Tiziana Announces Reduction of Side Effects Commonly Seen with Discontinuation of GLP-1 Agonists with Nasal Anti-CD3
Tiziana Life Sciences (Nasdaq: TLSA) has announced promising findings regarding its nasal anti-CD3 monoclonal antibody, which mitigates side effects associated with the discontinuation of GLP-1 agonists. These drugs, used for treating metabolic disorders, often lead to side effects like muscle and bone loss, causing patients to stop treatment and lose the benefits of tissue homeostasis. Tiziana's therapy not only enhances the positive effects of semaglutide, a GLP-1 agonist but also sustains these benefits even after discontinuation.
Dr. Howard Weiner highlighted that nasal anti-CD3 provides a novel and non-toxic method for maintaining tissue homeostasis and improving patient outcomes. Researcher Selma Boulenouar PhD, noted that the therapy sustains tissue homeostasis and mitigates inflammation in key organs, including adipose tissue, liver, kidneys, and brain, even on a high-fat diet. The therapy's efficacy is attributed to its ability to induce regulatory T cells, which reduce tissue inflammation.
CEO Ivor Elrifi emphasized that these findings represent a significant advancement in treating metabolic and age-related diseases by maximizing the therapeutic benefits of GLP-1 drugs while minimizing associated risks.
Tiziana Life Sciences (Nasdaq: TLSA) ha annunciato risultati promettenti riguardo il suo anticorpo monoclonale anti-CD3 nasale, che mitiga gli effetti collaterali associati alla sospensione degli agonisti GLP-1. Questi farmaci, utilizzati per trattare i disturbi metabolici, spesso portano a effetti collaterali come la perdita di muscolo e osso, inducendo i pazienti a interrompere il trattamento e a perdere i benefici dell'omeostasi tissutale. La terapia di Tiziana non solo potenzia gli effetti positivi del semaglutide, un agonista GLP-1, ma mantiene anche questi benefici anche dopo la sospensione.
Il Dr. Howard Weiner ha sottolineato che l'anti-CD3 nasale offre un metodo nuovo e non tossico per mantenere l'omeostasi tissutale e migliorare gli esiti dei pazienti. La ricercatrice Selma Boulenouar PhD ha osservato che la terapia sostiene l'omeostasi tissutale e mitiga l'infiammazione in organi chiave, inclusi il tessuto adiposo, il fegato, i reni e il cervello, anche in una dieta ad alta percentuale di grassi. L'efficacia della terapia è attribuita alla sua capacità di indurre cellule T regolatorie, che riducono l'infiammazione tissutale.
Il CEO Ivor Elrifi ha enfatizzato che questi risultati rappresentano un'importante avanzamento nel trattamento delle malattie metaboliche e legate all'età, massimizzando i benefici terapeutici dei farmaci GLP-1 mentre si minimizzano i rischi associati.
Tiziana Life Sciences (Nasdaq: TLSA) ha anunciado hallazgos prometedores sobre su anticuerpo monoclonal anti-CD3 nasal, que mitiga los efectos secundarios asociados a la discontinuación de los agonistas GLP-1. Estos medicamentos, utilizados para tratar trastornos metabólicos, a menudo conducen a efectos secundarios como pérdida de masa muscular y ósea, lo que hace que los pacientes interrumpan el tratamiento y pierdan los beneficios de la homeostasis de los tejidos. La terapia de Tiziana no solo mejora los efectos positivos del semaglutide, un agonista GLP-1, sino que también mantiene estos beneficios incluso después de la discontinuación.
El Dr. Howard Weiner destacó que el anti-CD3 nasal proporciona un método novedoso y no tóxico para mantener la homeostasis de los tejidos y mejorar los resultados en los pacientes. La investigadora Selma Boulenouar PhD señaló que la terapia sostiene la homeostasis de los tejidos y mitiga la inflamación en órganos clave, incluyendo el tejido adiposo, el hígado, los riñones y el cerebro, incluso en una dieta alta en grasas. La eficacia de la terapia se atribuye a su capacidad para inducir células T reguladoras, que reducen la inflamación de los tejidos.
El CEO Ivor Elrifi enfatizó que estos hallazgos representan un avance significativo en el tratamiento de enfermedades metabólicas y relacionadas con la edad, maximizando los beneficios terapéuticos de los medicamentos GLP-1 mientras se minimizan los riesgos asociados.
