Tiziana Life Sciences is set to commence a Phase II trial of its nasal anti-CD3 human monoclonal antibody (mAb), Foralumab, in moderate to severe hospitalised Covid-19 patients in Brazil.
Due to Foralumab’s ability to affect systemic immunity through the epithelial lining of the nose, respiratory tract and gut, it is the first antibody that can be dosed nasally or orally.
Tiziana noted that Covid-19 enters through the nasal and respiratory passage. Foralumab’s proprietary nasal formulation and nasal delivery could facilitate immunity modulation, thereby delaying disease progression and could offer quick relief to Covid-19 patients.
This randomised, placebo-controlled study will act as a further proof of concept for nasal delivery of Foralumab and its safety and efficacy as a potent, systemic anti-inflammatory treatment for more severe Covid-19.
All trial participants in the study will be given standard of care background therapy along with Foralumab.
Tiziana Life Sciences chief medical officer Dr Neil Graham said: “We are excited about this next important step in our goal to validate our drug candidate and our novel delivery system as a promising and innovative approach to immunomodulatory therapy for Covid-19 and other mutant variants.
“By focusing on moderating the inflammatory consequences of the SARS CoV2 virus, we hope to have a therapy that has efficacy irrespective of local viral variants.”
The nasally administered anti-CD3 monoclonal antibody was found to lower pulmonary and systemic inflammation and was well tolerated in a recent clinical trial in mild to moderate Covid-19 patients.
In addition, recent studies indicate that the pathogenesis of pulmonary inflammation in Covid-19 comprises an irregular host response or overreaction of the immune system in patients.