Tiziana (NASDAQ: TLSA) Continues The Fight Against Multiple Sclerosis, Will Announce 6-Month Results For Its Novel Treatment Soon

August 04, 2023 at 09:00 AM EDT

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By David Willey, Benzinga

Tiziana Life Sciences (NASDAQ: TLSA), a clinical-stage biotechnology company focused on developing immunotherapies, will soon announce the 6-month results for patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) receiving its novel intranasal treatment, foralumab.

The company is conducting an expanded access program, where patients with non active secondary progressive multiple sclerosis (Na-SPMS) received foralumab, and a Positron Emission Tomography (PET) brain scan was taken for each patient at the 3-month mark. Tiziana declared that the findings were “extraordinary,” as the trial saw reduced microglia activity in five of the six patients with na-SPMS. This result indicates reduced neuroinflammation for these five patients and the possibility of an improvement in their condition.

“To see a reduction in microglial activation in 5 out of 6 na-SPMS patients in only 3 months is extraordinary. This finding is even more remarkable because all of the 6 expanded access patients’ na-SPMS had clinically regressed on ocrelizumab treatment,” said Howard L. Weiner, M.D, chairman of Tiziana's Scientific Advisory Board. He continued, “I am excited to follow this program to see if the improvement in the 3-month PET scans will translate to clinical improvement in the coming months.”

Now Tiziana is approaching the 6-month mark for its patients in the program and will be publishing the results for these patients. The company will be hoping that the positive results it saw at the 3-month mark will be replicated. It also anticipates progressing clinical development for foralumab by starting a phase 2 trial in Q3 of 2023.

Foralumab Could Decrease NeuroInflammation

These results are expected even as a recent study linked MS to a greater risk of Alzheimer's and dementia. Tiziana is tackling MS, Alzheimer’s and other neuroinflammatory diseases with foralumab, which reduces neuroinflammation caused by microglia activated by amyloid plaque buildup.

By binding to regulatory T-cells, foralumab is able to cross the blood-brain barrier, decrease microglia activation and reduce neuroinflammation. Anti-CD3 monoclonal antibodies (mAb) are a class of therapy that reduces inflammation, and foralumab is the first fully human anti-CD3 mAb, which means it has a lower incidence rate and is less likely to cause an immune response than humanized or chimeric anti-CD3 mAbs.

The market has been paying particular attention to the potential of anti-CD3 mAbs since Sanofi (NASDAQ: SNY) acquired Provention Bio for almost $3 billion for Provention’s anti-CD3 mAb drug Teplizumab. Teplizumab is a humanized mAb, which suggests that there could be interest in Tiziana’s fully human mAb therapy.

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