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 provided additional context on the positive topline results from its Phase 2a INFORM-MS trial, building on the Key Opinion Leader (KOL) investor call held on Monday, November 9, 2026.
The November 9 call, featuring principal investigator, Tanuja Chitnis, M.D., Tarun Singhal, MBBS, M.D., M.B.A., and Howard L. Weiner, M.D., reviewed the dual primary endpoint success of INFORM-MS with the investment and scientific communities.
Key points emphasized during the discussion included:
- INFORM-MS placebo-controlled 12-week findings confirmed longer-term real-world data trends seen in patients treated for up to 3 years in the foralumab expanded access (EA) program, where we have seen EDSS stabilization and improvement in patients with treatment-refractory na-SPMS progressing via PIRA.
- Statistically significant reduction in microglial activation on [¹⁸F]PBR06 TSPO PET imaging with the 50 μg dose versus placebo (p=0.0168)—the dose for which this arm was powered for statistical significance.
- The positive signals in the 50 μg dose (n=19) supporting a potential effect on the chronic neuroinflammation underlying progression independent of relapse activity (PIRA).
- 100 μg dose was exploratory to assess immunomodulatory effects as previous Phase 1 observations showed that higher doses (e.g., 250 μg) had less immunomodulatory effects relative to 50 μg. Fewer patients (n=11) were enrolled in this arm to meet study timelines.
- Favorable safety and tolerability profile of intranasal foralumab as the first non-invasive anti-CD3 therapy at both doses studied.
- Clinically meaningful and statistically significant improvements in Modified Fatigue Impact Scale (MFIS) scores from baseline in both dose arms after only 12 weeks (50 μg: –6.17 points, p=0.035; 100 μg: –7.18 points, p=0.040), an endpoint for which the study was not powered, yet which exceeded the threshold for clinical relevance.
These early signals closely mirror the biological and clinical effects previously observed in the Company’s open-label expanded access program. In the peer-reviewed paper, "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients With Nonactive Secondary Progressive Multiple Sclerosis" (Chitnis et al., Neurol Neuroimmunol Neuroinflamm 2026;13:e200543), ten patients with treatment-refractory na-SPMS, who continued to progress despite B-cell therapy, received nasal foralumab for a minimum of six months.
Key findings in the expanded access program included:
- All 10 patients stabilized on Expanded Disability Status Scale (EDSS) scores.
- Three of four patients treated continuously for 12 months demonstrated improvement on EDSS.
- Seven of ten patients showed improvement in fatigue on the MFIS scale after 6 months of foralumab treatment.
- No study drug related serious adverse events have been seen in more than 37.4 patient-years of cumulative exposure.
- Reduction in TSPO-PET signal over six months (p < 0.05), consistent with dampened microglial activation.
- Induction of regulatory immune responses, including increased TGFβ expression across multiple cell subsets.
- No anti-drug antibodies (ADAs) were detected in any serum samples evaluated from patients at multiple time points (baseline through 15–17 months for the longest-treated patients, and through 6 months for others).
Updated data from the ongoing intermediate-size EA program (now encompassing 14 patients, with some treated for up to three years) continues to show favorable tolerability over extended treatment durations, with trends toward disability stabilization and clinically meaningful fatigue improvements, further reinforcing the absence of immunogenicity concerns.