Treatments For Non-Active Secondary Progressive Multiple Sclerosis Remain Scarce – Tiziana Life Sciences' (NASDAQ: TLSA) First-In-Class Foralumab Is Showing Promise

Research is being done into whether there might be treatments that tackle Multiple Sclerosis (MS) through immunosuppression and a reduction of patient neuroinflammation. Anti-CD3 monoclonal antibodies are treatments that seek to reduce inflammation in the body, but all these immunosuppressive drugs use either animal or humanized antibodies, which are less effective than fully human antibodies. However, they have shown some results as immunosuppressants, and it was recently announced in March that Provention Bio PRVB is being acquired by Sanofi SNY for $2.9 billion for the company’s humanized anti-CD3 monoclonal antibody drug, teplizumab.  

Now London-based Tiziana Life Sciences TLSA is developing the first fully human anti-CD3 monoclonal antibody, foralumab. Tiziana is currently focusing its research on foralumab’s potential for treating late-stage MS, though the drug has the potential to treat multiple diseases.

Is Tiziana’s Treatment The Answer?

Foralumab targets the immune system by modulating the function of regulatory T-cells (Treg). Formulated as a nasal spray, foralumab is able to produce Treg cells which cross the blood-brain barrier and reduce inflammation in the brain. 

The exciting potential for this treatment was recently picked up in an article from the premier scientific journal, Proceedings of the National Academy of Sciences (PNAS). PNAS reported on a recent trial where the treatment reduced inflammation in patients with both COVID-19 and MS patients. 

Foralumab’s success was also picked up in a March article by Forbes that highlighted the unique potential for this immunomodulation therapy. As the only fully human anti-CD3 monoclonal antibody currently in clinical development, the drug is able to dampen inflammation in several immune cell subsets.

Initial Results Announced With Further Trials Planned in Q3 2023

The drug has already been tested on six non-active secondary progressive MS patients in an open-label expanded access (EA) program. The program evaluated patient progress on the expanded disability status scale (EDSS). The scale measures the severity of MS symptoms, with lower numbers representing less severe symptoms. While using ocrelizumab, the second expanded access patient (EA2) had deteriorated from a 3.5 to a 6.0 by October 2018. This EDSS score meant he couldn’t walk 200 meters without a cane, and ocrelizumab treatment was discontinued in 2021. 

However, after 11 months of using foralumab in 2022, EA2 had his EDSS score fall to 5.0. He recovered lost motor neuron control and was able to walk 200 meters without a cane. Positron emission tomography scans (PET scans) of the brain also revealed decreased neural damage across the brain. The company is excited by this development, especially in a late-stage, non-active SPMS patient, as no other drugs have been approved by the FDA for this condition. 

Encouraged by this result, Tiziana will begin its phase 2 trial in the third quarter of 2023. This will be a three-month, randomized, placebo-controlled trial, and its primary endpoint will be measured via PET scan. 

Want to learn more about Tiziana Life Science? Visit its website.

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