Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Tuesday that updated data from its Expanded Access Program showed intranasal foralumab continued to be well tolerated over extended treatment in patients with non-active secondary progressive multiple sclerosis (na-SPMS), with encouraging signs of disability stabilization and reduced fatigue.
The biotechnology company said data collected through March 2026, updated from an earlier March 2025 readout, covered 14 patients enrolled in the ongoing program evaluating foralumab, a fully human anti-CD3 monoclonal antibody administered intranasally.
On disability outcomes, the company said it observed a favorable trend toward disease stabilization as measured by the Expanded Disability Status Scale (EDSS), with the foralumab cohort showing only a single confirmed disability progression event when compared against reference arms from the Phase 3 HERCULES trial in non-relapsing SPMS.
Nine of the 14 participants, or 64%, achieved a clinically meaningful improvement of at least four points on the Modified Fatigue Impact Scale (MFIS), a threshold consistent with published criteria in the field.
Tiziana cautioned that given the small sample size, the results represent a trend analysis only.
Dr. Howard Weiner, director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital and chair of Tiziana's Scientific Advisory Board, said the longer-term results continued to support foralumab's potential as a novel immunomodulatory therapy, describing the tolerability profile and clinical trends as "highly encouraging."
CEO Ivor Elrifi said the company was looking to advance the program toward approval.
“Intranasal foralumab's unique mechanism, which reduces neuroinflammation, positions it as a potential new treatment paradigm for progressive forms of multiple sclerosis where treatment options remain limited,” Elrifi said. “We look forward to advancing this program to approval."
Shares of Tiziana added 4.5% on the update.