an experimental multiple sclerosis treatment at a leading international neurology conference this week.
The biotechnology company said it will present a poster at the 41st Congress of the European Committee for Treatment and Research of Multiple Sclerosis, or ECTRIMS, being held Sept. 24-26 in Barcelona.
The annual meeting is the world’s largest gathering focused on multiple sclerosis, drawing scientists, clinicians and drugmakers from around the globe.
The presentation will focus on the structure of a Phase 2a study of foralumab, Tiziana’s main drug candidate.
Foralumab is a fully human monoclonal antibody, a type of engineered protein designed to bind to specific targets in the immune system, that Tiziana is testing as a nasal spray.
The company points out that it is the first antibody of its kind to be delivered intranasally, an approach intended to fine-tune immune response while potentially avoiding some of the side effects linked to intravenous treatments.
The trial is enrolling patients with non-active secondary progressive multiple sclerosis, a stage of the disease in which symptoms worsen over time without new inflammatory flare-ups.
Treatment options for this form of MS are limited, and managing progression remains a major challenge.
“We are pleased to share the design of our Phase 2a trial of nasal foralumab with the MS research community at ECTRIMS,” said Ivor Elrifi, chief executive of Tiziana Life Sciences.
“This clinical trial represents an important step forward in our mission to develop innovative therapies for patients living with non-active secondary progressive multiple sclerosis, a population with limited treatment options.”
Tiziana noted that ten patients have already received foralumab under an expanded access program in the U.S., with either stability or signs of improvement observed within six months.
The ongoing Phase 2a trial is designed as a randomized, double-blind, placebo-controlled study, the gold standard for testing new drugs, and is exploring different dosing levels.
Based in Boston, Tiziana is developing therapies that use alternative delivery methods, such as intranasal sprays, to potentially improve safety and tolerability compared with standard intravenous approaches.