Foralumab - (INFORM-MS)

Sept. 21, 2026: Tiziana Life Sciences (Nasdaq: TLSA) said the last patient completed the last visit in INFORM-MS (NCT06292923), a randomized, double-blind, placebo-controlled Phase 2a trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). The study enrolled 48 patients in three cohorts across U.S. sites and is testing two dose levels versus placebo over 12 weeks. The primary endpoint is change in microglial activation by PET imaging; secondary endpoints include EDSS and MFIS.

The company said it expects to lock the database this week and report 12-week topline data in October. After the blinded phase, all participants may enter a six-month open-label extension to generate longer-term safety and efficacy data.

Separately, Tiziana said 14 patients have been dosed in an open-label expanded access program in na-SPMS (NCT06802328), with disease improvement or stability seen within 6 months in all patients, according to the company. The release also notes additional Phase 2 trials of intranasal foralumab are ongoing in AD and MSA.