According to Tiziana Life Sciences, The ALS Association will award a Lawrence & Isabel Barnett Drug Development Program Grant to the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital (BWH) for a preclinical study of Tiziana’s intranasal foralumab anti-CD3 monoclonal antibody. The company said that researchers at BWH will evaluate the anti-CD3 mAb in an animal model of amyotrophic lateral sclerosis.
In September 2019, the company announced that a Phase 1 trial demonstrated that intranasal foralumab was well tolerated at doses of up to 250 µg per day. In August 2021, Tiziana announced positive results from a pilot study of intranasal foralumab in patients with mild-to-moderate COVID-19, noting that it significantly reduced lung inflammation.
Co-Director of the Ann Romney Center for Neurologic Diseases at BWH Howard L. Weiner, who chairs Tiziana’s Scientific Advisory Board, said, “This prestigious research grant will be used to further study the role of intranasal anti-CD3 mAb in dampening the microglial activation which amplifies ALS disease progression. This research follows our recently presented positive findings on intranasal anti-CD3 mAb in Alzheimer’s Disease preclinical models of neuroinflammation. Additionally, we are currently studying foralumab, the first entirely human anti-CD3 mAb, in patients with secondary progressive multiple sclerosis.“
Tiziana Executive Chairman and interim CEO Gabriele Cerrone commented, “Intranasal foralumab has demonstrated potential across multiple central nervous system (CNS) indications. We are encouraged by the preclinical research using an intranasal anti-CD3 mAb in the neuroinflammatory related diseases of ALS and Alzheimer’s, as well as the impressive clinical benefits we have already shown for foralumab in patients with multiple sclerosis. While our initial focus is on our ongoing MS program which will continue to generate clinical read-outs, we are excited by foralumab’s potential to help highly debilitated ALS patients with limited therapeutic options and high unmet need.”
Chief Medical Officer Matthew W. Davis added, “We have now seen the potential of intranasal foralumab to dampen microglial activation in three major neuroinflammatory-related diseases, which creates significant optionality for exploring its benefits in some of the most important and burdensome medical conditions of our time.”
Read the Tiziana Life Sciences press release.
