Tiziana Life Sciences has announced positive preclinical results for a combination therapy using nasal anti-CD3 antibody (foralumab) and semaglutide, a GLP-1 agonist, in models of diet-induced obesity (DIO). The study, conducted by researchers at Brigham and Women’s Hospital, demonstrated that the combination significantly improved liver homeostasis and reduced inflammation, suggesting a potential new approach to combat obesity-related complications.
Synergistic Effects on Liver Homeostasis
The research highlighted synergistic effects of nasal anti-CD3 and semaglutide in promoting liver health in preclinical DIO models. Mice treated with the combination showed livers that more closely resembled those of lean mice on a normal diet, compared to those treated with semaglutide alone, which still exhibited enlarged, fatty livers.
Reduction in Inflammation Markers
The combination therapy led to marked reductions in pro-inflammatory cytokines and significant improvements in liver markers associated with metabolic regulation. This dual benefit addresses both the metabolic and inflammatory aspects of obesity, offering a comprehensive therapeutic strategy.
Expert Commentary
"We are excited by the potential of this novel combination. Nasal foralumab’s ability to modulate immune response in humans has always been promising. Now, combining anti-CD3 with semaglutide resulted in additional benefit on liver homeostasis and reduced inflammation in this mouse model. This could pave the way for an entirely new approach in treating obesity-related metabolic disorders," said Dr. Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board.
Selma Boulenouar PhD, a leading researcher at Brigham and Women's Hospital, added, "The results of this study are very encouraging. Chronic inflammation is a hallmark of obesity and liver diseases. The combination of anti-CD3 with Semaglutide appears to mitigate this inflammatory response and restore normal liver function. These findings underscore the potential for combination therapies in addressing complex metabolic and inflammatory conditions."
Clinical Implications and Future Directions
Obesity is a growing global health concern, with associated metabolic disorders including insulin resistance, NAFLD, and chronic inflammation. The combination of nasal foralumab and semaglutide offers a novel therapeutic combination that addresses both the metabolic and inflammatory aspects of obesity.
Tiziana plans to advance these promising preclinical findings into further clinical development, with the goal of initiating in-human clinical trials in the future. This effort is aligned with the Company’s commitment to pioneering innovative solutions for inflammatory and metabolic diseases, leveraging the immunomodulatory properties of Foralumab.
About Foralumab
Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when dosed intranasally. It is currently being studied in a Phase 2a trial for non-active secondary progressive multiple sclerosis (na-SPMS).
