Tiziana Life Sciences Announces Johns Hopkins University Commences Dosing Nasal Foralumab in Phase 2 Multiple Sclerosis Clinical Trial
Tiziana Life Sciences (Nasdaq: TLSA) has announced the commencement of dosing at Johns Hopkins University (JHU), the third clinical site in its Phase 2 trial of intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The trial, also conducted at Brigham and Women's Hospital and MS Center at Yale Medical Center, is a randomized, double-blind, placebo-controlled study.
The trial aims to evaluate the safety, tolerability, and efficacy of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, in na-SPMS patients who experience progressive neurological decline without relapses. The blinded portion is expected to complete by end of 2025, followed by a six-month open-label extension period where all participants can receive the treatment.
Tiziana Life Sciences (Nasdaq: TLSA) ha annunciato l'inizio della somministrazione presso Johns Hopkins University (JHU), il terzo sito clinico nel suo studio di Fase 2 sull'uso intranasale di foralumab per la Sclerosi Multipla Secondaria Progressiva non attiva (na-SPMS). Lo studio, condotto anche presso il Brigham and Women's Hospital e il MS Center del Yale Medical Center, è un trial randomizzato, in doppio cieco e controllato con placebo.
Lo scopo dello studio è valutare la sicurezza, la tollerabilità e l'efficacia di foralumab intranasale, un anticorpo monoclonale anti-CD3 completamente umano, in pazienti con na-SPMS che presentano un declino neurologico progressivo senza riacutizzazioni. La parte in cieco dovrebbe concludersi entro la fine del 2025, seguita da un periodo di estensione in aperto di sei mesi in cui tutti i partecipanti potranno ricevere il trattamento.
Tiziana Life Sciences (Nasdaq: TLSA) ha anunciado el inicio de la dosificación en Johns Hopkins University (JHU), el tercer sitio clínico en su ensayo de Fase 2 de foralumab intranasal para la Esclerosis Múltiple Secundaria Progresiva no activa (na-SPMS). El ensayo, que también se lleva a cabo en el Brigham and Women's Hospital y en el MS Center del Yale Medical Center, es un estudio aleatorizado, doble ciego y controlado con placebo.
El ensayo tiene como objetivo evaluar la seguridad, la tolerabilidad y la eficacia de foralumab intranasal, un anticuerpo monoclonal anti-CD3 completamente humano, en pacientes con na-SPMS que experimentan un deterioro neurológico progresivo sin recaídas. Se espera que la parte ciega se complete a finales de 2025, seguida de un período de extensión abierto de seis meses en el que todos los participantes podrán recibir el tratamiento.
티지아나 라이프 사이언스 (Nasdaq: TLSA)는 존스 홉킨스 대학교 (JHU)에서 비활성 2차 진행형 다발성 경화증(na-SPMS)을 위한 비강 내 포랄루맙의 2상 시험에서 세 번째 임상 사이트에서 투약을 시작한다고 발표했습니다. 이 시험은 브리검 여성 병원과 예일 의대 MS 센터에서도 진행되며, 무작위 이중 맹검 위약 대조 연구입니다.
이 시험의 목적은 재발 없이 진행성 신경학적 감소를 경험하는 na-SPMS 환자에서 비강 내 포랄루맙, 완전 인간 anti-CD3 단클론 항체의 안전성, 내약성 및 유효성을 평가하는 것입니다. 맹검 부분은 2025년 말까지 완료될 것으로 예상되며, 모든 참가자가 치료를 받을 수 있는 6개월의 공개 연장 기간이 이어집니다.
Tiziana Life Sciences (Nasdaq: TLSA) a annoncé le début de l'administration à l'Université Johns Hopkins (JHU), le troisième site clinique de son essai de Phase 2 sur le foralumab intranasal pour la Sclérose en Plaques Secondaire Progressive non active (na-SPMS). L'essai, également mené au Brigham and Women's Hospital et au MS Center du Yale Medical Center, est une étude randomisée, en double aveugle et contrôlée par placebo.
L'objectif de l'essai est d'évaluer la sécurité, la tolérabilité et l'efficacité du foralumab intranasal, un anticorps monoclonal anti-CD3 entièrement humain, chez des patients na-SPMS qui connaissent un déclin neurologique progressif sans rechutes. La partie en aveugle devrait se terminer d'ici la fin de 2025, suivie d'une période d'extension ouverte de six mois au cours de laquelle tous les participants pourront recevoir le traitement.
