Tiziana Life Sciences Announces Long Covid Study to Complete in Second Quarter
Tiziana Life Sciences (Nasdaq: TLSA) announced that a nasal anti-CD3 (foralumab) preclinical study for Long COVID is nearing completion in the second quarter of 2025. Foralumab, a fully human anti-CD3 monoclonal antibody, could offer a novel treatment for Long COVID by reducing microglial activation, which contributes to persistent brain inflammation associated with the condition.
Long COVID affects millions worldwide with symptoms including fatigue, cognitive impairment ("brain fog"), and psychiatric issues like depression. PET imaging studies confirm increased microglial activity in Long COVID patients, highlighting the need for targeted therapies.
Previously, Tiziana conducted a human clinical study where foralumab was nasally administered to COVID-19 patients for 10 consecutive days, showing good tolerability and significant reduction in lung inflammation. The company's nasal anti-CD3 platform has also demonstrated efficacy in reducing microglial activation in models of multiple sclerosis and Alzheimer's Disease.
Tiziana Life Sciences (Nasdaq: TLSA) ha annunciato che uno studio preclinico sull'anti-CD3 nasale (foralumab) per il Long COVID è vicino al completamento nel secondo trimestre del 2025. Foralumab, un anticorpo monoclonale anti-CD3 completamente umano, potrebbe offrire un nuovo trattamento per il Long COVID riducendo l'attivazione microgliale, che contribuisce all'infiammazione cerebrale persistente associata alla condizione.
Il Long COVID colpisce milioni di persone in tutto il mondo con sintomi che includono affaticamento, compromissione cognitiva (
Tiziana Life Sciences (Nasdaq: TLSA) anunció que un estudio preclínico de un anti-CD3 nasal (foralumab) para el Long COVID está cerca de completarse en el segundo trimestre de 2025. Foralumab, un anticuerpo monoclonal anti-CD3 completamente humano, podría ofrecer un nuevo tratamiento para el Long COVID al reducir la activación microglial, que contribuye a la inflamación cerebral persistente asociada con la condición.
El Long COVID afecta a millones de personas en todo el mundo con síntomas que incluyen fatiga, deterioro cognitivo ("niebla mental") y problemas psiquiátricos como la depresión. Los estudios de imagen PET confirman una actividad microglial aumentada en pacientes con Long COVID, destacando la necesidad de terapias específicas.
Anteriormente, Tiziana llevó a cabo un estudio clínico en humanos donde se administró foralumab por vía nasal a pacientes con COVID-19 durante 10 días consecutivos, mostrando buena tolerabilidad y una reducción significativa de la inflamación pulmonar. La plataforma anti-CD3 nasal de la empresa también ha demostrado eficacia en la reducción de la activación microglial en modelos de esclerosis múltiple y enfermedad de Alzheimer.
티지아나 라이프 사이언스 (Nasdaq: TLSA)는 롱 COVID를 위한 비강 항-CD3 (포랄루맙) 전임상 연구가 2025년 2분기에 완료될 예정이라고 발표했습니다. 포랄루맙은 완전 인간 항-CD3 단클론 항체로, 미세아교세포 활성화 감소를 통해 롱 COVID에 대한 새로운 치료법을 제공할 수 있습니다. 이는 이 질환과 관련된 지속적인 뇌 염증에 기여합니다.
롱 COVID는 전 세계 수백만 명에게 영향을 미치며, 증상으로는 피로, 인지 장애(“브레인 포그”) 및 우울증과 같은 정신과적 문제가 포함됩니다. PET 이미징 연구는 롱 COVID 환자에서 미세아교세포 활동 증가를 확인하며, 표적 치료의 필요성을 강조합니다.
이전에 티지아나는 포랄루맙을 COVID-19 환자에게 10일 연속으로 비강 투여하는 인간 임상 연구를 수행했으며, 좋은 내약성과 폐 염증의 유의미한 감소를 보여주었습니다. 회사의 비강 항-CD3 플랫폼은 다발성 경화증 및 알츠하이머병 모델에서도 미세아교세포 활성화를 줄이는 효과를 입증했습니다.
Tiziana Life Sciences (Nasdaq: TLSA) a annoncé qu'une étude préclinique sur un anti-CD3 nasal (foralumab) pour le Long COVID est sur le point d'être achevée au deuxième trimestre de 2025. Le foralumab, un anticorps monoclonal anti-CD3 entièrement humain, pourrait offrir un nouveau traitement pour le Long COVID en réduisant l'activation microgliale, qui contribue à l'inflammation cérébrale persistante associée à cette condition.
Le Long COVID touche des millions de personnes dans le monde avec des symptômes tels que la fatigue, des troubles cognitifs ("brouillard cérébral") et des problèmes psychiatriques comme la dépression. Des études d'imagerie par PET confirment une activité microgliale accrue chez les patients atteints de Long COVID, soulignant le besoin de thérapies ciblées.
Auparavant, Tiziana a mené une étude clinique humaine où le foralumab a été administré par voie nasale à des patients COVID-19 pendant 10 jours consécutifs, montrant une bonne tolérance et une réduction significative de l'inflammation pulmonaire. La plateforme anti-CD3 nasale de l'entreprise a également démontré son efficacité dans la réduction de l'activation microgliale dans des modèles de sclérose en plaques et de maladie d'Alzheimer.
