CytoDyn Announces Preliminary Findings in Study with SMC Laboratories
CytoDyn Inc. (OTCQB: CYDY) has announced preliminary findings from a preclinical study conducted by SMC Laboratories on leronlimab, its CCR5 antagonist. The study assessed optimal dosing for MASH (Metabolic dysfunction-Associated Steatohepatitis) and potential synergies with Resmetirom. Key findings include:
1. Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to control (p<0.01).
2. Dose-dependent antifibrotic activity was observed, with 700 mg performing better than 350 mg.
3. Leronlimab (700 mg) appeared to have better anti-fibrotic activity than Resmetirom (p=0.057).
Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about the results, stating they confirm leronlimab's potential to benefit patients with various medical concerns. The company is in discussions with SMC Laboratories regarding next steps, including supplemental studies to expand on these findings and advance their clinical pipeline.
CytoDyn Inc. (OTCQB: CYDY) ha annunciato i risultati preliminari di uno studio preclinico condotto da SMC Laboratories su leronlimab, il suo antagonista CCR5. Lo studio ha valutato il dosaggio ottimale per MASH (Steatoepatite assoicata a disfunzione metabolica) e potenziali sinergie con Resmetirom. I risultati chiave includono:
1. La monoterapia con leronlimab (700 mg) ha mostrato una significativa reversibilità della fibrosi rispetto al gruppo di controllo (p<0.01).
2. È stata osservata un'attività antifibrotica dose-dipendente, con 700 mg che ha mostrato risultati migliori rispetto ai 350 mg.
3. Leronlimab (700 mg) sembra avere un'attività anti-fibrotica superiore rispetto a Resmetirom (p=0.057).
Il Dr. Jacob Lalezari, CEO di CytoDyn, ha espresso entusiasmo riguardo ai risultati, affermando che confermano il potenziale di leronlimab di beneficiare i pazienti con varie problematiche mediche. L'azienda è in discussioni con SMC Laboratories riguardo ai prossimi passi, tra cui studi supplementari per ampliare questi risultati e far avanzare il loro pipeline clinico.
CytoDyn Inc. (OTCQB: CYDY) ha anunciado hallazgos preliminares de un estudio preclínico realizado por SMC Laboratories sobre leronlimab, su antagonista CCR5. El estudio evaluó la dosificación óptima para MASH (Esteatohepatitis asociada a disfunción metabólica) y posibles sinergias con Resmetirom. Los hallazgos clave incluyen:
1. La monoterapia con leronlimab (700 mg) mostró una reversión de fibrosis estadísticamente significativa en comparación con el control (p<0.01).
2. Se observó actividad antifibrótica dependiente de la dosis, con 700 mg funcionando mejor que 350 mg.
3. Leronlimab (700 mg) pareció tener una mejor actividad antifibrótica que Resmetirom (p=0.057).
El Dr. Jacob Lalezari, CEO de CytoDyn, expresó su entusiasmo por los resultados, afirmando que confirman el potencial de leronlimab para beneficiar a pacientes con diversas preocupaciones médicas. La empresa está en discusiones con SMC Laboratories sobre los siguientes pasos, incluyendo estudios suplementarios para ampliar estos hallazgos y avanzar en su pipeline clínico.
CytoDyn Inc. (OTCQB: CYDY)는 SMC Laboratories가 수행한 leronlimab(그의 CCR5 길항제)에 대한 전임상 연구의 초기 결과를 발표했습니다. 이 연구는 MASH (대사 기능 장애 관련 지방간염)에 대한 최적의 용량과 Resmetirom과의 잠재적 시너지 효과를 평가했습니다. 주요 발견 사항은 다음과 같습니다:
1. Leronlimab 단독 요법(700 mg)은 대조군에 비해 통계적으로 유의한 섬유증 회복을 보여주었습니다 (p<0.01).
2. 용량 의존형 항섬유증 활성이 관찰되었으며, 700 mg이 350 mg보다 더 우수한 성능을 보였습니다.
3. Leronlimab (700 mg)은 Resmetirom보다 더 나은 항섬유증 활성을 보였습니다 (p=0.057).
CytoDyn의 CEO인 Jacob Lalezari 박사는 이 결과에 대해 흥분을 표하며, leronlimab가 다양한 의료 문제를 가진 환자들에게 이익이 될 가능성을 확인시켜 준다고 말했습니다. 회사는 SMC Laboratories와 다음 단계에 대해 논의 중이며, 이러한 결과를 확장하고 임상 파이프라인을 발전시키기 위한 보충 연구를 포함합니다.
