Tiziana Life Sciences Reports Positive Results from Ozempic and Nasal Anti-CD3 Combo Study

In a recent announcement from New York on October 30, 2024, Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology firm focused on developing innovative immunomodulation therapies, shared promising results from their preclinical studies. The studies examined the effects of combining their lead candidate, intranasal foralumab, a fully human anti-CD3 monoclonal antibody, with semaglutide, a GLP-1 agonist marketed by Novo Nordisk under the brand names Ozempic and Wegovy. The findings revealed that this combination significantly improved liver homeostasis and reduced inflammation in models of diet-induced obesity (DIO), suggesting a novel therapeutic approach to addressing obesity-related inflammation and liver dysfunction.

The preclinical data highlighted that administering nasal anti-CD3 in conjunction with semaglutide yielded synergistic benefits, enhancing liver homeostasis and significantly reducing inflammation markers, which are critical in managing obesity-related metabolic disorders. Mice fed a high-fat diet and treated with the combination therapy showed liver characteristics more akin to those of healthy, lean mice, unlike counterparts treated with semaglutide alone.

Nasal foralumab operates by modulating immune responses, inducing regulatory-type T cells. Meanwhile, semaglutide is known for its efficacy in treating obesity and Type 2 diabetes, primarily by enhancing insulin sensitivity and promoting weight reduction. This study, conducted by Dr. Howard Weiner and Selma Boulenouar PhD, along with their team at Brigham and Women’s Hospital in Boston, demonstrated that the combination therapy not only improved liver markers but also significantly reduced pro-inflammatory cytokines. This dual action is particularly beneficial in managing obesity and preventing its associated inflammatory complications.

Dr. Howard L. Weiner, Chairman of Tiziana’s Scientific Advisory Board, expressed enthusiasm about these findings, highlighting the potential of the combination therapy to revolutionize treatment approaches for obesity-related metabolic disorders. He emphasized that nasal foralumab’s ability to modulate the immune response, combined with the metabolic benefits of semaglutide, presents a promising new treatment strategy.

Selma Boulenouar PhD, a key researcher in the study, noted the significance of these results, stating that chronic inflammation is a hallmark of obesity and liver diseases. The study's findings suggest that the combination therapy effectively mitigates inflammatory responses and restores normal liver function, underscoring the potential for combination therapies in tackling complex metabolic and inflammatory conditions.

Obesity remains a significant global health issue, with associated conditions like insulin resistance, non-alcoholic fatty liver disease (NAFLD), and chronic inflammation leading to increased morbidity and healthcare burdens. The combination of nasal foralumab and semaglutide offers a pioneering therapeutic approach that addresses both the metabolic and inflammatory aspects of obesity.

Ivor Elrifi, CEO of Tiziana Life Sciences, also expressed excitement about the study’s outcomes, noting that the combination therapy could represent a breakthrough in treating not only obesity but also its downstream metabolic complications. Elrifi thanked the research team for their comprehensive study and anticipated the full publication of these findings in a peer-reviewed journal.

Tiziana Life Sciences plans to advance these promising preclinical results into clinical development, aiming to initiate human trials in the future. This aligns with the company’s commitment to developing innovative solutions for inflammatory and metabolic diseases by leveraging the immunomodulatory properties of foralumab.

The study at Brigham and Women’s Hospital is part of Tiziana's broader development program for foralumab, which includes applications for other inflammatory and autoimmune conditions. The company remains dedicated to advancing scientific innovations to meet unmet medical needs across various therapeutic areas.

Foralumab, a fully human anti-CD3 monoclonal antibody, is currently being tested in multiple clinical settings, including a Phase 2a trial for non-active secondary progressive multiple sclerosis. This antibody works by modulating T cell function, thereby reducing inflammation, and has shown potential benefits in conditions such as COVID-19 and multiple sclerosis.

Tiziana Life Sciences continues to explore alternative immunotherapy delivery methods, including their innovative nasal approach, which may offer improved efficacy and safety profiles compared to traditional intravenous delivery. The company’s pipeline includes several patented and pending applications, reflecting their commitment to developing broad therapeutic solutions.