Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy
Tiziana Life Sciences (NASDAQ:TLSA) has initiated dosing in its Phase 2a clinical trial of intranasal foralumab for Multiple System Atrophy (MSA) at Brigham and Women's Hospital in Boston. The six-month open-label study will evaluate foralumab's potential to reduce neuroinflammation in MSA patients through a novel nasal delivery system.
MSA is a rare neurodegenerative disorder affecting 15,000-50,000 people in the United States, with no FDA-approved treatments to alter disease progression. The trial (NCT06868628) will involve eight dosing cycles to assess the therapy's ability to slow disease progression and enhance quality of life through regulatory T cell engagement.
Tiziana Life Sciences (NASDAQ:TLSA) ha avviato la somministrazione nella sua sperimentazione clinica di fase 2a con foralumab per via intranasale per la Atrofia Multisistemica (MSA) presso il Brigham and Women's Hospital di Boston. Lo studio aperto della durata di sei mesi valuterà il potenziale del foralumab di ridurre la neuroinfiammazione nei pazienti con MSA attraverso un innovativo sistema di somministrazione nasale.
L'MSA è una rara patologia neurodegenerativa che interessa 15.000-50.000 persone negli Stati Uniti e non dispone di terapie approvate dalla FDA in grado di modificare la progressione della malattia. Lo studio (NCT06868628) prevede otto cicli di somministrazione per valutare la capacità della terapia di rallentare la progressione della malattia e migliorare la qualità della vita mediante l'attivazione delle cellule T regolatorie.
Tiziana Life Sciences (NASDAQ:TLSA) ha iniciado la administración en su ensayo clínico de fase 2a con foralumab intranasal para la Atrofia Multisistémica (MSA) en el Brigham and Women's Hospital de Boston. El estudio abierto de seis meses evaluará el potencial de foralumab para reducir la neuroinflamación en pacientes con MSA mediante un novedoso sistema de administración nasal.
La MSA es una enfermedad neurodegenerativa rara que afecta a 15.000-50.000 personas en Estados Unidos y no cuenta con tratamientos aprobados por la FDA que modifiquen la progresión de la enfermedad. El ensayo (NCT06868628) incluirá ocho ciclos de dosificación para valorar la capacidad de la terapia de ralentizar la progresión y mejorar la calidad de vida mediante la activación de las células T reguladoras.
Tiziana Life Sciences (NASDAQ:TLSA)가 보스턴의 브리검 여성 병원(Brigham and Women's Hospital)에서 다계통 위축증(MSA)을 대상으로 하는 비강 투여 포랄루맙의 2a상 임상시험에서 투약을 시작했습니다. 6개월 기간의 공개 라벨(오픈라벨) 연구는 혁신적인 비강 투여 시스템을 통해 포랄루맙이 MSA 환자의 신경 염증을 감소시킬 수 있는지를 평가합니다.
MSA는 미국에서 15,000-50,000명가 고통받는 드문 신경퇴행성 질환으로, 질병 진행을 바꿀 수 있는 FDA 승인 치료법이 없습니다. 본 임상시험(NCT06868628)은 8회 투약 사이클을 포함하여 치료가 조절 T 세포의 관여를 통해 질병 진행을 늦추고 삶의 질을 향상시킬 수 있는지를 평가할 예정입니다.
Tiziana Life Sciences (NASDAQ:TLSA) a commencé les administrations dans son essai clinique de phase 2a évaluant le foralumab intranasal pour l'atrophie multisystémique (MSA) au Brigham and Women's Hospital de Boston. L'étude ouverte de six mois examinera si le foralumab, via un nouveau système d'administration nasale, peut réduire la neuroinflammation chez les patients atteints de MSA.
La MSA est une maladie neurodégénérative rare touchant 15 000 à 50 000 personnes aux États-Unis, et il n'existe aucun traitement approuvé par la FDA permettant de modifier la progression de la maladie. L'essai (NCT06868628) comprendra huit cycles de dosage afin d'évaluer la capacité de la thérapie à ralentir l'évolution de la maladie et à améliorer la qualité de vie par l'activation des cellules T régulatrices.
Tiziana Life Sciences (NASDAQ:TLSA) hat mit der Dosierung in ihrer Phase-2a-Studie mit intranasalem Foralumab bei Multipler Systematrophie (MSA) am Brigham and Women's Hospital in Boston begonnen. Die sechsmonatige, offene Studie wird untersuchen, ob Foralumab über ein neuartiges nasales Applikationssystem die Neuroinflammation bei MSA-Patienten reduzieren kann.