CytoDyn Inc. (OTCQB: CYDY) a annoncé des résultats préliminaires d'une étude préclinique réalisée par SMC Laboratories sur leronlimab, son antagoniste CCR5. L'étude a évalué le dosage optimal pour MASH (Stéato-hépatite associée à une dysfonction métabolique) et les synergies potentielles avec Resmetirom. Les principales conclusions comprennent :
1. La monothérapie par leronlimab (700 mg) a montré une réversion significative de la fibrose par rapport au groupe témoin (p<0.01).
2. Une activité antifibrotique dépendante de la dose a été observée, avec 700 mg étant plus efficace que 350 mg.
3. Leronlimab (700 mg) semblait avoir une meilleure activité antifibrotique que Resmetirom (p=0.057).
Le Dr Jacob Lalezari, PDG de CytoDyn, a exprimé son enthousiasme quant aux résultats, déclarant qu'ils confirment le potentiel de leronlimab à bénéficier à des patients ayant divers problèmes de santé. L'entreprise est en discussion avec SMC Laboratories sur les prochaines étapes, y compris des études complémentaires pour approfondir ces résultats et faire avancer leur pipeline clinique.
CytoDyn Inc. (OTCQB: CYDY) hat vorläufige Ergebnisse einer von SMC Laboratories durchgeführten präklinischen Studie zu leronlimab, seinem CCR5-Antagonisten, bekannt gegeben. Die Studie bewertete die optimale Dosierung für MASH (Metabolismus-bedingte Steatohepatitis) und potenzielle Synergien mit Resmetirom. Zu den wichtigsten Ergebnissen gehören:
1. Die Monotherapie mit leronlimab (700 mg) zeigte im Vergleich zur Kontrolle eine statistisch signifikante Rückbildung der Fibrose (p<0.01).
2. Es wurde eine dosisabhängige antifibrotische Aktivität beobachtet, wobei 700 mg besser abschnitten als 350 mg.
3. Leronlimab (700 mg) schien eine bessere antifibrotische Aktivität zu haben als Resmetirom (p=0.057).
Dr. Jacob Lalezari, CEO von CytoDyn, äußerte sich begeistert über die Ergebnisse und erklärte, dass sie das Potenzial von Leronlimab bestätigen, Patienten mit verschiedenen medizinischen Anliegen zu helfen. Das Unternehmen befindet sich in Gesprächen mit SMC Laboratories über die nächsten Schritte, einschließlich zusätzlicher Studien zur Erweiterung dieser Ergebnisse und zur Weiterentwicklung ihrer klinischen Pipeline.
- Leronlimab (700 mg) demonstrated statistically significant fibrosis reversal compared to control
- Dose-dependent antifibrotic activity observed, with higher dose (700 mg) performing better
- Leronlimab (700 mg) showed better anti-fibrotic activity compared to the only currently approved MASH therapy, Resmetirom
- None.
VANCOUVER, Washington, Sept. 24, 2024 (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 a preliminary review of results from its preclinical study with SMC Laboratories.
SMC Laboratories, a company specializing in preclinical drug efficacy evaluations using various models of inflammation and fibrosis in mice, conducted a study that assessed the optimal dosing of leronlimab in the MASH setting and potential synergies with Resmetirom, the only currently approved therapy for the treatment of MASH. A preliminary review of the study results has led to several encouraging findings, as follows:
- Leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01);
- Leronlimab monotherapy appeared to demonstrate dose-dependent antifibrotic activity, with leronlimab 700 mg performing better at reversing liver fibrosis compared to leronlimab 350 mg; and
- Leronlimab monotherapy (700 mg) appears to have better anti-fibrotic activity compared to Resmetirom (p=0.057).
“These initial results are very exciting and confirm our belief that leronlimab has the potential to be materially beneficial for patients suffering from a number of medical concerns,” said Dr. Jacob Lalezari, CEO of CytoDyn. “While additional research is necessary to confirm and explore these findings further, we are very encouraged about the potential for leronlimab to support therapeutics meant to address MASH and specifically fibrosis and related complications in the liver.”
CytoDyn is in discussions with SMC Laboratories regarding next steps – including supplemental lab studies to expand on these promising findings, further explore potential synergies and continue to advance the Company’s clinical pipeline.
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.
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.
CONTACT
CytoDyn
Investor Relations
CytoDyn Inc.
ir@cytodyn.com
FAQ
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