Tiziana Life Sciences has reported data from a small clinical trial of a nasally administered antibody in COVID-19 patients. The study provided early evidence that the anti-CD3 human monoclonal antibody can improve outcomes in people infected with the pandemic coronavirus.
Antibodies are typically unsuited to nasal delivery. Tiziana identified foralumab as an exception after assessing its ability to act on systemic immunity via the epithelial lining of the nose, leading it to trial a nasal formulation in healthy volunteers before the pandemic hit. Armed with data from that study, Tiziana initiated a clinical trial in COVID-19 patients last year.
The study randomized 39 patients to receive either foralumab, foralumab plus dexamethasone or no treatment. Participants in the foralumab arms received the anti-CD3 antibody once a day for 12 days to assess its ability to counter inflammatory reactions to the coronavirus.
CT scans showed an 80% improvement in the lungs of subjects on foralumab, versus improvements of 75% in the combination cohort and 43% in the control group. The study was not powered for statistical significance.
Tiziana also looked at the effect of foralumab on IL-6 and C-reactive protein. Again, foralumab as a single agent was associated with the largest reductions, but a larger, powered assessment is needed to show whether the effect is statistically significant. Tiziana has some evidence that patients on foralumab recovered their sense of smell faster than their counterparts in the control group did.
The size of the study severely limits the conclusions that can be drawn from the data. However, the early signs of efficacy have offered encouragement to researchers linked to the development of the drug.
“Nasal administration of foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human infectious diseases with an overreactive immune systems, such as acute respiratory distress syndrome caused by COVID-19,” Brigham and Women's Hospital’s Howard Weiner, M.D., said in a statement. Weiner is chair of the scientific advisory committee at Tiziana.
Weiner thinks the approach may work in patients infected with the COVID-19 variants that threaten to limit the effectiveness of vaccines and anti-SARS-CoV-2 antibodies. The confidence reflects the fact foralumab is designed to modulate the immune system, rather than target the virus itself.