Tiziana completes last patient visit in Phase 2a INFORM-MS foralumab trial

Tiziana Life Sciences announced on September 21, 2026 that the last patient completed their final visit in the Phase 2a INFORM-MS trial testing intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis, according to the company's press release.

The randomized, double-blind, placebo-controlled study, registered as NCT06292923, enrolled 48 patients in three cohorts at several U.S. clinical sites.¹ It is testing two doses of intranasal foralumab against placebo over 12 weeks, with the main outcome measure being change in microglial activation assessed by PET imaging, alongside secondary measures using the Expanded Disability Status Scale and the Modified Fatigue Impact Scale.¹

Tiziana said it expects to lock the trial database within the week and to release 12-week topline data in October.¹ After the blinded portion ends, all participants, including those who received placebo, can enter a six-month open-label extension intended to collect longer-term safety and efficacy data.¹

The company pointed to its Expanded Access Program in na-SPMS, saying most treated patients either stabilized or improved over an extended period.¹ Separately, 14 na-SPMS patients dosed under the open-label Expanded Access Program, registered as NCT06802328, showed either improvement or disease stability within six months, according to the company.¹

Foralumab, described as a fully human anti-CD3 monoclonal antibody, is also being evaluated in additional Phase 2 trials in Alzheimer's disease and multiple system atrophy, beyond the na-SPMS program.¹ CEO Ivor Elrifi said the company looks forward to unblinding and presenting topline data the following month.