Significant Improvements in Progressive Multiple Sclerosis Through Foralumab Treatment

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Over a 6-month treatment period, investigators observed either stabilization or improvement on outcomes of Expanded Disability Status Scale, MFIS, T25FW, and pyramidal score.

Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital

Tanuja Chitnis, MD

In a small-scale study of patients with non-active secondary progressive multiple sclerosis (SPMS), treatment with foralumab (Tiziana Life Sciences), an investigational anti-CD3 agent, resulted in improvements in clinical measures of fatigue and physical function.1,2

The data, presented at MSMilan 2023, the joint ECTRIMS-ACTRIMS meeting, held October 11-13, in Milan, Italy, included 6 patients with SPMS from an expanded access program, 4 of which were on therapy for at least 12 months and 2 who completed 6 months of treatment. Findings showed that all 6 patients experienced improvement in at least 1 clinical measure of Expanded Disability Status Scale (EDSS), pyramidal score, or Modified Fatigue Impact Score (MFIS), and all but 1 (5 of 6) showed improvement on microglial PET imaging at 6 months.

"I am pleased to see the continued clinical response to intranasal foralumab from patients enrolled in our expanded access na-SPMS program," principal investigator Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital, said in a statement.1 "Notably, in this latest clinical update for patients EA 3 through EA 6, we have seen improvement in the Modified Fatigue Impact Scale scores in three out of four patients, which is significant since fatigue is a major complaint in this population. We have also seen various degrees of improvement in the Expanded Disability Status Scale, Timed 25-Foot Walk Test, pyramidal function scores and NeuroQoL Fatigue scores in a disease state that typically shows a decline in function over time."

Patients entered the study with clinical progression despite disease-modifying therapies and were treated with nasal foralumab 50 ug/day 3 times a week for 2 weeks with 1 week rest, consulting a treatment cycle. Assessments were undertaken every 3 weeks, and standardized 3T MRI was performed at baseline, 3 months, and 6 months. Foralumab, a monoclonal antibody, is designed to bind to the T cell receptor and dampens inflammation by modulating T cell function, therby suppressing effector features in multiple immune cell subsets.

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Using 18F-PBR06-microglial PET imaging, findings showed that 5 of the 6 participants had reductions in PET signal at 3- and 6-months after initiating treatment. Notably, no new T2 or gadolinium-enhancing lesions were noted on post-treatment 3T MRIs. The therapy was shown to be safe and well tolerated with runny nose and nasal congestion, both self-limited, as the only treatment-related adverse events (AEs). Two patients had serious AEs deemed unrelated to the study drug (Patient EA1 and EA2 – COVID diagnosis; EA1 – 2 episodes UTI/cystitis associated with benign prostatic hyperplasia).

After treatment with foralumab, 4 patients showed stabilization of EDSS while 2 improved. On MFIS, 4 patients improved and 2 remained stable. Three treated patients demonstrated improvements in timed 25-foot walk test while 3 remained stable. Lastly, on pyramidal score, 2 patients improved and 4 remained stable.

"Intranasal foralumab is continuing to show clinical improvements over time in patients with na-SPMS where foralumab targets inflammation in the brain,” Gabriele Cerrone, acting chief executive officer and founder of Tiziana Life Sciences, said in a statement.1 "Based on the totality of the clinical results seen to-date, I am hopeful that intranasal foralumab and its anti-inflammatory mechanism of action could provide relief to patients with na-SPMS that currently have no available therapies."

Tiziana is still plannning to start a phase 2 study later this year assessing the efficacy and safety of foralumab among patients with SPMS. The trial’s protocol was designed with recommendations from the FDA following a positive type C meeting with the agency earlier this year. In addition to MS, the company has plans to assess the agent in Alzheimer disease, with an investigational new drug application submission expected to be filed by the third quarter of 2023 upon completion of toxicology studies.

REFERENCES
1. Tiziana Life Sciences announces positive 6-month clinical results in multiple sclerosis patients treated with intranasal foralumab. News release. October 16, 2023. Accessed October 17, 2023. https://www.tizianalifesciences.com/news-item?s=2023-10-16-tiziana-life-sciences-announces-positive-six-month-clinical-results-in-multiple-sclerosis-patients-treated-with-intranasal-foralumab
2. Chitnis T, Singhal T, Zurawski J, et al. Treatment of six non-active secondary progressive MS with nasal anti-CD3 monoclonal antibody (foralumab): safey, biomarker, and disability outcomes. Presented at: MSMilan; October 11-13, 2023; Milan, Italy. POSTER 281
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