In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.
Tiziana Life Sciences’ lead candidate significantly reduced a neuroinflammation biomarker in multiple sclerosis at one dose level but failed to beat placebo at a higher dose.
As of Monday’s market open, the biotech’s stock slid 17% to 67 cents per share.
Tiziana’s Phase 2a INFORM-MS trial is testing three-week cycles of foralumab, an anti-CD3 monoclonal antibody delivered intranasally, for patients with non-active secondary progressive multiple sclerosis (na-SPMS). Patients with this form of MS typically experience a gradual worsening of symptoms without relapse or new MRI activity. Patients experience progressive disability and fatigue; no FDA-approved treatments are specifically indicated for na-SPMS.
INFORM-MS met its dual primary endpoints—one safety and one efficacy measure—for 19 patients receiving the 50-µg dose but missed the efficacy endpoint at the 100-µg dose, according to a Monday news release.
At the lower dose, foralumab was tied to a statistically significant reduction in microglial activation at 12 weeks as compared to placebo. Microglia are thought to play a key role in inflammatory responses in MS.
No significant difference was recorded for the 11 patients receiving 100 µg of foralumab, however. Tiziana did not provide specific data behind the results, which were assessed using PET imaging to measure a mitochondrial protein biomarker.
On the safety side, the U.K.- and Boston-based biotech said that the two doses of intranasal foralumab were safe and well tolerated. The most common treatment-emergent adverse events were headache, fall, nasal congestion and runny nose.
On secondary measures, patients receiving foralumab showed improvements in fatigue compared with their own baseline scores, according to Tiziana, and no changes were recorded on a disability progression tracker.
“These results represent a significant milestone for patients with non-active secondary progressive MS, a population with significant unmet need and limited treatment options,” said Tanuja Chitnis, INFORM-MS principal investigator and neurology professor at Harvard Medical School/Brigham and Women’s Hospital, said in the Monday news release. “We consider these findings as encouraging evidence of the biological activity of nasal foralumab in this MS population where at present there are no approved treatments for these patients.”
Tiziana plans to present detailed findings from the trial at an upcoming scientific conference and meet with the FDA about a “potential path forward for further clinical development of intranasal foralumab in na-SPMS,” according to the release.
Foralumab is Tiziana’s lead candidate, with ongoing mid-phase testing of the asset in multiple system atrophy, Alzheimer’s disease and ALS. The investigational immunotherapy is also being assessed in an open-label extension program for na-SPMS.
The biotech’s only other publicly listed asset is an anti-IL-6 receptor monoclonal antibody called TZLS-501. In December 2025, on the back of increasing industry interest in IL-6, Tiziana said it would spin out TZLS-501 into a separate publicly traded company to boost the strategic focus of each company. Since then, there’s been no update on the planned spinout.
