Tiziana 鼻喷 foralumab 治疗 na-SPMS 的 IIa 期 INFORM-MS 试验达到双主要终点

The Phase IIa INFORM-MS trial enrolled patients at eight US clinical centres.

Tiziana Life Sciences has reported that its Phase IIa INFORM-MS study of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) met its dual primary endpoints.

Foralumab is a fully human anti-CD3 monoclonal antibody and is Tiziana’s lead development candidate.

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The topline data from the randomised, double-blind, placebo-controlled study revealed a statistically significant reduction in neuroinflammation in the 50μg foralumab treatment arm compared with placebo. Both the 50μg and 100μg doses were found to be safe and well tolerated.

Na-SPMS is characterised by a gradual buildup of disability independent of relapses. There are no therapies currently approved by the US Food and Drug Administration (FDA) specifically for this form of the disease.

All 48 trial participants in the trial completed treatment. No deaths, discontinuations due to adverse events, or study-drug-related serious adverse events were reported.

Treatment-emergent adverse events were observed in 83.3% of patients who received placebo and 76.7% of foralumab-treated patients.

Tiziana Life Sciences CEO Ivor Elrifi said: “We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation.

“The statistically significant, and clinically significant improvements from baseline in MFIS at both 50μg and 100μg doses further strengthens our conviction in the potential of intranasal foralumab.”  

Headache, nasal congestion, fall and rhinorrhoea were the most common side effects that were reported in at least 10% of patients in either foralumab group.

The INFORM-MS trial enrolled patients at eight US clinical centres. They were randomised to receive placebo, intranasal foralumab 50μg, or intranasal foralumab 100μg.

Although the trial was not powered to demonstrate definitive changes in parameters such as fatigue, scores on the Modified Fatigue Impact Scale showed numerical improvements.