Phase 1 Results Are "Extraordinary," Says Chairman Of Scientific Advisory Board As Biomedical Company Preps Phase 2 Trial For MS Treatment

Tiziana Life Sciences TSLA has presented data from its clinical trial showing that five of its six patients with an advanced stage of multiple sclerosis (MS) have shown a reduction in microglia activity, suggesting a possible improvement in their condition. 

Tiziana is a biotechnology company working on innovative immunomodulation therapies, and its lead drug candidate is the intranasally administered foralumab. 3-month Positron Emission Tomography (PET) scans for the patients in Tiziana’s Expanded Access (EA) program show microglia activity in the brain has been reduced. This suggests an improvement in neural inflammation in each of the patients.

All Tiziana’s EA patients are suffering from non-active Secondary Progressive Multiple Sclerosis (na-SPMS), an advanced, progressive form of MS. Currently, there is no Food and Drug Administration (FDA)-approved treatment for patients with na-SPMS.  

The chairman of Tiziana's Scientific Advisory Board, Howard L. Weiner, M.D reacted to the news, “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.” 

Looking ahead to the significance of these results, Weiner 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.”

Tiziana Prepares For Phase 2a

These results come as Tiziana prepares for its phase 2a trial, which will begin in Q3 of this year. The results also confirm what Tiziana saw in its first EA patients at the beginning of the year, and in these cases decreased microglia activity led to demonstrated clinical improvements.

Inflammation of the microglia, the immune cells in the brain, is an important component in driving the neurodegeneration associated with MS. By decreasing activation of the microglia, and consequently reducing neural inflammation, Tiziana hopes to see clinical improvements in its EA patients. The company also has an additional four patients in its EA program, and it is waiting for the results of its PET scans to see if it will replicate the results in its first six patients. 

Foralumab could prove to be a breakthrough for na-SPMS treatment, as improvement in these patients is rare and unexpected. This result could also impact other diseases where inflammation of microglia plays a role, like Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).

“I believe that Tiziana and Harvard are at the forefront of research in neuroinflammatory diseases with unmet need,” said Gabriele Cerrone, founder and acting CEO of Tiziana. “Our Phase 2a multi-center, double-blinded, placebo-controlled trial in na-SPMS uses the 3-month PET scan as the primary outcome measure and our Expanded Access data from the first 6 patients give us increasing conviction in the potential for a positive outcome. We believe this trial design will provide a quick validation of our intranasal foralumab asset and will allow the company to proceed to the next clinical phase of development in na-SPMS.”

Other companies involved in developing treatments for MS include Sanofi SNY and Bayer BAYRY.

Want to learn more about how Tiziana Life Science is tackling hard-to-treat diseases? Visit its website.

Featured photo by Matteo Vistocco on Unsplash.

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