Tiziana Life Sciences has published results from a pilot study of its intranasal Foralumab in mild to moderate COVID-19 demonstrating that nasal administration of the human anti-CD3 monoclonal antibody was well tolerated and significantly reduced lung inflammation in non-hospitalized patients. In 2019, the company announced positive Phase 1 results for the intranasal Foralumab as part of a program to develop the nasal spray for the treatment of neurodegenerative diseases.
The study, which was conducted with researchers from Harvard Medical School and Brazilian CRO Intrials, enrolled 39 patients who received either standard of care alone, standard of care plus 100 ug Foralumab and 6 mg oral dexamethasone, or standard of care plus 100 ug Foralumab daily over 10 days. Patients using Foralumab alone had a 69% reduction in IL-6 levels after 10 days compared to 37% for control and 41% for Foralumab plus dexamethasone. Foralumab alone demonstrated an 85% reduction in C-reactive protein compared to 41% for control and 55% for Foralumab/dexamethasone. Lung CTs showed increased reduction in infiltrates for significantly more patients in the Foralumab alone and Foralumab/dexamethasone groups compared to control.
Tiziana Life Sciences CEO and Chief Scientific Officer Kunwar Shailubhai said, “We are very pleased with the publication of the article in a peer-reviewed journal. The clinical findings reported in the article suggest that the nasal spray of Foralumab could be developed as a take home treatment, circumventing the obstacles associated with intravenous treatments for COVID-19 and its variants. We are looking forward to initiating shortly the next clinical study evaluating Foralumab nasal spray in hospitalized COVID-19 patients.”
Harvard Medical School Professor Howard Weiner commented, “Dr. Thais Moreira and other researchers at the Brigham and Women’s Hospital (BWH) have been engaged with the development of nasal spray of anti-CD3 monoclonal antibodies for treatment of neurodegenerative diseases. I am pleased our research has led to the development of this novel approach with Foralumab nasal spray for the treatment of COVID-19 patients. This technology is particularly important, because COVID-19 causes immune hyperactivity, and we believe nasal delivery of Foralumab could rapidly suppress inflammation both in the lung and systemically to provide immediate relief to COVID-19 patients.”
In June 2020, Tiziana announced that it was partnered with Sciarra Laboratories to develop a nebulizer for delivery of its TZLS-501 inhaled anti-IL-6 receptor monoclonal antibody for the treatment of COVID-19. According to the company’s web site, Tiziana intends to submit an IND for TZLS-501 in the 4th quarter of 2021.
Read the Tiziana Life Sciences press release.
