TLSA: SPMS Update; Second Patient Gains Access

By John Vandermosten, CFA

NASDAQ:TLSA

READ THE FULL TLSA RESEARCH REPORT

First Patient Update from Intranasal Foralumab in SPMS, Second Patient Enrolled

On January 10, 2022, Tiziana Life Sciences (NASDAQ:TLSA) announced a progress update for its first patient in the evaluation of intranasal foralumab in secondary progressive multiple sclerosis (SPMS). The FDA also allowed for continued enrollment based on the favorable data from the first patient, and a second patient has been enrolled under the Individual Patient Expanded Access Program who will be treated at Brigham and Women’s Hospital (BWH) at Harvard University.

The first patient enrolled has completed 3 out of 6 months of dosing and the interim data show that intranasal foralumab was well-tolerated, as expected, and demonstrated favorable clinical response. The first patient continues to be treated and their six-month treatment period is expected to be completed by the end of March 2022. Tiziana reported that to date the patient has not shown signs of treatment intolerance or toxicities and appears to be responding well to treatment. The brain imaging data, as analyzed by PET, show reduction in microglial cell activation. In MS patients, destruction of myelin in the central nervous system is associated with activated microglia, a state which is thought to contribute to the disease.1,2

Previous studies have shown a positive correlation between increased microglial cell activation and their presence in the brain with cognitive disability, as evidenced by higher scores on the Expanded Disability Status Scale (EDSS). Tysabri (natalizumab) (NASDAQ:BIIB), an approved drug for treatment of MS, is also believed to act via reduction in microglial activation.

The three-month safety data from the first patient were submitted to the FDA to gain approval to treat an additional patient under the Individual Patient Expanded Access Investigational New Drug Application (IND). The FDA responded that a second SPMS patient would be allowed to be dosed with intranasal foralumab. The second patient is already enrolled and treatment is expected to begin in January 2022 with interim clinical data expected in April 2022. The treatment plan will remain the same and investigators will be monitoring safety, neurological, and PET data to evaluate microglial activation. Immunological and neurodegenerative markers will also be monitored.

Program Summary

The active SPMS trial is being conducted to determine safety and tolerability. Dosing is 50 mg (25 mg each nostril), three times per week for two weeks followed by a one week break. To assess clinical response, PET imaging will be conducted to assess microglial activation. Cognitive behavior and immuno-biomarker analysis will also be conducted. As per the trial protocol, if safety and tolerability are favorable at three months, dosing will resume for another three months and additional patients may be considered. Complete data is expected to be available in 2Q:22.

Summary

Tiziana updated investors on the clinical progress of its first patient in the evaluation of intranasal foralumab in SPMS. Preliminary observations from the first patient show that intranasal foralumab is well-tolerated and the first patient on the drug has demonstrated favorable clinical response. The FDA has allowed for continued enrollment based on this data and a second patient has been enrolled.

As Tiziana updates investors on its SPMS trial, our focus remains on the two Phase II trials in Crohn’s Disease and Multiple Sclerosis. These programs drive the majority of the value in our assessment and address unmet needs in important indications.

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1. Lassmann H, Brück W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007;17(2):210–218.

2. Prineas JW, Kwon EE, Cho ES, et al. Immunopathology of secondary-progressive multiple sclerosis. Ann Neurol. 2001;50(5):646–657.

3. Tiziana Corporate Presentation. November 2021

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