Tiziana Life Sciences Announces University of Massachusetts Commences Dosing Intranasal Foralumab in Phase 2 Multiple Sclerosis Trial
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at the University of Massachusetts, the fourth clinical site in its ongoing Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS). UMass joins Brigham and Women's Hospital, Yale Multiple Sclerosis Center, and Johns Hopkins University in the study.
The blinded, placebo-controlled trial is expected to conclude by end-2025, followed by a six-month open-label extension phase where all participants can receive the treatment. Foralumab, the first fully human anti-CD3 monoclonal antibody administered intranasally, is designed to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression.
The intranasal administration allows for at-home dosing, potentially improving compliance compared to intravenous treatments, particularly beneficial for patients dealing with fatigue.
Tiziana Life Sciences (Nasdaq: TLSA) ha annunciato l'inizio della somministrazione presso la University of Massachusetts, il quarto centro clinico nel suo attuale studio di Fase 2 sul foralumab intranasale per la sclerosi multipla secondaria progressiva non attiva (na-SPMS). UMass si unisce al Brigham and Women's Hospital, al Yale Multiple Sclerosis Center e alla Johns Hopkins University nello studio.
Lo studio in cieco, controllato con placebo, è previsto concludersi entro la fine del 2025, seguito da una fase di estensione a etichetta aperta di sei mesi durante la quale tutti i partecipanti potranno ricevere il trattamento. Il foralumab, il primo anticorpo monoclonale anti-CD3 completamente umano somministrato per via intranasale, è progettato per attivare le cellule T regolatorie e favorire la tolleranza immunitaria, minimizzando al contempo la soppressione immunitaria sistemica.
La somministrazione intranasale consente di effettuare il trattamento a casa, migliorando potenzialmente l’aderenza rispetto alle terapie endovenose, particolarmente utile per i pazienti affetti da affaticamento.
Tiziana Life Sciences (Nasdaq: TLSA) ha anunciado el inicio de la dosificación en la University of Massachusetts, el cuarto centro clínico en su ensayo de Fase 2 en curso sobre foralumab intranasal para esclerosis múltiple secundaria progresiva no activa (na-SPMS). UMass se une al Brigham and Women's Hospital, al Yale Multiple Sclerosis Center y a la Johns Hopkins University en el estudio.
El ensayo aleatorizado, doble ciego y controlado con placebo se espera que concluya a finales de 2025, seguido de una fase de extensión abierta de seis meses donde todos los participantes podrán recibir el tratamiento. Foralumab, el primer anticuerpo monoclonal anti-CD3 completamente humano administrado por vía intranasal, está diseñado para activar las células T reguladoras y promover la tolerancia inmunológica mientras minimiza la supresión inmune sistémica.
La administración intranasal permite la dosificación en casa, mejorando potencialmente el cumplimiento en comparación con los tratamientos intravenosos, lo cual es especialmente beneficioso para pacientes que sufren de fatiga.
Tiziana Life Sciences (나스닥: TLSA)는 University of Massachusetts에서 비활성 이차 진행성 다발성 경화증(na-SPMS)을 위한 비강 내 포랄루맙 2상 임상시험의 네 번째 임상 사이트에서 투약을 시작했다고 발표했습니다. UMass는 브리검 여성 병원, 예일 다발성 경화증 센터, 존스 홉킨스 대학교와 함께 연구에 참여합니다.
이중맹검 위약 대조 시험은 2025년 말까지 완료될 예정이며, 이후 6개월간 모든 참가자가 치료를 받을 수 있는 공개 라벨 연장 단계가 진행됩니다. 포랄루맙은 비강 내 투여되는 최초의 완전 인간형 항-CD3 단클론 항체로, 조절 T 세포를 활성화하여 면역 관용을 촉진하고 전신 면역 억제를 최소화하도록 설계되었습니다.
비강 내 투여 방식은 가정에서 투약이 가능해 정맥 주사 치료에 비해 복약 순응도를 높일 수 있으며, 특히 피로를 겪는 환자에게 유리합니다.
Tiziana Life Sciences (Nasdaq : TLSA) a annoncé le début de l'administration à la University of Massachusetts, le quatrième centre clinique de son essai de phase 2 en cours sur le foralumab intranasal pour la sclérose en plaques progressive secondaire non active (na-SPMS). UMass rejoint le Brigham and Women's Hospital, le Yale Multiple Sclerosis Center et l'Université Johns Hopkins dans cette étude.
L'essai en double aveugle contrôlé par placebo devrait se terminer d'ici fin 2025, suivi d'une phase d'extension en ouvert de six mois où tous les participants pourront recevoir le traitement. Le foralumab, le premier anticorps monoclonal anti-CD3 entièrement humain administré par voie intranasale, est conçu pour activer les cellules T régulatrices et favoriser la tolérance immunitaire tout en minimisant la suppression immunitaire systémique.
L'administration intranasale permet une prise à domicile, améliorant potentiellement l'observance par rapport aux traitements intraveineux, ce qui est particulièrement bénéfique pour les patients souffrant de fatigue.
Tiziana Life Sciences (Nasdaq: TLSA) hat den Beginn der Dosierung an der University of Massachusetts bekannt gegeben, dem vierten klinischen Standort in ihrer laufenden Phase-2-Studie zu intranasalem Foralumab bei nicht-aktiver sekundär progredienter Multipler Sklerose (na-SPMS). UMass ergänzt das Brigham and Women's Hospital, das Yale Multiple Sclerosis Center und die Johns Hopkins University in der Studie.
