Tiziana Life Sciences completes Phase 2a intranasal foralumab MS trial enrollment

• Tiziana Life Sciences (NASDAQ:TLSA) reported completion of the final patient visit in its Phase 2a INFORM-MS trial evaluating intranasal foralumab in non-active secondary progressive multiple sclerosis.
• The randomized study enrolled 48 patients and is designed to assess effects on microglial activation and clinical measures.
• Topline 12-week results are expected in October 2026.

Tiziana Life Sciences (NASDAQ:TLSA) announced that the final patient has completed the final visit in its Phase 2a INFORM-MS clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

The randomized, double-blind, placebo-controlled study enrolled 48 patients across three treatment cohorts at multiple U.S. clinical sites.

The trial is evaluating two intranasal foralumab dose levels compared with placebo over a 12-week treatment period.

The primary endpoint focuses on changes in microglial activation measured through positron emission tomography (PET) imaging.

Secondary endpoints include clinical assessments such as the Expanded Disability Status Scale (EDSS) and Modified Fatigue Impact Scale (MFIS).

Tiziana said it plans to complete database locking during the week and expects to announce topline 12-week data in October 2026.

After completion of the blinded portion of the study, eligible participants may enter a six-month open-label extension in which all participants can receive intranasal foralumab to collect additional long-term safety and efficacy data.

Separately, Tiziana reported that its Expanded Access Program for na-SPMS has treated 14 patients, with the company reporting that all participants demonstrated disease stability or improvement within six months.