Tiziana says KOL call ties Phase 2a foralumab data to years of expanded access results

Tiziana Life Sciences held a Key Opinion Leader call on November 9, 2026 to provide further context on the Phase 2a INFORM-MS topline results it announced November 2, 2026 for intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). The company said the 12-week placebo-controlled findings from INFORM-MS confirmed trends seen in patients treated for up to 3 years in the foralumab expanded access program, including stabilization and improvement in EDSS scores among treatment-refractory na-SPMS patients progressing via PIRA.¹

The call reiterated that the 50 µg dose showed a statistically significant reduction in microglial activation on TSPO PET imaging versus placebo (p=0.0168), the dose for which this arm was powered for statistical significance.¹ Tiziana noted the 100 µg dose was exploratory, included to assess immunomodulatory effects after earlier Phase 1 data showed higher doses such as 250 µg had less immunomodulatory effect than 50 µg, with fewer patients (n=11) enrolled to meet study timelines.¹

On fatigue, the company said both dose arms showed improvements in Modified Fatigue Impact Scale scores from baseline after 12 weeks (50 µg: –6.17 points, p=0.035; 100 µg: –7.18 points, p=0.040), an endpoint the study was not powered for but which exceeded the threshold the company described as clinically relevant.¹

Tiziana pointed to its separate expanded access program, described in a peer-reviewed paper, in which ten patients with treatment-refractory na-SPMS who had continued to progress despite B-cell therapy received nasal foralumab for at least six months, and all ten stabilized on EDSS.¹ The company said no study-drug-related serious adverse events have occurred across more than 37.4 patient-years of cumulative exposure in that program.¹

CEO Ivor Elrifi said the company looks forward to completing full analysis of the INFORM-MS dataset and discussing next steps with the FDA.¹