By David Willey, Benzinga
Tiziana Life Sciences, Inc. (NASDAQ: TLSA) reports that its upcoming phase 2 trial for lead candidate foralumabs treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) has already been derisked, given the results from its expanded access program.
Developing innovative drugs can be a lengthy, risky process, as there are numerous unknowns that a company has to be prepared for. De-risking in drug development trials involves an early accumulation of as much information about the product as possible and can be an important strategy for companies to reduce unknown variables for future trials. De-risking can tell the company the drugs safety profile, how its mechanism of action works and what benchmarks to measure going forward. Tiziana has completed its expanded access program for foralumab, and the drug has already demonstrated a robust safety profile and improved the expanded disability status scale (EDSS) score in some patients.
Building A De-Risked Phase 2 Trial
Tiziana will start its phase 2a trial as a multi-center, double-blinded, placebo-controlled trial administering foralumab to its na-SPMS patients and it will use the results from its expanded access program as a primary outcome measure.
The company had taken 3-month Positron Emission Tomography (PET) brain scans for the six na-SPMS patients in its Expanded Access program. The chairman of Tiziana's Scientific Advisory Board described the results as extraordinary, with five of the six patients demonstrating reduced microglia activation, which suggests possible clinical improvements for the patients.
Foralumab works by targeting regulatory T-cells and crossing the blood-brain barrier to dampen neuroinflammation. Inflammation of the brain is caused by activated microglia the brains immune cells and drives the neural degeneration associated with MS. Foralumab can downregulate microglia activation, leading to potential improvements in the patient's disability status.
Foralumab is a first-in-class, fully human anti-CD3 monoclonal antibody (mAb), a class of immunotherapy drugs that target the patients immune system. Drugs using mAbs are increasingly common, and the global market for mAbs in 2022 was $210.06 billion. Companies looking to develop MS therapies include Sanofi (NASDAQ: SNY) and Bayer (OTC: BAYRY). However, there are currently no drugs approved by the Food and Drug Administration (FDA) for non-active SPMS.
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