Tiziana Life Sciences LTD filed a Form 6-K on November 2, 2026, announcing positive topline results from its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis.

Key Highlights

  • Dual primary endpoints met: The trial met endpoints for both statistically significant reduction in microglial activation and safety/tolerability, according to the filing.
  • Microglial activation reduction: Patients treated with 50 ug nasal foralumab showed a statistically significant reduction (p=0.0168) in microglial activation as measured by TSPO PET imaging compared to placebo.
  • Fatigue scores improved at 50 ug dose: Subjects treated with 50 ug nasal foralumab experienced a -6.17 point decrease from baseline in Modified Fatigue Impact Scale (MFIS) scores (p=0.035) after 12 weeks.
  • Fatigue scores improved at 100 ug dose: Subjects treated with 100 ug nasal foralumab experienced a -7.18 point decrease from baseline in MFIS scores (p=0.040) after 12 weeks.
  • Placebo group showed no significant change in MFIS scores, according to the filing.

INFORM-MS Phase 2a Results: Microglial Activation and Fatigue Outcomes in Secondary Progressive MS

Tiziana Life Sciences LTD (NASDAQ:TLSA) disclosed via a Form 6-K filed November 2, 2026, that its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis met its dual primary endpoints. According to the filing, the two primary endpoints were: (1) a statistically significant reduction in microglial activation as measured by TSPO PET imaging in patients treated with 50 ug nasal foralumab compared to placebo, and (2) safety and tolerability.

The filing reported that the 50 ug foralumab group achieved a p-value of 0.0168 on the microglial activation endpoint. On the Modified Fatigue Impact Scale, the company disclosed that foralumab-treated subjects showed "statistically significant and clinically significant improvements" compared with their own baseline scores after only 12 weeks of drug therapy. Subjects in the 50 ug group saw a -6.17 point decrease from baseline (p=0.035), while subjects in the 100 ug group saw a -7.18 point decrease from baseline (p=0.040). The filing noted that no significant change was observed in the placebo group.

The filing was signed by Keeren Shah, Chief Financial Officer of Tiziana Life Sciences LTD, on November 2, 2026. The company noted that the information contained in Exhibit 99.1, which includes the full press release, is furnished and "shall not be deemed 'filed' for the purposes of Section 18 of the Securities Exchange Act of 1934." The filing is incorporated by reference into the company's Registration Statement on Form F-3 (Reg. No. 333-286064).

What Was Disclosed

Tiziana Life Sciences LTD furnished a Form 6-K on November 2, 2026, reporting that its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis met dual primary endpoints, including statistically significant reductions in microglial activation and favorable safety and tolerability outcomes.