Tiziana Life Sciences Announces Yale University Commences Intranasal Foralumab Dosing in Phase 2 Multiple Sclerosis Trial
Tiziana Life Sciences (NASDAQ: TLSA) has commenced dosing new patients at Yale MS Center as part of its multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial is also enrolling at Johns Hopkins, U Mass Medical Center, and Brigham and Women's Hospital.
The double-blinded, placebo-controlled study aims to assess safety, tolerability, and foralumab's effect on microglial activation in na-SPMS patients. The trial combines brain PET imaging, immunology, and FDA-accepted clinical evidence measures.
Expected completion is by end of 2025, followed by a 6-month open-label extension (OLE) study to evaluate long-term safety, tolerability, and durable effectiveness. Foralumab, a fully human anti-CD3 monoclonal antibody, represents a novel approach to potentially mitigate SPMS progression.
Tiziana Life Sciences (NASDAQ: TLSA) ha iniziato a somministrare il trattamento a nuovi pazienti presso il Yale MS Center nell'ambito del suo studio clinico di fase 2 multicentrico che valuta foralumab intranasale per la Sclerosi Multipla Secondaria Progressiva Non Attiva (na-SPMS). Lo studio sta reclutando anche presso Johns Hopkins, U Mass Medical Center e Brigham and Women's Hospital.
Lo studio, in doppio cieco e controllato con placebo, mira a valutare la sicurezza, la tollerabilità e l'effetto del foralumab sull'attivazione microgliale nei pazienti con na-SPMS. La sperimentazione combina l'imaging PET cerebrale, l'immunologia e misure di evidenza clinica accettate dalla FDA.
Il completamento è previsto entro la fine del 2025, seguito da uno studio di estensione in aperto (OLE) di 6 mesi per valutare la sicurezza a lungo termine, la tollerabilità e l'efficacia duratura. Il foralumab, un anticorpo monoclonale anti-CD3 completamente umano, rappresenta un approccio innovativo per potenzialmente mitigare la progressione della SPMS.
Tiziana Life Sciences (NASDAQ: TLSA) ha comenzado a administrar tratamiento a nuevos pacientes en el Centro MS de Yale como parte de su ensayo clínico de fase 2 multicéntrico que evalúa foralumab intranasal para la Esclerosis Múltiple Secundaria Progresiva No Activa (na-SPMS). El ensayo también está reclutando en Johns Hopkins, U Mass Medical Center y Brigham and Women's Hospital.
El estudio, doble ciego y controlado con placebo, tiene como objetivo evaluar la seguridad, la tolerabilidad y el efecto del foralumab en la activación microglial en pacientes con na-SPMS. La prueba combina imágenes PET del cerebro, inmunología y medidas de evidencia clínica aceptadas por la FDA.
Se espera que se complete a finales de 2025, seguido de un estudio de extensión abierto (OLE) de 6 meses para evaluar la seguridad a largo plazo, la tolerabilidad y la efectividad duradera. El foralumab, un anticuerpo monoclonal anti-CD3 completamente humano, representa un enfoque novedoso para mitigar potencialmente la progresión de la SPMS.
티지아나 라이프 사이언스(Tiziana Life Sciences, NASDAQ: TLSA)는 비활성 2차 진행성 다발성 경화증(na-SPMS)을 평가하는 다기관 2상 임상 시험의 일환으로 예일 MS 센터에서 새로운 환자에게 투약을 시작했습니다. 이 시험은 존스 홉킨스, U 매사추세츠 메디컬 센터 및 브리검 여성 병원에서도 등록을 진행하고 있습니다.
이중 맹검, 위약 대조 연구는 na-SPMS 환자에서 안전성, 내약성 및 포랄루맙의 미세아교세포 활성화에 대한 영향을 평가하는 것을 목표로 하고 있습니다. 이 시험은 뇌 PET 이미징, 면역학 및 FDA에서 승인한 임상 증거 측정을 결합합니다.
예상 완료 시기는 2025년 말이며, 이후 6개월 간의 개방형 연장 연구(OLE)를 통해 장기 안전성, 내약성 및 지속적인 효과를 평가할 예정입니다. 포랄루맙은 완전 인간형 항-CD3 단클론 항체로, SPMS 진행을 완화할 수 있는 새로운 접근 방식을 나타냅니다.
Tiziana Life Sciences (NASDAQ: TLSA) a commencé à administrer un traitement à de nouveaux patients au Yale MS Center dans le cadre de son essai clinique multicentrique de phase 2 évaluant foralumab intranasal pour la Sclérose en Plaques Secondaire Progressive Non Active (na-SPMS). L'essai recrute également à Johns Hopkins, U Mass Medical Center et Brigham and Women's Hospital.
L'étude en double aveugle et contrôlée par placebo vise à évaluer la sécurité, la tolérance et l'effet du foralumab sur l'activation microgliale chez les patients atteints de na-SPMS. L'essai combine l'imagerie cérébrale par PET, l'immunologie et des mesures de preuves cliniques acceptées par la FDA.
La fin de l'étude est prévue pour fin 2025, suivie d'une étude d'extension ouverte (OLE) de 6 mois pour évaluer la sécurité à long terme, la tolérance et l'efficacité durable. Le foralumab, un anticorps monoclonal anti-CD3 entièrement humain, représente une approche novatrice pour potentiellement atténuer la progression de la SPMS.
