• Numeric improvements were seen across key multiple sclerosis measures, including the Modified Fatigue Impact Scale, Expanded Disability Status Scale, Timed 25-Foot Walk test, Pyramidal Scores and NeuroQoL™ Fatigue scores.

• Data was presented at ECTRIMS (39^th Congress of the European Committee for Treatment and Research of Multiple Sclerosis) on October 11, 2023

NEW YORK, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced six-month data showing positive clinical improvements related to Modified Fatigue Impact Scale (MFIS) scores and similar important clinical measures of physical function in foralumab-treated, non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients participating in an Expanded Access (EA) Program.   This follows on from previously announced positive six-month PET scan data which was presented at ECTRIMS 2023.

The findings, which are summarized in table 1 below, show broad based six month improvements across various key measures for multiple sclerosis. Secondary progressive multiple sclerosis is hallmarked by an increase of disability over time. The table below shows a stabilization or an improvement in physical function of the various clinical measures over a six-month period.

Table 1

Fatigue, as measured above in MFIS, refers to an overwhelming sense of physical, mental, and emotional exhaustion that is disproportionate to the level of activity or effort exerted. It is a major, common, and often debilitating symptom experienced by many individuals with MS. It differs from the typical tiredness that everyone experiences from time to time. In the context of MS, it is called ‘primary fatigue’ and is a direct result of damage to the central nervous system. This kind of fatigue can significantly impact a person’s daily life and functioning.

“I am pleased to see the continued clinical response to intranasal foralumab from patients enrolled in our expanded access na-SPMS program,” stated Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School (HMS) and senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System. “Notably, in this latest clinical update for patients EA 3 through EA 6, we have seen improvement in the Modified Fatigue Impact Scale scores in three out of four patients, which is significant since fatigue is a major complaint in this population. We have also seen various degrees of improvement in the Expanded Disability Status Scale, Timed 25-Foot Walk Test, pyramidal function scores and NeuroQoL Fatigue scores in a disease state that typically shows a decline in function over time.