Foralumab

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In 2024, significant advances in multiple sclerosis (MS) included the first approved biosimilar, revised McDonald Diagnostic Criteria, promising results from the ENHANCE and DAYBREAK trials, FDA approval of the SelfJect injector, and findings on foralumab and tolebrutinib. The DAAE score was developed for risk assessment, while simvastatin failed in the MS-STAT2 trial. Physician burnout in MS care was highlighted.

Tiziana Life Sciences announced dosing the first patient with intranasal foralumab for moderate Alzheimer’s disease, targeting brain inflammation. Foralumab, a fully human anti-CD3 monoclonal antibody, stimulates T regulatory cells to reduce neuroinflammation. This approach differs from beta amyloid or tau protein reduction strategies and represents a novel treatment avenue for Alzheimer’s disease.

Tiziana Life Sciences expands Phase 2 trial of foralumab nasal spray for nonactive SPMS, adding six sites in the U.S. Northeast. The trial aims to reduce microglial activity and inflammation, with preliminary data showing 80% reduction in microglial activity and 70% reduction in fatigue among patients. The FDA has granted fast track designation to foralumab for nonactive SPMS treatment.

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Tiziana Life Sciences expands Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS) with esteemed institutions in the Northeast U.S., aiming to address a significant unmet need in MS treatment.

Tiziana Life Sciences expands Phase 2 trial for intranasal foralumab in non-active SPMS to prestigious Northeast US centers, including Yale, Johns Hopkins, Cornell, Buffalo, UMass, and Thomas Jefferson, aiming to address unmet medical needs and centralize PET scans at Invicro.

The ALS Association awarded Tiziana Life Sciences a grant to fund a small, early-stage clinical trial testing foralumab nasal spray for ALS. The trial aims to investigate the safety and effectiveness of two foralumab doses in 20 ALS patients, building on positive findings from multiple sclerosis patients. The Hoffman ALS Clinical Trial Awards Program, funded by the ALS Association, supports early clinical trials to gather safety, dosing, and biomarker data, potentially attracting additional funding for further drug development.

Foralumab may help manage MS symptoms, especially in SPMS. Early signs include trouble walking, fatigue, and vision issues. MS diagnosis involves MRI scans, lumbar puncture, and evoked potential tests. Current treatments include medications, stem cell therapy, and physical therapy. Mass General Brigham is researching foralumab and advanced imaging for better MS care.

Recent Alzheimer’s and dementia research highlights include FDA approval of Alpha Cognition’s Zunveyl, failed phase 3 trials, legal issues for Cassava Sciences, and compassionate use of a new drug. CTAD conference data revealed anti-tau drugs' lack of efficacy, while Tiziana’s foralumab received FDA clearance for compassionate use. Eisai’s anti-tau drug E2814 showed potential in reducing biomarkers. Roche’s trontinemab and UCB’s beprenemab faced setbacks, and Athira’s Fosgonimeton failed in Phase 2/3. Gene therapy LX001 showed stabilization in amyloid levels and reduction in tau biomarkers. Symptomatic treatments like Zunveyl and Montelukast showed promise in managing memory symptoms.