Tiziana Life Sciences (NASDAQ: TLSA) hat mit der Verabreichung an neuen Patienten im Yale MS Center im Rahmen ihrer multizentrischen Phase-2-Studie begonnen, die intranasales Foralumab bei nicht aktiver sekundärer progressiver Multipler Sklerose (na-SPMS) bewertet. Die Studie rekrutiert auch an den Johns Hopkins, U Mass Medical Center und Brigham and Women's Hospital.
Die doppelblinde, placebo-kontrollierte Studie zielt darauf ab, die Sicherheit, Verträglichkeit und die Wirkung von Foralumab auf die Mikroglia-Aktivierung bei na-SPMS-Patienten zu bewerten. Die Studie kombiniert Gehirn-PET-Bildgebung, Immunologie und von der FDA akzeptierte klinische Evidenzmaßnahmen.
Der Abschluss wird bis Ende 2025 erwartet, gefolgt von einer 6-monatigen offenen Verlängerungsstudie (OLE), um die langfristige Sicherheit, Verträglichkeit und dauerhafte Wirksamkeit zu bewerten. Foralumab, ein vollständig menschlicher Anti-CD3-Monoklonantikörper, stellt einen neuartigen Ansatz dar, um möglicherweise das Fortschreiten der SPMS zu mildern.
- Phase 2 trial expanded to multiple prestigious medical centers
- Novel intranasal delivery method for MS treatment
- Additional 6-month open-label extension study planned
- Trial includes FDA-accepted clinical evidence measures
- Results not expected until end of 2025
- Still in early clinical phase (Phase 2) with uncertain outcomes
Insights
The announcement of Yale University beginning to dose patients in Tiziana's Phase 2 trial for intranasal foralumab represents a meaningful advancement in the company's clinical program. This multicenter trial studying non-active Secondary Progressive Multiple Sclerosis (na-SPMS) involves several prestigious institutions including Johns Hopkins and Brigham and Women's Hospital, enhancing the study's credibility.
The trial design is particularly notable as it combines brain PET imaging, immunological assessments, and FDA-accepted clinical endpoints - creating a comprehensive evaluation framework. Intranasal delivery of foralumab, a fully human anti-CD3 monoclonal antibody, offers a novel approach to immune modulation that could potentially address the significant unmet need in na-SPMS patients.
With trial completion projected for late 2025 and a planned 6-month open-label extension study, Tiziana has established a clear development timeline. This progress is significant because na-SPMS represents a challenging form of MS with effective treatment options. The immunomodulatory approach of foralumab targets the underlying inflammatory processes that contribute to disease progression.
While this Phase 2 milestone demonstrates continued execution of Tiziana's development strategy, investors should recognize this remains an intermediate step in the regulatory pathway. The involvement of multiple prestigious research centers suggests confidence in the approach, but definitive efficacy data will only come with trial completion.
The commencement of patient dosing at Yale for Tiziana's intranasal foralumab trial addresses a critical gap in Multiple Sclerosis treatment. Non-active Secondary Progressive MS (na-SPMS) represents one of the most challenging MS subtypes to treat effectively, with few approved therapies that meaningfully slow progression.
The innovative aspect here is the intranasal delivery method of foralumab, which may allow this fully human anti-CD3 monoclonal antibody to cross the blood-brain barrier more effectively than traditional administration routes. This could potentially enable direct modulation of the central nervous system immune response while potentially minimizing systemic side effects often associated with immunomodulatory therapies.
The trial's focus on microglial activation is scientifically sound, as these resident immune cells of the central nervous system play a crucial role in MS pathology. Chronic microglial activation contributes significantly to the neurodegenerative processes that drive disability progression in SPMS patients.
The double-blinded, placebo-controlled design across multiple academic centers strengthens the trial's scientific rigor. The inclusion of brain PET imaging allows for objective assessment of neuroinflammation, providing mechanistic insights beyond standard clinical measures. If successful, this approach could represent a paradigm shift in how we address progressive forms of MS, for which effective treatments remain an urgent unmet need.
NEW YORK, March 25, 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 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.
This Phase 2 trial aims to assess the safety, tolerability, and foralumab’s effect on microglial activation in patients with na-SPMS. Intranasal foralumab offers a novel approach to potentially mitigate the progression of SPMS. This multicenter study is important because it combines brain PET imaging, immunology, and measures of clinical evidence accepted by FDA.
"We are pleased to announce dosing at Yale in our multicenter Phase 2 trial, marking an important milestone in our efforts to address the unmet medical needs of patients with non-active SPMS," said William Clementi, PharmD, Chief Development Officer of Tiziana Life Sciences. "This trial represents a significant milestone in our clinical development program for intranasal foralumab and underscores our commitment to advancing innovative treatments and immune based approaches for autoimmune diseases."
The double blinded, multicenter placebo-controlled Phase 2 trial is expected to be completed by the end of 2025, with all participants, including those initially randomized to receive placebo during the blinded phase, having the opportunity to continue to participate in a further 6-month open-label extension (OLE) study. The OLE phase aims to further evaluate the long-term safety, tolerability, and durable effectiveness of foralumab in a larger number of patients.
Clinical site investigator at Yale University, Dr. Erin Longbrake, MD, PhD, Associate Professor of Neurology at Yale School of Medicine, commented, "The initiation of dosing in this trial marks an exciting advancement in our understanding and potential treatment of non-active SPMS. We look forward to contributing to the clinical evidence base for foralumab and its potential benefits for patients with this challenging condition."
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. The FDA has allowed an additional 20 patients to be enrolled in this EA program. 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).
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for 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
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