Tiziana Life Sciences Announces Poster Presentation on Intranasal Foralumab Clinical Trial at the 41st ECTRIMS Congress
Tiziana Life Sciences (NASDAQ:TLSA) announced its upcoming poster presentation at the 41st ECTRIMS Congress in Barcelona, Spain, from September 24-26, 2025. The presentation will focus on the Phase 2a clinical trial design for nasal foralumab, the first fully human anti-CD3 monoclonal antibody designed for intranasal delivery.
The study targets non-active secondary progressive multiple sclerosis patients, representing a novel approach to immune system modulation. The presentation, titled "Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis," will be showcased at ECTRIMS, the world's largest annual international conference for MS research.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato la prossima poster presso il 41° Congresso ECTRIMS a Barcellona, in Spagna, dal 24 al 26 settembre 2025. La presentazione si concentrerà sul design dello studio di fase 2a per il foralumab nasale, il primo anticorpo monoclonale anti-CD3 interamente umano progettato per somministrazione intranasale.
Lo studio si rivolge a pazienti con sclerosi multipla secondaria progressiva non attiva, rappresentando un nuovo approccio alla modulazione del sistema immunitario. La presentazione, intitolata Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis, sarà mostrata a ECTRIMS, la più grande conferenza internazionale annuale dedicata alla ricerca sulla SM.
Tiziana Life Sciences (NASDAQ: TLSA) anunció su próxima póster en el 41º Congreso ECTRIMS en Barcelona, España, del 24 al 26 de septiembre de 2025. La presentación se centrará en el diseño del ensayo clínico de fase 2a para el foralumab nasal, el primer anticuerpo monoclonal anti-CD3 totalmente humano diseñado para administración intranasal.
El estudio está dirigido a pacientes con esclerosis múltiple secundaria progresiva no activa, representando un enfoque novedoso para la modulación del sistema inmunológico. La presentación, titulada Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis, se mostrará en ECTRIMS, la mayor conferencia internacional anual de investigación sobre la esclerosis múltiple.
Tiziana Life Sciences (NASDAQ: TLSA)는 제41회 ECTRIMS 학술대회가 바르셀로나(스페인)에서 2025년 9월 24-26일 열릴 예정이라고 발표했습니다. 발표는 비강 포랄루맙의 위상 2a 임상시험 설계에 초점을 맞추며, 비강 투여를 위해 설계된 최초의 완전 인간화 anti-CD3 단일클론 항체입니다.
본 연구는 비활성 비활성형 이차 진행성 다발성 경화증(Non-Active Secondary Progressive Multiple Sclerosis) 환자를 대상으로 하며 면역 체계 조절에 대한 새로운 접근법을 제시합니다. 발표 제목은 Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis이며, MS 연구를 위한 세계 최대 연례 국제 학술대회인 ECTRIMS에서 공개될 예정입니다.
Tiziana Life Sciences (NASDAQ:TLSA) a annoncé sa prochaine affiche lors du 41e Congrès ECTRIMS à Barcelone, en Espagne, du 24 au 26 septembre 2025. La présentation portera sur le design de l’essai clinique de phase 2a pour le foralumab nasal, le premier anticorps monoclonal anti-CD3 entièrement humain conçu pour une administration intranasale.
L’étude cible des patients atteints de sclérose en plaques secondaire progressive non active, représentant une approche nouvelle de la modulation du système immunitaire. La présentation, intitulée Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis, sera présentée au ECTRIMS, la plus grande conférence internationale annuelle sur la recherche MS.
Tiziana Life Sciences (NASDAQ: TLSA) hat seine/ihre kommende Poster-Präsentation auf dem 41. ECTRIMS-Kongress in Barcelona, Spanien, vom 24. bis 26. September 2025 angekündigt. Die Präsentation konzentriert sich auf das Phase-2a-Studiendesign für das nasale Foralumab, den ersten vollständig menschlichen anti-CD3-Monoklonalen Antikörper, der für eine intranasale Verabreichung entwickelt wurde.
Die Studie richtet sich an Patienten mit nicht aktiver sekundär progredienter Multipler Sklerose, und stellt einen neuartigen Ansatz zur Modulation des Immunsystems dar. Die Präsentation, mit dem Titel Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis, wird beim ECTRIMS vorgestellt, der weltweit größten jährlichen internationalen Konferenz zur MS-Forschung.
أعلنت Tiziana Life Sciences (المدرجة في NASDAQ: TLSA) عن عرض ملصقها القادم في المؤتمر 41st ECTRIMS في برشلونة، إسبانيا، من 24 إلى 26 سبتمبر 2025. ستركّز العرض على تصميم تجربة المرحلة 2a السريرية لـ foralumab الأنفي، وهو أول جسم مضاد أحادي النسيلة ضد CD3 بالكامل بشري صُمِّم للإعطاء عبر الأنف.
تستهدف الدراسة مرضى التصلب المتعدد التقدّمي الثانوي غير النشط، ممثّلة نهجاً جديداً في تعديل الجهاز المناعي. سوف تُعرَض في ECTRIMS، أكبر مؤتمرات MS الدولي السنوي.
Tiziana Life Sciences (NASDAQ: TLSA)宣布将在巴塞罗那（西班牙）举行的第41届ECTRIMS大会上展示海报，时间为2025年9月24日至26日。此次演讲将聚焦鼻部 foralumab 的 IIa 期临床试验设计，这是首个为经鼻给药而设计的全人源 anti-CD3 单抗。研究对象为非活跃型的继发性进展性多发性硬化症患者，代表一种全新的免疫系统调控方法。此次演讲题为 Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis，将在 ECTRIMS 上展示，ECTRIMS 是全球最大的年度多发性硬化研究国际会议。
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BOSTON, Sept. 24, 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 it will present a scientific poster at the 41st Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS), being held September 24-26, 2025, in Barcelona, Spain. The ECTRIMS Congress is the world’s largest annual international conference dedicated to basic and clinical research in multiple sclerosis. It brings together leading scientists, clinicians, and industry partners to share the latest advances in MS research and treatment.
The poster, titled "Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis," will outline the clinical trial design and objectives for Tiziana's innovative nasal foralumab program. Nasal foralumab is the first entirely human anti-CD3 monoclonal antibody designed for intranasal delivery, representing a novel approach to modulating the immune system for the treatment of non-active secondary progressive multiple sclerosis.
Presentation Details:
- Title: Study Design of a Phase 2a Double-Blind Placebo-Controlled Trial of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis
- Format: Poster Presentation
- Event: 41st ECTRIMS Congress
- Date: September 24-26, 2025
- Location: Barcelona, Spain
“We are pleased to share the design of our Phase 2a trial of nasal foralumab with the MS research community at ECTRIMS,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “This clinical trial represents an important step forward in our mission to develop innovative therapies for patients living with non-active secondary progressive multiple sclerosis, a population with limited treatment options.”
About ECTRIMS
The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress is the world’s largest annual international conference dedicated to basic and clinical research in multiple sclerosis. It brings together leading scientists, clinicians, and industry partners to share the latest advances in MS research and treatment. The ECTRIMS congress is a non-profit organization and an independent representative European-wide organization devoted to multiple sclerosis (MS). It serves as Europe’s and the world’s largest professional organization dedicated to the understanding and treatment of MS.
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.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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
When and where will Tiziana Life Sciences (TLSA) present at the ECTRIMS Congress 2025?
What is the focus of TLSA's poster presentation at ECTRIMS 2025?
What makes Tiziana's nasal foralumab unique in multiple sclerosis treatment?
Which patient population is Tiziana Life Sciences targeting with nasal foralumab?