티지아나 라이프 사이언스(Tiziana Life Sciences, 나스닥: TLSA)는 GLP-1 작용제의 중단과 관련된 부작용을 완화하는 비강용 항-CD3 단일클론 항체에 대한 유망한 결과를 발표했습니다. 이 약물은 대사 장애를 치료하는 데 사용되며, 종종 근육과 뼈 손실과 같은 부작용을 초래하여 환자가 치료를 중단하고 조직 항상성의 이점을 잃게 만듭니다. 티지아나의 치료법은 GLP-1 작용제인 세마글루타이드의 긍정적인 효과를 향상시킬 뿐만 아니라 중단 후에도 이러한 이점을 지속시킵니다.
하워드 와이너 박사는 비강용 항-CD3가 조직 항상성을 유지하고 환자 결과를 개선하는 새로운 비독성 방법을 제공한다고 강조했습니다. 연구원 셀마 부레누아르 박사는 이 치료가 지방조직, 간, 신장 및 뇌를 포함한 주요 장기에서 조직 항상성을 유지하고 염증을 완화한다고 언급했으며, 이는 고지방 식이에서도 가능합니다. 이 치료의 효능은 조직 염증을 줄이는 조절 T 세포를 유도하는 능력 덕분입니다.
CEO 아이버 엘리피는 이러한 발견이 GLP-1 약물의 치료적 이점을 극대화하면서 관련 위험을 최소화하는 대사 및 노화 관련 질병 치료에서 중요한 발전을 나타낸다고 강조했습니다.
Tiziana Life Sciences (Nasdaq: TLSA) a annoncé des résultats prometteurs concernant son anticorps monoclonal anti-CD3 nasal, qui atténue les effets secondaires associés à l'arrêt des agonistes GLP-1. Ces médicaments, utilisés pour traiter les troubles métaboliques, entraînent souvent des effets secondaires tels que la perte musculaire et osseuse, incitant les patients à interrompre le traitement et à perdre les bienfaits de l'homéostasie tissulaire. La thérapie de Tiziana non seulement renforce les effets positifs du sémaglutide, un agoniste GLP-1, mais maintient également ces avantages même après l'arrêt du traitement.
Le Dr. Howard Weiner a souligné que l'anti-CD3 nasal offre une méthode nouvelle et non toxique pour maintenir l'homéostasie tissulaire et améliorer les résultats des patients. La chercheuse Selma Boulenouar, PhD, a noté que la thérapie soutient l'homéostasie tissulaire et atténue l'inflammation dans des organes clés, y compris le tissu adipeux, le foie, les reins et le cerveau, même avec un régime riche en graisses. L'efficacité de la thérapie est attribuée à sa capacité à induire des cellules T régulatrices, qui réduisent l'inflammation tissulaire.
Le PDG Ivor Elrifi a souligné que ces résultats représentent une avancée significative dans le traitement des maladies métaboliques et liées à l'âge, en maximisant les bénéfices thérapeutiques des médicaments GLP-1 tout en minimisant les risques associés.
Tiziana Life Sciences (Nasdaq: TLSA) hat vielversprechende Ergebnisse zu seinem nasalen Anti-CD3-Monoklonalen Antikörper angekündigt, der Nebenwirkungen im Zusammenhang mit der Absetzung von GLP-1-Agonisten mildert. Diese Medikamente, die zur Behandlung von Stoffwechselerkrankungen eingesetzt werden, führen oft zu Nebenwirkungen wie Muskel- und Knochenschwund, wodurch Patienten die Behandlung absetzen und die Vorteile der Gewebe-Homöostase verlieren. Die Therapie von Tiziana verbessert nicht nur die positiven Effekte von Semaglutid, einem GLP-1-Agonisten, sondern hält diese Vorteile auch nach der Absetzung aufrecht.
Dr. Howard Weiner hob hervor, dass das nasale Anti-CD3 eine neuartige und nicht-toxische Methode bietet, um die Gewebe-Homöostase aufrechtzuerhalten und die Patientenergebnisse zu verbessern. Die Forscherin Selma Boulenouar PhD bemerkte, dass die Therapie die Gewebe-Homöostase unterstützt und Entzündungen in wichtigen Organen, einschließlich Fettgewebe, Leber, Nieren und Gehirn, selbst bei einer fettreichen Ernährung mindert. Die Wirksamkeit der Therapie wird ihrer Fähigkeit zugeschrieben, regulatorische T-Zellen zu induzieren, die die Gewebeentzündung reduzieren.
