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By Rachael Green, Benzinga

This month, Tiziana Life Sciences (NASDAQ: TLSA) expects to start enrolling patients for a phase 2a trial of Foralumab, an immunomodulation therapy for Secondary Progressive Multiple Sclerosis (SPMS) that’s administered through the nose. The news marks a major milestone on the path to bring the clinical-stage company’s lead drug candidate to market.

MS Patients Have Few Effective Treatment Options, And SPMS Patients Have Even Fewer

The incurable disease involves recurring painful flare-ups that can be so severe people lose the ability to walk or move. This happens when the immune system attacks parts of the body’s own central nervous system, damaging nerve fibers and interrupting communication between the brain and the rest of the body.

The oral medications that are available are generally immune-suppressing drugs that can reduce relapse rates. But because they are typically a blanket suppressant of the immune system, they also generally come with harmful side effects and increased risk of infection. Moreover, they aren’t always effective for patients with non-active secondary progressive MS (SPMS), the more severe and difficult-to-treat form of the disease that Tiziana is developing Foralumab for.

When a flare-up strikes, the current standard of care for MS generally involves either intravenous corticosteroids for reducing inflammation or blood plasma exchange – both of which need to be done in a hospital.

Positive 6-Month Clinical Results Give Hope That Foralumab Could Make A Difference In Patients’ Lives

Foralumab is an anti-CD3 monoclonal antibody. It binds to the CD3 receptor on the surface of T cells in the patient’s immune system. Rather than a blanket immune suppressor, this mechanism of action selectively dampens the autoimmune response — when the T cells attack the body’s own cells — without disrupting its ability to detect and fight external pathogens.

This has made it a promising candidate for fighting autoimmune diseases like MS as it has the potential to prevent painful autoimmune attacks without the severe side effects and risks that come with other immune-suppressing drugs.

Tiziana reports that Foralumab is the only anti-CD3 monoclonal antibody therapy currently in development that is fully human, meaning it's even less likely to trigger adverse reactions than the genetically engineered versions being developed by other pharmaceutical companies.

In October, the biopharma reported that five of the six patients who received the intranasal treatment in its expanded access program showed reduced microglia activation, a key biomarker of immune response and a possible contributing factor to the damaging flare-ups MS patients experience.

Positron Emission Tomography (PET) scans of the patients at three months and six months both found decreased microglia activity in the brain. That six-month clinical data also showed improvement across a number of other measures of the disease.

“Notably, in this latest clinical update for patients EA 3 through EA 6, we have seen improvement in the Modified Fatigue Impact Scale scores in three out of four patients, which is significant since fatigue is a major complaint in this population,” said Principal Investigator and Professor of Neurology at Harvard Medical School, Dr. Tanuja Chitnis, M.D.

“We have also seen various degrees of improvement in the Expanded Disability Status Scale, Timed 25-Foot Walk Test, pyramidal function scores and NeuroQoL Fatigue scores in a disease state that typically shows a decline in function over time.“

Building on that positive data, Tiziana is getting ready for a new phase 2a study of the intranasal treatment.

“I believe that the six-month qualitative na-SPMS PET readout by Dr. Singhal is very encouraging and will enable us to rapidly advance foralumab in Phase 2a testing to address patients afflicted with this devastating disease who currently have no FDA-approved treatments available,” said Tiziana Founder Gabriele Cerrone.

Patient enrollment for the new trial is expected to begin in December 2023.

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