Die verblindete, placebokontrollierte Studie soll bis Ende 2025 abgeschlossen sein, gefolgt von einer sechsmonatigen offenen Verlängerungsphase, in der alle Teilnehmer die Behandlung erhalten können. Foralumab, der erste vollständig humane anti-CD3 monoklonale Antikörper, der intranasal verabreicht wird, ist darauf ausgelegt, regulatorische T-Zellen zu aktivieren und die Immun-Toleranz zu fördern, während die systemische Immunsuppression minimiert wird.
Die intranasale Verabreichung ermöglicht die Behandlung zu Hause, was die Therapietreue im Vergleich zu intravenösen Behandlungen potenziell verbessert und insbesondere für Patienten mit Müdigkeit von Vorteil ist.
- Addition of fourth prestigious clinical site (UMass) demonstrates growing scientific community interest
- At-home intranasal administration could improve patient compliance versus traditional IV treatments
- Novel non-systemic treatment approach targeting immune tolerance
- Trial results not expected until end of 2025
- Still in Phase 2 testing with uncertain outcomes
Insights
Tiziana's MS trial expands to fourth site, demonstrating institutional interest in novel intranasal delivery approach for underserved patients.
Tiziana's expansion of its Phase 2 trial to a fourth prestigious academic center represents positive operational momentum for its lead candidate. The company has now engaged University of Massachusetts alongside Brigham and Women's Hospital, Yale, and Johns Hopkins - all top-tier institutions with significant neurological expertise. This broadening institutional participation suggests growing scientific interest in foralumab's novel approach.
The company strategically targets non-active secondary progressive MS (na-SPMS), a patient population with severely treatment options. The trial design includes both a blinded placebo-controlled phase and a subsequent open-label extension, allowing for rigorous efficacy assessment followed by longer-term safety evaluation.
The intranasal administration route offers two potential competitive advantages: it enables home-based treatment, addressing compliance challenges for patients with mobility limitations and fatigue, and it potentially delivers a more targeted immunomodulatory effect with reduced systemic exposure. This approach contrasts with conventional intravenous MS therapies that require clinical visits.
As the first fully human anti-CD3 monoclonal antibody administered intranasally, foralumab employs a differentiated mechanism targeting regulatory T cells to promote immune tolerance. This approach aligns with current understanding of MS pathophysiology as fundamentally autoimmune in nature. The trial's expected completion by end-2025 establishes a clear timeline for potential clinical catalysts.
Foralumab's intranasal delivery and T-cell modulation approach addresses key treatment challenges in progressive MS where options are
The addition of UMass as the fourth site in Tiziana's Phase 2 trial highlights the significant clinical interest in novel approaches for non-active secondary progressive MS. This form of MS represents a particularly challenging treatment landscape, with patients experiencing gradual neurological deterioration that current therapies largely fail to address.
Foralumab's mechanism targeting regulatory T cells to induce immune tolerance addresses the fundamental autoimmune dysfunction in MS. This approach could potentially modify disease progression beyond symptom management, though efficacy remains to be demonstrated in the current trial.
The intranasal administration route directly addresses a major treatment barrier in progressive MS. Patients with advancing disability and fatigue often struggle with the logistical burden of regular clinic visits required for standard MS therapies. Home administration could significantly improve treatment adherence in this mobility-challenged population.
The trial's design with a blinded phase followed by open-label extension balances scientific rigor with compassionate access, allowing all participants eventual access to the investigational treatment. This approach is particularly appropriate for progressive conditions where patients have few alternatives. The engagement of multiple leading MS research centers suggests confidence in the scientific rationale, though ultimate efficacy determination awaits trial completion.
NEW YORK, April 23, 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 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. Following the completion of the blinded phase, all participants—including those who initially received placebo—will have the opportunity to receive intranasal foralumab during a six-month open-label extension (OLE) phase. The OLE is designed to assess long-term safety and sustained benefit, of foralumab in the na-SPMS patient population.
“We are excited to add UMass as a clinical site in our Phase 2 trial. The increasing the number of premier institutions participating in our study reflects great enthusiasm within the scientific and medical communities for intranasal foralumab as a potential treatment for patients with non-active SPMS,” said William A. Clementi, PharmD, Chief Development Officer of Tiziana Life Sciences. “We remain committed to advancing this important research as we work toward a much-needed new treatment for this underserved patient population. Intranasal dosing allows foralumab to be administered at home. Our hope is that this improves compliance and outcomes versus more commonly seen intravenous dosing which can be a burden on a patient population who suffer with fatigue, and who would normally need to attend a clinic.”
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented, “The initiation of dosing at UMass marks another significant step forward in our mission to bring foralumab to patients living with non-active SPMS. We are grateful for the dedication of our investigators and research teams across all sites, as well as the patients who are participating in this trial. We look forward to the completion of the study and the insights it will provide into the potential benefits of 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.
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, 2023, 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 will Tiziana's (TLSA) Phase 2 trial for intranasal foralumab in multiple sclerosis complete?
Which clinical sites are participating in TLSA's Phase 2 multiple sclerosis trial?
What are the advantages of Tiziana's (TLSA) intranasal foralumab administration?
What type of multiple sclerosis is TLSA's foralumab targeting in the Phase 2 trial?
