Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial

Tiziana Life Sciences has reported positive topline results from the Phase IIa INFORM-MS study evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis.

The randomised, double-blind, placebo-controlled trial met its dual primary endpoints for reduction in microglial activation and safety and tolerability.

Patients receiving the 50 μg dose of intranasal foralumab showed a statistically significant reduction in microglial activation compared with placebo after 12 weeks of treatment.

Microglial activity was measured using [¹⁸F]PBR06 TSPO PET imaging, with the comparison between the 50 μg treatment group and placebo reaching a p value of 0.0168.

Both the 50 μg and 100 μg doses were also reported to be safe and well tolerated.

Foralumab is a fully human anti-CD3 monoclonal antibody being developed as an intranasal treatment for neurological diseases.

The study also assessed fatigue using the Modified Fatigue Impact Scale.

Patients receiving the 50 μg dose recorded an average 6.17-point reduction from baseline in MFIS score after 12 weeks, while those receiving the 100 μg dose had an average reduction of 7.18 points.

These changes were statistically significant compared with the respective treatment groups’ baseline scores, with p values of 0.035 and 0.040.

The placebo group recorded an average 3.12-point reduction.

Tiziana said reductions of more than four points in both active treatment groups were considered clinically meaningful.

However, the company did not report a statistically significant comparison between the foralumab groups and placebo for the fatigue endpoint.

No meaningful change was observed in Expanded Disability Status Scale scores during the three-month treatment period.

Tanuja Chitnis, MD, Principal Investigator of INFORM-MS and Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital, said the imaging findings were consistent with reductions in microglial activation previously observed in Tiziana’s expanded access programme.

She also highlighted the improvement in fatigue over the relatively short 12-week treatment period.

Non-active secondary progressive multiple sclerosis is characterised by gradual accumulation of disability without relapses.

Tiziana said there are currently no U.S. Food and Drug Administration-approved treatments specifically indicated for this form of multiple sclerosis.

INFORM-MS enrolled patients across eight clinical sites in the U.S.

Participants were randomised to receive placebo, intranasal foralumab 50 μg or intranasal foralumab 100 μg.

The study included 18 patients in the placebo group, 19 in the 50 μg group and 11 in the 100 μg group.

Treatment was administered over 12 weeks through four consecutive three-week dosing cycles.

Tiziana is also investigating intranasal foralumab in other neurological conditions, including Alzheimer’s disease, amyotrophic lateral sclerosis and multiple system atrophy.

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Related Topics and Keywords

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