MSA ist eine seltene neurodegenerative Erkrankung, die 15.000–50.000 Menschen in den Vereinigten Staaten betrifft und für die es keine von der FDA zugelassenen Therapien zur Veränderung des Krankheitsverlaufs gibt. Die Studie (NCT06868628) umfasst acht Dosierungszyklen, um die Fähigkeit der Therapie zu bewerten, das Fortschreiten der Erkrankung zu verlangsamen und die Lebensqualität durch Aktivierung regulatorischer T‑Zellen zu verbessern.
- First patient dosed in Phase 2a trial for MSA, an orphan disease with no current FDA-approved treatments
- Novel intranasal delivery system targeting brain inflammation through non-systemic approach
- Building on previous positive research of foralumab in neuroinflammatory conditions like multiple sclerosis
- Open-label study design may limit data interpretation
- Small target market with only 15,000-50,000 MSA patients in the US
Insights
Tiziana's Phase 2a trial for intranasal foralumab in MSA represents an important clinical milestone targeting a disease with no effective treatments.
Tiziana Life Sciences has dosed the first patient in its Phase 2a trial for intranasal foralumab, marking a significant clinical advancement in their pipeline. This trial targets Multiple System Atrophy (MSA), a rare and rapidly progressive neurodegenerative disorder affecting between 15,000-50,000 Americans with no FDA-approved disease-modifying treatments.
What makes this trial particularly noteworthy is foralumab's unique delivery method and mechanism of action. As a fully human anti-CD3 monoclonal antibody administered intranasally, it aims to reduce neuroinflammation by specifically targeting and activating regulatory T cells through a non-systemic approach. This drug delivery pathway potentially offers better CNS target engagement with reduced systemic side effects compared to traditional approaches.
The six-month open-label study (NCT06868628) conducted at Brigham and Women's Hospital will evaluate eight dosing cycles, focusing on safety, tolerability, and preliminary signals of efficacy in slowing disease progression. For a rare neurodegenerative disorder with limited therapeutic options, advancing to Phase 2a represents a meaningful milestone in addressing an area of significant unmet medical need.
This trial builds on Tiziana's broader research program exploring foralumab in neuroinflammatory conditions, where they've reportedly seen encouraging early results in conditions like multiple sclerosis. For investors, this expansion into orphan indications could potentially qualify for accelerated regulatory pathways if the data proves promising.
BOSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients living with Multiple System Atrophy (MSA) at Brigham and Women’s Hospital in Boston, Massachusetts.
MSA is a rare, rapidly progressive neurodegenerative disorder affecting the body’s movement, balance, and autonomic functions. Classified as an orphan disease by the FDA, MSA affects an estimated 15,000–50,000 people in the United States. There are no FDA-approved treatments that alter its course, creating a critical need for new therapeutic strategies.
The six-month open-label study (ClinicalTrials.gov Identifier: NCT06868628) 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. Participants will receive treatment over eight dosing cycles, with the goal of determining whether this approach can slow disease progression and improve quality of life.
“We are excited to begin dosing nasal foralumab in MSA patients,” Said Dr. Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair in Neurology, and Division Chief of Movement Disorders and Director of the MSA Center of Excellence at Brigham and Women’s Hospital and Principal Investigator of the MSA trial, commented: “Every patient I meet with MSA faces a reality of mounting symptoms and few options. This trial represents an important opportunity to explore a treatment aimed directly at the immune processes that may drive the disease. The intranasal route allows us to reach the brain’s immune environment in a way that is both targeted and potentially more tolerable for patients.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, added: “Our mission is to bring forward therapies that tackle the root causes of neurodegeneration, not just the symptoms. Dosing our first patient in this MSA study marks an important milestone in that mission. We are hopeful that foralumab’s unique mechanism – modulating immune response through the nasal pathway – can open new doors in treating diseases where inflammation and degeneration are intertwined.”
The trial builds on Tiziana’s broader research into foralumab in neuroinflammatory and neurodegenerative diseases, where early studies have suggested benefits in stabilizing or improving function in conditions such as multiple sclerosis.
About Multiple System Atrophy
Multiple System Atrophy is a rare and debilitating disorder involving the progressive loss of nerve cells in several areas of the brain. Symptoms may include severe problems with movement, balance, bladder control, and blood pressure regulation. The disease progresses quickly, and most patients survive only 6–9 years after diagnosis. No treatments are currently approved to slow or halt its progression.
About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What is the purpose of Tiziana Life Sciences' Phase 2a trial for MSA?
How many patients are affected by Multiple System Atrophy in the United States?
What is the duration and structure of TLSA's Phase 2a MSA trial?
Are there any FDA-approved treatments for Multiple System Atrophy?
How is Tiziana's foralumab different from other MSA treatments?