CEO Ivor Elrifi betonte, dass diese Ergebnisse einen bedeutenden Fortschritt bei der Behandlung von Stoffwechsel- und altersbedingten Erkrankungen darstellen, indem die therapeutischen Vorteile von GLP-1-Arzneimitteln maximiert und die damit verbundenen Risiken minimiert werden.
- Tiziana's nasal anti-CD3 therapy enhances and sustains the positive effects of GLP-1 agonists, even after discontinuation.
- The therapy mitigates side effects like muscle and bone loss, improving patient outcomes.
- Nasal anti-CD3 sustains tissue homeostasis and mitigates inflammation in key organs, independent of dietary changes.
- The therapy provides a non-toxic method for maintaining long-term metabolic health.
- None.
Insights
The discovery that nasal anti-CD3 can mitigate GLP-1 discontinuation effects represents a significant breakthrough in metabolic disorder treatment. The data suggesting sustained tissue homeostasis even after GLP-1 discontinuation addresses a critical market gap, as GLP-1 drugs like Ozempic and Wegovy often face adherence challenges due to side effects. The mechanism of action through regulatory T cell induction provides a scientifically sound basis for long-term efficacy.
The potential synergy with semaglutide could position TLSA's foralumab as a complementary therapy to the
This development could significantly impact Tiziana's market position and valuation. With a relatively small market cap of
Key value drivers include:
- Potential partnership opportunities with major GLP-1 manufacturers
- Expanded market access in the metabolic disorder space
- Differentiated product profile addressing unmet medical needs
The timing of this announcement is strategically significant given the explosive growth of the GLP-1 market. With major players like Novo Nordisk and Eli Lilly dominating the space, Tiziana's complementary approach could capture substantial market share without directly competing with these giants. The ability to reduce discontinuation side effects addresses a critical market need, as current GLP-1 discontinuation rates range from
The therapeutic potential in maintaining tissue homeostasis while on high-fat diets suggests broader applications beyond just GLP-1 complement therapy, potentially expanding the addressable market significantly.
NEW YORK, Jan. 10, 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 findings on the prolonged benefits of its nasal anti-CD3 monoclonal antibody in sustaining tissue homeostasis and mitigating the side effects associated with GLP-1 agonists discontinuation. This advancement offers a promising approach to overcoming the tolerability challenges and adverse effects commonly linked to prolonged GLP-1 drug use.
GLP-1 drugs, widely used for treating metabolic disorders, often face issues with long term tolerability, leading to side effects such as sarcopenia and bone density loss. These complications frequently result in the discontinuation of GLP-1 therapies, reversing their beneficial effects on tissue homeostasis. Tiziana’s nasal anti-CD3 therapy has been shown not only to enhance the positive effects of semaglutide, a GLP-1 agonist marketed by Novo Nordisk under the brand names Ozempic and Wegovy when administered together but now to potentially sustain these effects after a GLP-1’s discontinuation.
“One of the key challenges with GLP-1 drugs is their lack of tolerability over time, which can lead to adverse effects like muscle and bone loss,” said Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system. “Our research demonstrates that nasal anti-CD3 not only amplifies the beneficial effects of GLP-1 agonists but now also would potentially sustains these benefits even after discontinuation, providing a novel and non-toxic approach to maintaining tissue homeostasis and improving patient outcomes.”
Researcher, Selma Boulenouar PhD, elaborated on the findings: “Our data shows that even when on a high-fat diet, nasal anti-CD3 therapy sustains tissue homeostasis and mitigates inflammation in key organs, including adipose tissue, liver, kidneys, and brain. Importantly, the prolonged effects of nasal anti-CD3 are independent of dietary changes, making it a robust and versatile therapy for long-term metabolic health.”
The mechanism behind nasal anti-CD3’s efficacy lies in its ability to induce regulatory T cells, which dampen tissue inflammation and promote homeostasis. This discovery opens a new avenue for maintaining the positive effects of GLP-1 agonists, even in cases where discontinuation is necessary due to side effects or other factors.
“These findings are a pivotal step forward in the treatment of metabolic disorders and age-related diseases,” added Tiziana’s CEO, Ivor Elrifi. “Nasal anti-CD3 provides a unique opportunity to maximize and sustain the therapeutic benefits of GLP-1 drugs while mitigating their associated risks, ensuring long-term health and improved outcomes for patients.”
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 with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently 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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