A second patient with multiple sclerosis (MS) showed clinical improvements following intranasal foralumab treatment, according to a press release from Tiziana Life Sciences. 

The investigators reported that the treatment improved the gait stability and endurance of the patient who had nonactive secondary progressive MS (SPMS) and received a total of 10.5 treatment cycles of foralumab to date.

While they previously required a cane to walk 100 m, 6 months after the treatment the patient could walk the same distance without a cane, corresponding to a 0.5 point improvement in the Expanded Disability Status Scale (EDSS) score. Furthermore, the patient’s pyramidal score stayed stable and did not get worse over time.


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“I am pleased, but not surprised to see additional clinical improvement in the second patient. SPMS represents an advanced stage of multiple sclerosis with few treatment options and creates a severe burden on patients,” said Howard L. Weiner, MD, the chairman of Tiziana’s scientific advisory board.

“Patients with non-active SPMS normally do not improve over a six-month time course,” said Dr. Tanuja Chitnis, MD, the principal investigator of the clinical study. “I am very encouraged by these results and look forward to seeing this patient’s [positron emission tomography (PET)] imaging to determine if there is a continued reduction in microglial activation to correlate with the improvement we are observing in the patient’s clinical exam.”

The researchers intend to do the 6-month PET imaging in the 4th quarter of 2022 to confirm simultaneous improvements in microglial activation. The investigators also expect to enroll an additional 4 patients at Brigham and Women’s Hospital in Boston, Massachusetts, then.

Foralumab is an anti-CD3 antibody that reduces cytokine release. It has been shown to target the T-cell receptors modulating the immune response. Intranasal foralumab was also well-tolerated and led to clinical response in patients with COVID-19 at a dose of once a day for 10 consecutive days. 

MS is an autoimmune disease characterized by the immune system mistakenly attacking the myelin sheath covering the nerve cells. This leads to inflammation, demyelination, and axonal loss and causes symptoms such as fatigue, vision impairments, numbness and tingling, muscle weakness, mobility issues, pain, cognitive dysfunction, anxiety, depression, bladder problems, dysphagia, and dysarthria.

Reference

Tiziana Life Sciences announces continued clinical improvements in the second patient with secondary progressive multiple sclerosis (SPMS) after six months of dosing with intranasal foralumab. News release. Tiziana Life Sciences; September 20, 2022.