Nasally Administered Drug Could Generate Nasal Mucosal Immunity Against SARS-CoV-2

Tiziana Life Sciences plc (London, UK) has initiated clinical trial with COVID-19 patients in Brazil with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody that could generate nasal mucosal immunity against SARS-CoV-2 in the respiratory tract and lungs.

Foralumab, the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS). Nasal administration of Foralumab is a revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) and amyotrophic lateral sclerosis (ALS). Extensive data from animal studies with intranasal delivery of anti-CD3 demonstrate that this route of administration induces anti-inflammatory and immunomodulatory effects. Since reduced or defective levels of T regulatory (Tregs) cells in the blood seem to be associated with the severity of COVID-19 and acute respiratory distress syndrome (ARDS), nasally administered Foralumab, by acting locally, could potentially suppress excessive cytokine storm and hyperinflammation in respiratory tract and lungs of COVID-19 patients.

Tiziana is now collaborating with the Harvard Medical School and Santa Casa de Misericórdia de Santos Hospital for conducting a clinical study to investigate nasally-administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients in Brazil. The clinical data from the trial is expected to available by the end of this year.

“Brazil has reported almost 5.5 million coronavius cases and 159,000 deaths and is considered a global epicenter of the outbreak,” said Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences. “Brazil is now experiencing almost 1000 deaths per day. Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs.”

“Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems,” said Dr. Howard Weiner, the Robert L. Kroc Professor of Neurology at the Harvard Medical School. “Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease.”

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