Tiziana Life Sciences Ltd (NASDAQ:TLSA) CEO Ivor Elrifi talked with Proactive about a series of important developments for the company, including the dosing of its first patient in an early Alzheimer's disease Phase 2 trial. Elrifi explained that the FDA has allowed Tiziana to include both drug-naive patients and those previously treated with anti-amyloid therapies such as Leqembi or donanemab.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Wednesday it has dosed the first patient in a Phase 2 clinical trial testing its intranasal drug candidate foralumab in patients with early Alzheimer's disease. The randomized, placebo-controlled study will evaluate foralumab as a standalone treatment and in combination with FDA-approved anti-amyloid drugs lecanemab (Leqembi) or donanemab in people with early or mild Alzheimer's, the company said.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has begun enrolling participants in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in early Alzheimer's disease, with the first patient expected to be dosed next week. The trial will study foralumab, a fully human anti-CD3 monoclonal antibody, as both a standalone therapy and in combination with the FDA-approved anti-amyloid drugs lecanemab or donanemab.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) said on Tuesday it plans to spin out its anti-IL-6 receptor antibody program, TZLS-501, into a separately listed public company. Tiziana said its decision follows rising industry interest in the IL-6 pathway, highlighted by Novartis' $1.4 billion acquisition of Tourmaline Bio and its IL-6 inhibitor pacibekitug.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted into the ALS MyMatch Program at the Sean M Healey & AMG Center for ALS at Mass General Brigham. The study, supported by a grant from the ALS Association, will be led by Principal Investigators Suma Babu and James Berry at Mass General Brigham.
Tiziana Life Sciences' Foralumab intranasal anti-CD3 targets the Treg–microglia axis. However, their intranasal delivery makes them unique and patient-friendly. Foralumab has a Phase 2 for SPMS, a Phase 2a for MSA, and a Phase 2 for AD and ALS is planned. Early data show microglial PET reductions and stability in expanded access. Its bull case hinges on biomarkers against neuroinflammation.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) said Tuesday it has been invited to present at a major biotechnology conference in Riyadh, underscoring Saudi Arabia's push to position itself as a global hub for life sciences research and investment. The Nasdaq-listed biotech will attend the Life Science Innovation Forum, a two-day event hosted Oct. 1–2 at the King Saud bin Abdulaziz University for Health Sciences Conference Center.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that the US Food & Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its Phase 2a clinical trial of intranasal foralumab in patients with Multiple System Atrophy (MSA). The Phase 2a study is a six-month, open-label clinical trial designed to evaluate the effects of intranasal foralumab on microglial activation, clinical outcomes, and safety in MSA patients.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) said that its experimental nasal treatment for Alzheimer's disease showed promising results in a patient, helping reduce brain inflammation and possibly aiding in the removal of harmful protein buildup linked to the disease. The company's lead drug, intranasal foralumab, is a fully human antibody designed to regulate the immune system.
Tiziana is developing foralumab, a fully human anti-CD3 monoclonal antibody, for non-active secondary progressive multiple sclerosis patients, with key data expected in 2026. A phase 2 trial of foralumab in early-stage Alzheimer's Disease is set to begin in 2025, targeting microglial activation and neuroinflammation. The global Alzheimer's Disease market is expected to reach $23.8 billion by 2031.
Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has initiated patient dosing at the Weill Cornell Medicine Multiple Sclerosis Center in New York City as part of its ongoing Phase 2 clinical trial of intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Weill Cornell marks the fifth site participating in the trial, joining Yale University, Johns Hopkins University, Brigham and Women's Hospital, and the University of Massachusetts.
Tiziana Life Sciences Ltd (NASDAQ:TLSA)' investigational therapy intranasal foralumab has been shown to significantly reduce neuroinflammation in a 78-year-old patient with moderate Alzheimer's disease (AD), a newly published study has shown. The study, published in the Journal of Clinical Nuclear Medicine, was led by Dr Tarun Singhal and Dr Howard Weiner of Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system.