FDA Grants Permission to Enroll up to 8 Additional Secondary Progressive Multiple Sclerosis (SPMS) Patients in the Expanded Access Program with Intranasal Foralumab
- This Intermediate-Size Patient Population Expanded Access program will follow the same clinical dosing regimen as the two ongoing single-patient expanded access programs in SPMS patients.
- Tiziana recently reported clinical data from the first SPMS patient showing beneficial responses following six months of treatment with intranasal foralumab, a fully human anti-CD3 monoclonal antibody
- The clinical data update from the second SPMS patient is expected in
May 2022, representing 3 months of intranasal foralumab therapy.
The safety, tolerability, and clinical responses from the first two SPMS patients were submitted to the FDA to seek permission to treat up to an additional eight SPMS patients with the goal of obtaining more clinical data to assess robustness of the clinical responses. As part of the original treatment plan, the foralumab dose will remain 50 mcg three times a week (MWF), which is the same dose administered previously to the first two SPMS patients. The dosing regimen in this IND also has a provision for dose escalation up to 100 mcg three times a week (MWF) as an option to improve clinical benefit, if needed.
The treatment plan will be submitted to the
Excessive activation of microglial cells is well-known to be associated with neurodegenerative diseases such as multiple sclerosis (MS), Alzheimer’s disease and Parkinson1. The underlying causes of these diseases lead to microglial activation and brain inflammation2. Thus, inhibition of microglial activation is an important target for drug discovery and development for neurodegenerative diseases. Several FDA-approved drugs, such as TYSABRI® , MAYZENT® and ZEPOSIA® suppress microglial activation and exert neuroprotective effects in the central nervous system (CNS) in animal studies but longitudinal assessment of drug effects on microglial activation in SPMS patients remains to be determined. On
- Luo, C., et al., Neuropsychiatric Dis Treat. 2017; 13: 1661–1667.
- Alan, C-B., et al., Neuron 2018 Feb 21;97(4):742-768
- Tiziana Press Release March 10, 2022
Foralumab (TZLS-401; formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura et al., Clin. Immunol. 183:240-246, 2017). Once a day treatment for 10 consecutive days with intranasal foralumab was not only well tolerated but also produced strong clinical responses in COVID-19 patients (Moreira et al., Front Immunol 12: 709861,2021). Based on these studies, the intranasal and oral administration of foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
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Source: Tiziana Life Sciences Ltd.