- Trial met its dual primary endpoints for (1) statistically significant reduction (p=0.0168) in microglial activation as measured by TSPO PET imaging in patients treated with 50 ug nasal foralumab as compared to placebo and (2) safety/tolerability.
- Foralumab-treated subjects showed statistically significant and clinically significant improvements in Modified Fatigue Impact Scale (MFIS) scores compared with their own baseline scores after only 12 weeks of drug therapy. Subjects treated with 50 ug nasal foralumab saw a -6.17 point decrease from baseline (p=0.035), and those treated with 100 ug experienced a -7.18 decrease from baseline (p=0.040). No significant change was seen in the placebo group.
BOSTON, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, today announced positive topline data in its Phase 2a INFORM-MS trial with intranasal foralumab (a human, anti-CD3 monoclonal antibody) in patients with non-active secondary progressive multiple sclerosis (na-SPMS).
Non-active secondary progressive MS is a form of the disease characterized by gradual accumulation of disability independent of relapses. There are currently no FDA-approved therapies specifically indicated for na-SPMS, leaving patients with a significant unmet need, particularly related to progressive disability and fatigue.
The randomized, double-blind, placebo-controlled trial met its dual primary endpoints. Firstly, there was a statistically significant reduction in neuroinflammation (as measured by a reduction in microglial activation with[¹⁸F]PBR06 TSPO PET imaging), (p=0.0168) after 12 weeks of treatment between the 50 ug nasal foralumab treatment arm and placebo. Second, both 50 μg and 100 μg doses of intranasal foralumab were safe and well-tolerated.
The average fatigue scores improved by more than 4 points in both the 50 μg and 100 μg treatment arms, between baseline and Week 12, representing a clinically significant (Rooney et al., 2019) reduction of fatigue as measured by the Modified Fatigue Impact Scale (MFIS). The MFIS Total Score showed a numerical mean change of –6.17 in the 50 μg arm, –7.18 in the 100 μg arm compared with –3.12 in the placebo arm, representing a clinically significant improvement of more than 4 points within the treatment arms. These reductions were statistically significant compared with each treatment group’s own baseline scores [50 μg dose arm (p=0.035) and 100 μg dose arm (p=0.040)]. We did not see any changes in the EDSS secondary endpoint over the 3-month treatment duration.