CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
CytoDyn (OTCQB: CYDY) has announced significant results from three preclinical studies conducted with SMC Laboratories, demonstrating that leronlimab, their CCR5 antagonist drug, achieved statistically significant reversal of liver fibrosis in monotherapy (p-values < 0.01 vs control). Two studies completed in late 2024 evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis, while a third study concluded in January 2025 assessed liver fibrosis reversal using carbon tetrachloride.
Dr. Melissa Palmer, the Company's Lead Consultant in Hepatology, emphasized the significant unmet need in hepatology for managing advanced liver fibrosis. The company is exploring partnership opportunities to advance leronlimab's clinical development for treating fibrosis in the liver and potentially other organs, while maintaining focus on its 2025 oncology objectives.
CytoDyn (OTCQB: CYDY) ha annunciato risultati significativi da tre studi preclinici condotti con SMC Laboratories, dimostrando che leronlimab, il loro farmaco antagonista CCR5, ha ottenuto una significativa inversione della fibrosi epatica in monoterapia (valori p < 0,01 rispetto al controllo). Due studi completati alla fine del 2024 hanno valutato leronlimab nel modello STAM™ di disfunzione metabolica associata alla steatoepatite (MASH) con fibrosi, mentre un terzo studio concluso a gennaio 2025 ha valutato l'inversione della fibrosi epatica utilizzando il tetracloruro di carbonio.
La Dott.ssa Melissa Palmer, la consulente principale della società in epatologia, ha sottolineato l'importante bisogno insoddisfatto in epatologia per la gestione della fibrosi epatica avanzata. L'azienda sta esplorando opportunità di partnership per avanzare lo sviluppo clinico di leronlimab per il trattamento della fibrosi nel fegato e potenzialmente in altri organi, mantenendo al contempo l'attenzione sui suoi obiettivi oncologici del 2025.
CytoDyn (OTCQB: CYDY) ha anunciado resultados significativos de tres estudios preclínicos realizados con SMC Laboratories, demostrando que leronlimab, su medicamento antagonista CCR5, logró una inversión estadísticamente significativa de la fibrosis hepática en monoterapia (valores p < 0.01 frente al control). Dos estudios completados a finales de 2024 evaluaron leronlimab en el modelo STAM™ de disfunción metabólica asociada a la esteatohepatitis (MASH) con fibrosis, mientras que un tercer estudio concluyó en enero de 2025 evaluando la reversión de la fibrosis hepática utilizando tetracloruro de carbono.
La Dra. Melissa Palmer, consultora principal de la compañía en hepatología, enfatizó la importante necesidad no satisfecha en hepatología para el manejo de la fibrosis hepática avanzada. La compañía está explorando oportunidades de asociación para avanzar en el desarrollo clínico de leronlimab para el tratamiento de la fibrosis en el hígado y potencialmente en otros órganos, manteniendo al mismo tiempo el enfoque en sus objetivos oncológicos para 2025.
CytoDyn (OTCQB: CYDY)는 SMC Laboratories와 진행한 세 가지 전임상 연구에서 중요한 결과를 발표하였으며, 그들의 CCR5 길항제 약물인 leronlimab이 단독 요법에서 간 섬유증을 통계적으로 유의미하게 역전시켰음을 보여주었습니다(대조군에 비해 p-값 < 0.01). 2024년 말에 완료된 두 가지 연구는 섬유증이 동반된 대사 기능 장애와 관련된 스테아토헤파티티(STAM™) 모델에서 leronlimab을 평가했으며, 세 번째 연구는 2025년 1월에 탄소 테트라클로라이드를 사용하여 간 섬유증 역전을 평가했습니다.
회사의 간질환 분야 수석 고문인 멜리사 팔머 박사는 간 섬유증 관리에 대한 중요한 unmet need를 강조했습니다. 이 회사는 간 섬유증 및 잠재적으로 다른 장기 치료를 위한 leronlimab의 임상 개발을 진전시키기 위해 파트너십 기회를 탐색하고 있으며, 동시에 2025년 종양학 목표에 집중하고 있습니다.
CytoDyn (OTCQB: CYDY) a annoncé des résultats significatifs issus de trois études précliniques réalisées avec SMC Laboratories, démontrant que le leronlimab, leur médicament antagoniste CCR5, a réussi à provoquer une inversion statistiquement significative de la fibrose hépatique en monothérapie (valeurs p < 0,01 par rapport au contrôle). Deux études terminées fin 2024 ont évalué le leronlimab dans le modèle STAM™ de dysfonction métabolique associée à la stéato-hépatite (MASH) avec fibrose, tandis qu'une troisième étude conclue en janvier 2025 a évalué l'inversion de la fibrose hépatique à l'aide de tétrachlorure de carbone.
Dr. Melissa Palmer, la consultante principale de la société en hépatologie, a souligné le besoin important non satisfait en hépatologie pour la gestion de la fibrose hépatique avancée. L'entreprise explore les opportunités de partenariat pour faire avancer le développement clinique du leronlimab pour le traitement de la fibrose dans le foie et potentiellement dans d'autres organes, tout en maintenant son attention sur ses objectifs en oncologie pour 2025.
CytoDyn (OTCQB: CYDY) hat bedeutende Ergebnisse aus drei präklinischen Studien, die mit SMC Laboratories durchgeführt wurden, vorgestellt. Diese zeigten, dass leronlimab, ihr CCR5-Antagonisten-Medikament, eine statistisch signifikante Rückbildung der Leberfibrose in Monotherapie erzielte (p-Werte < 0,01 im Vergleich zur Kontrolle). Zwei Studien, die Ende 2024 abgeschlossen wurden, bewerteten leronlimab im STAM™-Modell der mit Fibrose verbundenen metabolischen Dysfunktion, während eine dritte Studie im Januar 2025 die Rückbildung der Leberfibrose mit Tetrachlorkohlenstoff untersuchte.
Dr. Melissa Palmer, die leitende Beraterin des Unternehmens in der Hepatologie, betonte den erheblichen ungedeckten Bedarf in der Hepatologie zur Behandlung fortgeschrittener Leberfibrose. Das Unternehmen untersucht Partnerschaftsmöglichkeiten, um die klinische Entwicklung von leronlimab zur Behandlung von Fibrose in der Leber und möglicherweise in anderen Organen voranzutreiben, während es gleichzeitig auf seine Onkologiem Ziele für 2025 konzentriert bleibt.
- Achieved statistically significant liver fibrosis reversal in three preclinical studies (p < 0.01)
- Demonstrated potential for multiple therapeutic applications beyond liver fibrosis
- Positive results in both MASH model and carbon tetrachloride-induced fibrosis
- Still in preclinical stage, requiring extensive clinical trials before commercialization
- Company needs partnerships to advance development, indicating potential resource constraints
VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories (“SMC”).
The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35.
“The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology.
Dr. Jacob Lalezari, CEO of CytoDyn, added, “We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab’s core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions. As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart.”
CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings. The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs.
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, oncology, and autoimmune conditions.
About SMC Laboratories
SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media Contacts
CytoDyn Inc.
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FAQ
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