Tiziana Life Sciences (Nasdaq: TLSA) hat den Beginn der Dosierung an der Johns Hopkins University (JHU) angekündigt, dem dritten klinischen Standort in ihrer Phase-2-Studie zu intranasalem Foralumab bei nicht aktiver sekundärer progressiver Multipler Sklerose (na-SPMS). Die Studie, die auch im Brigham and Women's Hospital und im MS Center des Yale Medical Centers durchgeführt wird, ist eine randomisierte, doppelblinde, placebokontrollierte Studie.
Das Ziel der Studie ist es, die Sicherheit, Verträglichkeit und Wirksamkeit von intranasalem Foralumab, einem vollständig menschlichen anti-CD3-Monoklonalen Antikörper, bei na-SPMS-Patienten zu bewerten, die einen progressiven neurologischen Rückgang ohne Rückfälle erleben. Der blind durchgeführte Teil soll bis Ende 2025 abgeschlossen sein, gefolgt von einer sechsmonatigen offenen Verlängerungsphase, in der alle Teilnehmer die Behandlung erhalten können.
- Expansion to third major clinical site (Johns Hopkins) increases trial reach and credibility
- Trial addresses an underserved market with treatment options
- Structured timeline with completion expected by end of 2025
- Results and efficacy data not yet available
- Long timeline to completion (end of 2025) before potential commercialization
Insights
Tiziana's announcement about commencing dosing at Johns Hopkins University marks a meaningful advancement in their Phase 2 clinical program for intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Adding this third prestigious institution alongside Brigham and Women's Hospital and Yale Medical Center strengthens the trial's credibility and should facilitate patient recruitment.
The significance of this development stems from several factors. First, na-SPMS represents a critical unmet medical need with treatment options currently available. The condition is characterized by progressive neurological decline without relapses, making it particularly challenging to treat with existing therapies.
Intranasal foralumab's mechanism as a fully human anti-CD3 monoclonal antibody with the potential to modulate compartmentalized neuroinflammation represents an innovative approach. The intranasal delivery method may offer advantages by targeting the central nervous system while potentially reducing systemic side effects common with immunomodulatory treatments.
The company's timeline projection of completing the blinded portion by end-2025 provides investors with clear expectations. The subsequent six-month open-label extension will generate additional safety and efficacy data while offering treatment access to placebo group participants.
For Tiziana, expanding this trial demonstrates operational execution and continued progress of their lead development candidate. While this update doesn't provide efficacy data, it confirms that the clinical program continues to advance as planned, which is particularly important for smaller biotechnology companies advancing novel therapeutic approaches.
NEW YORK, April 02, 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 has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2 trial evaluating intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Other active clinical sites in the study include Brigham and Women’s Hospital (BWH) and MS Center at Yale Medical Center.
The randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and efficacy of intranasal foralumab in patients with na-SPMS, a form of multiple sclerosis (MS) characterized by progressive neurological decline without relapses.
Dr. Pavan Bhargava, MD, Associate Professor of Neurology and principal investigator at JHU, emphasized the importance of advancing novel treatments for na-SPMS: “Patients with non-active SPMS currently have limited treatment options, and there is an urgent need for therapies that can modulate compartmentalized neuroinflammation and potentially slow disease progression. We are excited to participate in this clinical trial and explore the potential benefits of foralumab in this underserved population.”
“The addition of Johns Hopkins University to our Phase 2 trial to is a significant milestone in our mission to develop a novel approaches and treatment for na-SPMS.” Commented William A. Clementi, PharmD, Chief Development Officer of Tiziana Life Sciences. “Intranasal foralumab has demonstrated promising potential in modulating the immune system to reduce neuroinflammation, and we are eager to continue advancing this study to provide new hope for patients facing this disabling condition.”
Tiziana expects the blinded portion of the trial to be completed by the end of 2025. Following this phase, all participants, including those who initially received a placebo, will have the opportunity to enter a six-month open-label extension (OLE) period. This phase will allow further evaluation of the safety, tolerability, and efficacy of intranasal foralumab in a broader patient population.
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, stated: “Our commitment to innovation in neurodegenerative disease treatment is reinforced by the expansion of this trial to a third major clinical trial site. We believe intranasal foralumab represents a paradigm shift in addressing non-active Secondary Progressive MS, and we remain dedicated to advancing its development to benefit patients in need.”
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 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.
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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