Tiziana Life Sciences (Nasdaq: TLSA) gab bekannt, dass eine präklinische Studie mit einem nasalen Anti-CD3 (Foralumab) für Long COVID im zweiten Quartal 2025 kurz vor dem Abschluss steht. Foralumab, ein vollständig menschlicher Anti-CD3-Monoklonantikörper, könnte eine neuartige Behandlung für Long COVID bieten, indem es die Mikroglia-Aktivierung reduziert, die zur anhaltenden Gehirnentzündung beiträgt, die mit der Erkrankung verbunden ist.
Long COVID betrifft weltweit Millionen von Menschen mit Symptomen wie Müdigkeit, kognitiven Beeinträchtigungen ("Gehirnnebel") und psychiatrischen Problemen wie Depressionen. PET-Bildgebungsstudien bestätigen eine erhöhte Mikroglia-Aktivität bei Long COVID-Patienten und heben den Bedarf an zielgerichteten Therapien hervor.
Zuvor führte Tiziana eine klinische Studie mit Menschen durch, in der Foralumab über 10 aufeinanderfolgende Tage nasal an COVID-19-Patienten verabreicht wurde, wobei eine gute Verträglichkeit und eine signifikante Reduktion der Lungenentzündung gezeigt wurden. Die nasale Anti-CD3-Plattform des Unternehmens hat auch ihre Wirksamkeit bei der Reduzierung der Mikroglia-Aktivierung in Modellen von Multipler Sklerose und Alzheimer-Krankheit gezeigt.
- Foralumab preclinical study for Long COVID nearing completion in Q2 2025
- Previous clinical study showed foralumab was well-tolerated with significant reduction in lung inflammation
- Nasal anti-CD3 platform demonstrated efficacy in reducing microglial activation in MS and Alzheimer's models
- Potential novel treatment approach for millions suffering from Long COVID worldwide
- Only preclinical study results forthcoming, not yet advanced to later-stage trials
- No efficacy data specifically for Long COVID treatment yet available
- No revenue generation from this therapy in the near term
Insights
Tiziana Life Sciences' announcement about the imminent completion of its preclinical long COVID study represents a strategic expansion of its foralumab platform into a significant unmet medical need. While this news indicates pipeline progress, investors should understand the critical distinctions between the company's completed COVID-19 lung inflammation clinical study and this preclinical work targeting neurological long COVID symptoms.
The company's approach targeting microglial activation for long COVID symptoms is scientifically sound and leverages their existing technology platform. By repurposing foralumab for neurological long COVID symptoms, Tiziana is pursuing a capital-efficient strategy that could accelerate development timelines compared to novel compound discovery. Their prior positive safety data from the COVID-19 lung inflammation study provides a foundation for advancing this program.
For a micro-cap biotech with a market capitalization of approximately $89 million, this program represents a significant potential value driver if successful. The long COVID market remains largely underserved despite affecting an estimated 65 million people globally, with neuropsychiatric symptoms among the most debilitating and persistent.
Investors should watch for several near-term catalysts:
- Q2 2025 completion of the preclinical study
- Potential IND filing for a clinical trial in long COVID
- Cross-indication data supporting foralumab's mechanism in neuroinflammation
The company's parallel work in multiple sclerosis and Alzheimer's creates a diversified CNS portfolio with shared scientific underpinnings, potentially derisking the overall platform. However, this remains an early-stage program requiring substantial clinical validation before commercialization.
While promising, this announcement primarily signals continued progress rather than a definitive clinical breakthrough. The completion of preclinical work represents just one step in a lengthy development process, though Tiziana may benefit from an accelerated regulatory pathway given the public health significance of long COVID.
NEW YORK, Feb. 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 that a nasal anti-CD3 (foralumab) preclinical study is nearing completion, and that foralumab could offer a novel and effective treatment for long COVID. This innovative approach works by reducing microglial activation, a key factor in the persistent brain inflammation associated with long COVID, thereby addressing the debilitating neurological and psychiatric symptoms many patients face.
Long COVID is a complex and often debilitating complication following COVID-19 infection. It affects millions worldwide, presenting with symptoms such as persistent fatigue, cognitive impairment (“brain fog”), and psychiatric issues like depression. A growing body of evidence highlights that long COVID is linked to sustained brain inflammation and microglial activation, which disrupts normal brain function. PET imaging studies confirm increased microglial activity in individuals suffering from long COVID, underlining the urgent need for targeted therapies.
Previously, Tiziana conducted a human clinical study in patients with mild to moderate COVID-19 where foralumab was nasally administered once a day for 10 consecutive days. Treatment was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanning. The aim of the human study was to assess safety of intranasal Foralumab and evaluate its potential benefits in treating immune hyperactivity and lung inflammation who were outpatients at the Santa Casa de Misericordia de Santos Hospital in Brazil.
Tiziana’s nasal anti-CD3 platform has previously demonstrated efficacy in reducing microglial activation in models of central nervous system (CNS) diseases, including multiple sclerosis (MS) and Alzheimer’s Disease.
“Long COVID has challenged the medical community with its complexity, but targeting microglial activation through nasal anti-CD3 presents a promising therapeutic avenue,” commented Tiziana’s CEO, Ivor Elrifi. “A study in secondary progressive multiple sclerosis showed both clinical improvement and decreased microglial activation via TSPO PET imaging, providing a solid foundation for this Long COVID hypothesis. Importantly, nasal anti-CD3 was well tolerated, with no serious adverse events.”
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
When will Tiziana Life Sciences (TLSA) complete its Long COVID study?
How does TLSA's foralumab work to treat Long COVID symptoms?
What results did TLSA's previous foralumab trial show for COVID-19 patients?
What other conditions has TLSA's nasal anti-CD3 platform shown efficacy for besides Long COVID?
What are the main symptoms of Long COVID that TLSA's foralumab aims to address?
