Tiziana Life Sciences Ltd (NASDAQ:TLSA) shares added almost 55% in pre-market trading on Tuesday after the biotechnology company announced that its Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease has been approved by the United States Food and Drug Administration (FDA).
The company said foralumab is a “potentially groundbreaking” treatment for Alzheimer’s because it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) will commence Phase 2 trials using foralumab, which it highlighted is the world’s only fully human intranasal anti-CD3 monoclonal antibody, which will be overseen by Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System.
"The IND clearance is a significant milestone for Tiziana that highlights the strength and the therapeutic potential of foralumab,” the company’s acting CEO Gabriele Cerrone said in a statement.
“We are thrilled to have reached this critical juncture and are eager to move forward with the necessary trials to evaluate the effectiveness of foralumab in Alzheimer’s disease in combination with an FDA-approved therapy or as a single agent.”
Investors welcomed the news, sending the company’s shares 54.6% higher to US$0.95 before the opening bell in New York.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
Its lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie