foralumab nasal (TZLS-401 nasal) / Tiziana Life Sci, Light Chain Biosci - LARVOL DELTA

Tiziana Life Sciences…announces that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s clinical trial and plans to dose the first patient next week (GlobeNewswire) - "The Phase 2 study is designed to evaluate the safety, tolerability, and efficacy of intranasal foralumab as both a monotherapy and in combination with lecanemab or donanemab in early/mild AD. Key endpoints will include measures of neuroinflammation (via TSPO-PET imaging), cognitive function, and biomarker changes related to amyloid and tau pathology."

Trial status • Alzheimer's Disease

Tiziana Life Sciences Nasal Foralumab Phase 2 Clinical Trial Accepted into Healey ALS MyMatch Program (GlobeNewswire) - "The trial will enroll at multiple rapid-enrolling U.S. centers within the Network of Excellence for ALS (NEALS) Consortium. Successful investigational products from the Healey ALS MyMatch program may advance to future regimens of the HEALEY ALS Platform Trial – a perpetual, multi-regimen, late-phase clinical efficacy study – or transition directly to standalone Phase 3 trials."

New P2 trial • Amyotrophic Lateral Sclerosis

Tiziana Life Sciences to Present at BIO-Europe in Vienna, Highlighting Innovative Immunomodulation Therapy (GlobeNewswire) - "The Company’s presentation will focus on its innovative nasal delivery platform and lead candidate, intranasal foralumab—the only fully human anti-CD3 monoclonal antibody in clinical development. This proprietary approach aims to enhance efficacy, safety, and tolerability over traditional intravenous methods, targeting neuroinflammatory and neurodegenerative diseases such as non-active secondary progressive multiple sclerosis (na-SPMS), Multiple System Atrophy (MSA), and early Alzheimer’s disease."

Clinical • Alzheimer's Disease • Multiple Sclerosis • Multiple System Atrophy

INFORM-MS: Study design of a Phase 2a double blind placebo-controlled trial of nasal foralumab in non-active secondary progressive multiple sclerosis (ECTRIMS 2025) - P1, P2 | "Nasal foralumab is being investigated in non-active SPMS in this multicenter phase 2a trial, which includes TSPO-PET scan as a primary outcome measure."

Clinical • P2a data • CNS Disorders • Inflammation • Multiple Sclerosis

Nasal foralumab induces a regulatory immune response (TGFb) and decreases immune activation (B2M and STAT1) in non-active secondary progressive MS subjects within the first six months of treatment (ECTRIMS 2025) - "These results demonstrate that nasally administered foralumab modulates immune response as early as three months following treatment start, with a sustained response at six months. Treated subjects had stable EDSS scores across the evaluation period, and no incidence of relapse."

Clinical • Multiple Sclerosis • Otorhinolaryngology • B2M • CD14 • CD8 • FOXP3 • STAT1 • TGFB1

At the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 24-26, in Barcelona, Spain, researchers shared the design of a placebo-controlled, phase 2a trial, dubbed INFORM-MS (NCT06292923)... (NeurologyLive) - "This multicenter, parallel-group study includes 54 patients with na-SPMS who are randomly assigned to either 2 doses of foralumab (50 μg or 100 μg), an anti-CD3 antibody, or placebo, for a 12-week treatment period. In addition to safety and tolerability, the study employs a unique primary outcome of change in microglial activation as measured by [18F]PBR06 TSPO PET....As of March 31, 2025, 17 of the expected 54 patients had been enrolled, with 9 randomized to treatment, and 7 who completed the core phase of the study."

Clinical protocol • Trial status • Multiple Sclerosis

Tiziana to Advance TZLS-501 - Its Fully Human IL-6R Monoclonal Antibody (GlobeNewswire) - "Tiziana will pursue non-dilutive funding strategies for the development of TZLS-501 while continuing to advance intranasal foralumab as its lead program....Tiziana sees potential to develop TZLS-501 as a monotherapy, or in combination with its lead candidate, foralumab, as well as with other anti-inflammatory and anti-infective agents."

Clinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Idiopathic Pulmonary Fibrosis • Immunology • Multiple Sclerosis • Multiple System Atrophy • Rheumatoid Arthritis

Tiziana Life Sciences Announces Poster Presentation on Intranasal Foralumab Clinical Trial at the 41st ECTRIMS Congress (GlobeNewswire) - "The poster...will outline the clinical trial design and objectives for Tiziana's innovative nasal foralumab program."

Clinical protocol • Multiple Sclerosis

A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=5 | Recruiting | Sponsor: Tiziana Life Sciences LTD | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy (Tiziana Life Sciences Press Release) - "The Phase 2a study (ClinicalTrials.gov Identifier: NCT06868628) 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."

IND • Trial status • Multiple System Atrophy

Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy (GlobeNewswire) - "The six-month open-label study...will assess the potential of foralumab to reduce harmful neuroinflammation by engaging the body’s regulatory T cells through a novel, non-systemic delivery approach."

Trial status • Multiple System Atrophy

Tiziana Life Sciences Announces Immunologic Analysis of Nasal Foralumab in Moderate Alzheimer’s Patient (Tiziana Life Sciences Press Release) - "Tiziana Life Sciences...announced compelling immunologic findings from the treatment of a moderate Alzheimer’s Disease (AD) patient with intranasal foralumab...Transcriptional analysis of white blood cells before and after foralumab therapy revealed profound immune modulatory effects. Significant changes were observed in CD4 cells, CD8 cells, and monocytes, underscoring the broad impact of nasal foralumab on immune cell profiles. These results are consistent with improvement in microglia PET scans conducted at the time of immune analysis which demonstrated a marked reduction in inflammation following nasal foralumab (Clin Nuclear Med) showing a link between immune effects and resolution of brain inflammation....Furthermore, the treatment was well tolerated with no reported side effects. Encouraged by these results and the observed behavioral improvements reported by the patient’s family, the patient and his wife have chosen to continue nasal foralumab..."

Clinical • Alzheimer's Disease

Nasal foralumab treatment of PIRA induces regulatory immunity, dampens microglial activation and stabilizes clinical progression in non-active secondary progressive MS. (PubMed, medRxiv) - "These findings identify a novel, non-toxic immune based therapy for the treatment for PIRA that acts by the induction of a regulatory immune responses and dampens microglial inflammation. Double blind placebo-controlled trials are warranted to explore nasal foralumab for the treatment of naSPMS."

Journal • CNS Disorders • Fatigue • Immunology • Inflammation • Multiple Sclerosis • Otorhinolaryngology • CD14 • CD8 • FOXP3 • TGFB1

Tiziana Life Sciences Expands Phase 2 Clinical Trial of Intranasal Foralumab with Commencement of First Patient Dosing at Weill Cornell Multiple Sclerosis Center (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announces that dosing has commenced at the prestigious Weill Cornell Medicine Multiple Sclerosis Center in New York City, in its ongoing Phase 2 clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This fifth site complements existing sites at Yale University, Johns Hopkins University, Brigham and Women's Hospital, and the University of Massachusetts."

Trial status • Multiple Sclerosis

Tiziana Life Sciences to Present at the Bio International Convention (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announces that its CEO, Ivor Elrifi, will be giving an oral presentation during the Bio International Convention in Boston, MA. Mr Elrifi’s presentation will cover the recent clinical findings of Tiziana’s lead drug candidate, intranasal foralumab. Foralumab is the first fully human anti-CD3 monoclonal antibody administered via the intranasal route. This novel, non-systemic approach is designed to engage regulatory T cells, promoting immune tolerance while minimizing systemic immune suppression."

Clinical data • Immunology • Inflammation

Dampening of Microglial Activation With Nasal Foralumab Administration in Moderate Alzheimer's Disease Dementia. (PubMed, Clin Nucl Med) - "18F-PBR06-PET, utilizing a second-generation 18-kDa-translocator-protein ligand targeting microglia, showed diffuse reduction of radiotracer uptake throughout the brain, following 3 months of nasal-foralumab compared with baseline. In particular, precuneus, posterior cingulate and anterior cingulate gyri, regions that had high levels of amyloid deposition on a baseline 18F-Florbetapir-PET scan, showed reduction in microglial activation after nasal-foralumab treatment for 3 months."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation

Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer's Patient Treated with Intranasal Foralumab (GlobeNewswire) - P=NA | N=NA | "Tiziana Life Sciences...today announced results of a PET scan showing a marked reduction in microglia activation associated with neuroinflammation in a patient suffering from moderate Alzheimer's disease (AD) who was treated for three months with intranasal foralumab under an expanded access program....This PET scan result showing a dampening of microglial activation by nasal foralumab in a patient with moderate Alzheimer’s disease, demonstrates the potential for foralumab to fight many neurologic diseases by treating neuroinflammation."

Clinical data • Alzheimer's Disease

Tiziana Life Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis (GlobeNewswire) - P=NA | N=10 | "No serious or severe treatment-related adverse events were reported; All patients experienced stabilization of their Expanded Disability Status Scale (EDSS) scores; three of four patients that were treated continuously for 12 months showed improvement; Fatigue, a major symptom burden in MS, improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS); Total MFIS scores correlated strongly with mGALP scores in the hippocampus (r=0.89, p=0.007) at baseline; No new T2 lesions were observed on MRI; TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05)....In parallel with these encouraging results, Tiziana Life Sciences has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further assess the efficacy and safety of nasal foralumab in a larger cohort of patients with na-SPMS. This trial is expected to reach top line data read out at the end of 2025."

Clinical data • P2a data • Multiple Sclerosis

Tiziana Life Sciences Announces University of Massachusetts Commences Dosing Intranasal Foralumab in Phase 2 Multiple Sclerosis Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS). The University of Massachusetts (UMass) has now joined Brigham and Women’s Hospital (BWH), Yale Multiple Sclerosis Center, and Johns Hopkins University (JHU) Autoimmunity Center of Excellence in actively dosing participants....This blinded, placebo-controlled trial is expected to be completed by the end of 2025."

Trial status • Multiple Sclerosis

INDUCTION OF AMYLOID CLEARING MONOCTYTES WITH NASAL PROTOLLIN AND MICROGLIAL DAMPENING TREGS WITH NASAL FORALUMAB TO TREAT ALZHEIMER'S DISEASE (ADPD 2025) - "Nasal Foralumab could be a treatment for ARIA. Phase 2 placebo controlled trials of nasal Protollin and nasal Foralumab in early AD are being undertaken."

IO biomarker • Alzheimer's Disease • CNS Disorders • Hematological Disorders • Multiple Sclerosis • IL10 • NKG7 • TGFB1

Tiziana Life Sciences Announces Yale University Commences Intranasal Foralumab Dosing in Phase 2 Multiple Sclerosis Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Other centers are currently enrolling include Johns Hopkins, U Mass Medical Center and Brigham and Women’s Hospital....The double blinded, multicenter placebo-controlled Phase 2 trial is expected to be completed by the end of 2025."

Trial status • Multiple Sclerosis

TILS-022: Nasal Foralumab in Patients with Non-Active Secondary Progressive Multiple Sclerosis (clinicaltrials.gov) - P2 | N=55 | Recruiting | Sponsor: Tiziana Life Sciences LTD

New P2 trial • CNS Disorders • Multiple Sclerosis

Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial (GlobeNewswire) - "Tiziana Life Sciences, Ltd...today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS....Upon FDA clearance of the IND application, Tiziana plans to commence a 20-patient clinical trial of two doses of Tiziana’s novel and patented therapeutic candidate, intranasal foralumab, aimed at evaluating the safety and early-stage parameters of disease improvement in Amyotrophic Lateral Sclerosis (ALS)."

IND • New P2 trial • Amyotrophic Lateral Sclerosis

Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Tiziana Life Sciences LTD

New P1 trial

A Phase 2a Study of Foralumab Nasal in Patients with Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: Brigham and Women's Hospital

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy