Tiziana Reports Positive Phase 2a Results for Intranasal Foralumab

Tiziana Life Sciences announced positive topline results on November 2, 2026, from its Phase 2a INFORM-MS trial (NCT06292923), evaluating intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in patients with non-active secondary progressive multiple sclerosis (na-SPMS). The trial met its dual primary endpoints, demonstrating a statistically significant reduction in microglial activation at the 50-µg dose and favorable safety and tolerability across both doses.

The findings provide placebo-controlled evidence of biological activity in a patient population with limited treatment options. However, the absence of a significant imaging effect at 100 µg and the lack of demonstrated between-group differences in fatigue outcomes leave important questions for further clinical development.

INFORM-MS Evaluated Two Intranasal Doses Over 12 Weeks

INFORM-MS was a randomized, double-blind, placebo-controlled Phase 2a study conducted across eight clinical sites in the United States. It enrolled 48 participants who were assigned to placebo (n=18), intranasal foralumab 50 µg (n=19) or 100 µg (n=11).

Treatment was administered over 12 weeks in four consecutive three-week cycles. The co-primary endpoints assessed safety and tolerability, and changes from baseline in microglial activation measured using [18F] PBR06 TSPO PET imaging. Secondary endpoints included the Modified Fatigue Impact Scale (MFIS) and Expanded Disability Status Scale (EDSS).

Primary Endpoint: Foralumab Reduced Microglial Activation at 50 µg

The principal efficacy-related finding was a statistically significant reduction in microglial activation in the 50-µg treatment group compared with placebo.

An analysis of 40 participants with evaluable PET scans showed an adjusted treatment difference of −0.0231 in globally normalized white-matter standardized uptake value ratio (SUVR), with a 95% confidence interval of −0.0416 to −0.0046 (p=0.0168). The finding remained statistically significant in a sensitivity analysis that excluded EDSS and timed 25-foot walk adjustments (p=0.0394).

However, the 100-µg group did not demonstrate a statistically significant difference from placebo. This divergence means the study does not establish a dose-response relationship or identify 50 µg as an optimal dose.

TSPO PET imaging provides a biomarker-based assessment of microglial activation, an important component of neuroinflammation. Although the observed reduction supports biological activity, it does not independently establish an improvement in neurological function or slower disability progression.

Secondary Endpoint: Fatigue Scores Improved, but Comparative Benefit Remains Uncertain

MFIS total scores decreased by 6.17 points in the 50-µg group and 7.18 points in the 100-µg group, compared with a 3.12-point reduction in the placebo group.

Both foralumab groups showed statistically significant improvements from their respective baseline scores (p=0.035 and p=0.040). Tiziana considers reductions exceeding four points clinically meaningful.

Nevertheless, these statistical comparisons were within treatment groups rather than between foralumab and placebo. The company did not report a statistically significant treatment-versus-placebo comparison for MFIS. The numerical improvement in the placebo group also warrants consideration.

The study was not powered to demonstrate definitive clinical outcome differences. EDSS scores remained unchanged across the three-month treatment period, which is insufficient to draw conclusions about longer-term disability progression.

Co-Primary Endpoint: Safety and Tolerability Supported Both Dose Levels

All 48 participants completed treatment, with no deaths, adverse-event-related discontinuations or study-drug-related serious adverse events.

Treatment-emergent adverse events occurred in 23 of 30 foralumab-treated participants (76.7%), compared with 15 of 18 placebo participants (83.3%). The most frequently reported events, occurring in at least 10% of patients in either foralumab group, included headache, falls, nasal congestion and rhinorrhea.

These findings support favorable short-term tolerability across both doses. However, the limited treatment duration and small study population do not establish long-term safety.

Earlier Expanded-Access Findings Provide Additional Context

Principal investigator Tanuja Chitnis, MD, of Harvard Medical School and Brigham and Women’s Hospital, said the PET imaging results closely mirrored reductions in microglial activation previously observed in the expanded-access programme, providing corroboration in a controlled setting.

Separately, Tiziana has reported that 14 patients with na-SPMS received foralumab through its open-label expanded-access programme (NCT06802328), with improvement or stability reported in all patients within six months. These observations provide additional clinical context but remain uncontrolled findings and should not be considered equivalent to randomized trial evidence.

Next Steps for Intranasal Foralumab

Tiziana plans to complete the full INFORM-MS dataset analysis, present detailed findings at an upcoming scientific congress and engage with the US Food and Drug Administration (FDA) regarding the potential path forward for further development in na-SPMS. The company has not provided a timeline for these activities.

Clinical Interpretation

INFORM-MS provides an encouraging imaging biomarker signal for intranasal foralumab, with the 50-µg dose demonstrating a statistically significant reduction in microglial activation compared with placebo. The favorable short-term safety findings across both doses further support continued investigation.

However, the absence of a significant imaging effect at 100 µg, the lack of demonstrated between-group superiority in fatigue outcomes and unchanged EDSS scores limit conclusions about clinical benefit. The findings support further evaluation of foralumab but do not establish that it slows disability progression or improves fatigue relative to placebo.

The next stage of development will need to determine whether the observed imaging signal translates into meaningful and sustained clinical outcomes in patients with non-active secondary progressive multiple sclerosis.

Reference

Tiziana Announces Positive Topline Results from Phase 2a INFORM-MS Trial of Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis, Tiziana LifeSciences, 02 November 2026

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients, ClinicalTrials.gov ID NCT06292923