Trial of foralumab nasal spray for nonactive SPMS fills up

Patient enrollment is complete in a Phase 2a clinical trial testing Tiziana Life Sciences‘ foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS), a form of multiple sclerosis (MS) with limited treatment options.

“Reaching full enrollment in this landmark study is a testament to the strong belief in foralumab’s potential and the urgent need for effective therapies in secondary progressive MS,” Gabriele Cerrone, executive chairman and founder of Tiziana, said in a company press release.

The INFORM-MS study (NCT06292923) enrolled 48 adults across multiple U.S. sites who were randomly assigned to receive intranasal foralumab at one of two dose levels — 50 or 100 micrograms — or a placebo. Treatment is administered in three-week cycles: Participants use one spray in each nostril three times weekly for two weeks, followed by one week off treatment.

The placebo-controlled portion will last 12 weeks (about three months), after which participants may enroll in an open-label extension and receive foralumab for an additional six months.

The study’s main goals are to evaluate foralumab’s safety and determine whether the therapy can reduce the activity of microglia (a marker of neuroinflammation) using PET scans. Other measures include changes in cognition, motor disability measures, and fatigue, as well as MRI markers of disease activity, and brain volume.

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Top-line data expected later this year

“This completion of enrollment in our Phase 2a trial represents a pivotal moment for Tiziana Life Sciences and for patients suffering from [nonactive SPMS], a condition with limited treatment options,” said Ivor Elrifi, Tiziana’s CEO. “As the first placebo-controlled trial of intranasal foralumab, this study underscores our commitment to rigorously evaluating this innovative therapy’s potential to modulate the immune system and address neuroinflammation.”

Top-line data from the INFORM-MS trial are expected later this year and will be presented at the joint ACTRIMS-ECTRIMS meeting in Toronto in October. The results “could pave the way for a new treatment paradigm,” Elrifi said.

Foralumab is an antibody designed to target the CD3 receptor found on T-cells, immune cells that help drive the inflammation underlying MS. This is expected to suppress inflammatory T-cells while boosting the activity of regulatory T-cells, which help keep the immune system in check.

The therapy has also been shown to reduce microglial activity, which is believed to drive disease progression in nonactive SPMS.

Tiziana is running an expanded access program (NCT06802328) giving patients who are not in clinical trials access to foralumab.

PET scan data from the first 10 participants treated through the program showed that 80% experienced reductions in microglial activity after six months of treatment, suggesting lower levels of brain inflammation. In addition, 70% of patients reported reductions in fatigue, and all had stabilized or improved disability levels.

To date, the expanded access program has included 14 patients who have received intranasal foralumab for six months to 3.5 years. Long-term data showed that the treatment is safe and well tolerated, and results continue to suggest that it may ease fatigue levels. Of the 14 patients, nine had clinically meaningful improvements in fatigue levels, while two had clinically meaningful worsening.

Intranasal foralumab has received U.S. Food and Drug Administration (FDA)  fast-track designation for nonactive SPMS. The status is intended to accelerate the development and review of therapies with the potential to address unmet needs for serious conditions.