Long COVID complications are estimated to take a $2.6-trillion toll on the U.S. healthcare system. Fortunately, a potential new Long COVID therapy is in the pipeline. Biotech company Tiziana Life Sciences has announced plans to evaluate the intranasal spray foralumab in people with Long COVID during the third quarter of this year, pending favorable feedback from the U.S. Food and Drug Administration (FDA).*

How does foralumab work?

Foralumab is an “anti-CD3 monoclonal antibody” which was developed for inflammatory conditions and is not being repurposed for COVID-19. 

The National Institutes of Health explains that monoclonal antibodies are lab-engineered copies of human-made antibodies, found to be especially effective against the COVID-19 virus. In this case, the monoclonal antibody blocks the CD3 protein receptor on T-cells (a primary immune system cell), thereby regulating T-cell activity and decreasing lung inflammation. 

In turn, other immune cells promoting inflammation are also suppressed, including brain and spinal cord immune cells called microglia.

Foralumab and COVID-19

Foralumab’s anti-inflammatory effect was observed in study participants with COVID-19 and multiple sclerosis (MS), as well as in healthy controls.

Howard Weiner, M.D. is Tiziana’s Scientific Advisory Board chairman and the founder and director of Brigham and Women’s Hospital’s Brigham Multiple Sclerosis Center. In 2020, he and Thais Moreira, Ph.D., a neurological diseases scientist at Brigham and Women’s Hospital and a Tiziana consultant, conducted a small Brazilian pilot study of foralumab, in which 39 patients with mild-to-moderate COVID-19 were given foralumab in the form of nasal spray.

• Patients receiving 100 micrograms a day of foralumab showed less lung inflammation after 10 days than those who did not.
• Several genes were found to be involved in the anti-inflammatory process.
• Reduced inflammation was also seen in a patient with MS at Brigham and Women’s, and in healthy volunteers.

Weiner noted that foralumab “is the first nasal monoclonal antibody” and that “inflammation is a major cause of many diseases.” Said Moreira, “We discovered a way to shut down inflammation not only seen in COVID-19, but also in a patient with multiple sclerosis as well as in healthy patients. This is very exciting because not only does our study suggest that this new monoclonal antibody drug is safe and can modulate the immune system without major side effects, but it can also decrease inflammation in multiple realms, so it may be useful for treating other diseases.”

In 2021, Tiziana entered into an agreement with FHI Clinical to perform a phase II (2) proof-of-concept trial of foralumab in people hospitalized with severe COVID-19 and lung inflammation in Brazil.

Next steps in foralumab studies for Long COVID

Matthew Davis, Tiziana’s chief medical officer, said the company plans on a phase 2a clinical trial once they’ve received positive feedback from the FDA. He said use of PET scanning will allow them to determine whether three months of intranasal foralumab has decreased microglia activity in the brains of Long COVID patients.

“After refining our clinical protocols, we need to discuss this approach with the FDA, and plan to file an IND [investigational new drug application] in 4Q 2023.”

*Staff. (2023, April 14). Tiziana Life Sciences plans to assess intranasal foralumab for long Covid. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/news/tiziana-life-foralumab-long-covid