ACELYRIN, INC. Announces Positive Proof-of-Concept Data From Phase 1/2 Clinical Trial of Lonigutamab as a Subcutaneous Treatment for Thyroid Eye Disease to be Presented at 42nd Annual Meeting of European Society of Ophthalmic Plastic and Reconstructive Surgery
ACELYRIN, INC. (Nasdaq: SLRN) announced positive data from its Phase 1/2 clinical trial of lonigutamab for thyroid eye disease (TED) will be presented at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery. The presentation, titled 'Preliminary Safety, Efficacy, and Quality of Life Outcomes of Subcutaneous Lonigutamab from a Phase 1/2 Proof of Concept Study in Patients with Thyroid Eye Disease,' will take place on September 14, 2024, in Rotterdam, Netherlands.
Dr. Jwu Jin Khong will deliver the rapid-fire oral presentation. ACELYRIN's Chief Medical Officer, Dr. Shephard Mpofu, highlighted the potential of lonigutamab to improve clinical outcomes through rapid suppression of IGF-1 receptor signaling, achieving robust responses with low drug exposures. The company believes the data supports the potential for subcutaneously-delivered lonigutamab to provide deep and durable responses with convenient, self-administered dosing.
ACELYRIN, INC. (Nasdaq: SLRN) ha annunciato dati positivi dal suo studio clinico di Fase 1/2 su lonigutamab per la malattia oculare tiroidea (TED), che saranno presentati al 42° Congresso Annuale della Società Europea di Chirurgia Oftalmoplastica e Ricostruttiva. La presentazione, intitolata 'Risultati Preliminari di Sicurezza, Efficacia e Qualità della Vita di Lonigutamab Sottocutaneo da uno Studio di Fase 1/2 di Prova di Concetto in Pazienti con Malattia Oculare Tiroidea,' si svolgerà il 14 settembre 2024, a Rotterdam, Paesi Bassi.
Il Dr. Jwu Jin Khong effettuerà la presentazione orale rapida. Il Chief Medical Officer di ACELYRIN, Dr. Shephard Mpofu, ha evidenziato il potenziale di lonigutamab di migliorare i risultati clinici attraverso la rapida soppressione della segnalazione del recettore IGF-1, ottenendo risposte robuste con basse esposizioni al farmaco. L'azienda crede che i dati supportino il potenziale di lonigutamab somministrato sottocute di fornire risposte profonde e durevoli con un dosaggio comodo e autofornito.
ACELYRIN, INC. (Nasdaq: SLRN) anunció datos positivos de su ensayo clínico de Fase 1/2 sobre lonigutamab para la enfermedad ocular tiroidea (TED), que se presentarán en la 42ª Reunión Anual de la Sociedad Europea de Cirugía Plástica y Reconstructiva Oftálmica. La presentación, titulada 'Resultados Preliminares de Seguridad, Eficacia y Calidad de Vida de Lonigutamab Subcutáneo de un Estudio de Fase 1/2 de Prueba de Concepto en Pacientes con Enfermedad Ocular Tiroidea,' tendrá lugar el 14 de septiembre de 2024, en Rotterdam, Países Bajos.
El Dr. Jwu Jin Khong realizará la presentación oral rápida. El Director Médico de ACELYRIN, Dr. Shephard Mpofu, destacó el potencial de lonigutamab para mejorar los resultados clínicos a través de la rápida supresión de la señalización del receptor IGF-1, logrando respuestas robustas con bajas exposiciones al fármaco. La compañía cree que los datos respaldan el potencial de lonigutamab administrado por vía subcutánea para proporcionar respuestas profundas y duraderas con dosificación conveniente y autoadministrada.
ACELYRIN, INC. (Nasdaq: SLRN)는 갑상선 안병증 (TED)에 대한 론구타맙의 임상 시험 1/2 Phase에서 긍정적인 데이터를 발표할 예정이며, 유럽 안과 성형 및 재건 수술 학회의 제42회 연례 회의에서 발표하여 진행될 것입니다. 발표 제목은 '갑상선 안병증 환자를 위한 임상 1/2 개념 증명 연구에서의 피하 론구타맙의 초기 안전성, 효능 및 삶의 질 결과'이며, 2024년 9월 14일 네덜란드 로테르담에서 진행될 예정입니다.
Dr. Jwu Jin Khong이 빠른 구술 발표를 할 것입니다. ACELYRIN의 수석 의료 책임자 Dr. Shephard Mpofu는 론구타맙이 IGF-1 수용체 신호를 빠르게 억제함으로써 임상 결과를 개선할 수 있는 잠재력을 강조하며, 낮은 약물 노출로도 강력한 반응을 얻을 수 있다고 밝혔습니다. 회사는 이 데이터가 피하에서 투여되는 론구타맙이 편리하고 자가 투여 가능한 용법으로 깊고 지속적인 반응을 제공할 수 있는 가능성을 지원한다고 믿고 있습니다.
ACELYRIN, INC. (Nasdaq: SLRN) a annoncé des données positives de son essai clinique de Phase 1/2 sur lonigutamab pour maladie oculaire thyroidienne (TED) qui seront présentées lors de la 42e Réunion Annuelle de la Société Européenne de Chirurgie Plastique et Reconstructive Oculaire. La présentation, intitulée 'Résultats Préliminaires de Sécurité, Efficacité et Qualité de Vie de Lonigutamab Sous-Cutané d'une Étude de Phase 1/2 de Preuve de Concept chez des Patients Atteints de Maladie Oculaire Thyroidienne,' se déroulera le 14 septembre 2024 à Rotterdam, aux Pays-Bas.
Dr. Jwu Jin Khong fera la présentation orale rapide. Le Directeur Médical d'ACELYRIN, Dr. Shephard Mpofu, a souligné le potentiel de lonigutamab pour améliorer les résultats cliniques grâce à une suppression rapide de la signalisation du récepteur IGF-1, obtenant des réponses robustes avec de faibles doses de médicament. L'entreprise croit que les données soutiennent le potentiel du lonigutamab administré par voie sous-cutanée pour fournir des réponses profondes et durables avec un dosage pratique et autoadministré.
ACELYRIN, INC. (Nasdaq: SLRN) gab positive Daten aus seiner Phase 1/2 klinischen Studie zu lonigutamab bei Schilddrüsenaugenkrankheit (TED) bekannt, die auf dem 42. Jahreskongress der Europäischen Gesellschaft für Ophthalmoplastische und Rekonstruktive Chirurgie präsentiert werden. Die Präsentation mit dem Titel 'Vorläufige Sicherheits-, Wirksamkeits- und Lebensqualitäts-Ergebnisse von subkutanem Lonigutamab aus einer Phase 1/2 Machbarkeitsstudie bei Patienten mit Schilddrüsenaugenkrankheit' findet am 14. September 2024 in Rotterdam, Niederlande, statt.
Dr. Jwu Jin Khong wird die rasche mündliche Präsentation halten. Der Chief Medical Officer von ACELYRIN, Dr. Shephard Mpofu, hob das Potenzial von lonigutamab hervor, klinische Ergebnisse durch schnelle Unterdrückung der IGF-1-Rezeptorsignalgebung zu verbessern und dabei robuste Reaktionen bei geringer Arzneimittelaussetzung zu erzielen. Das Unternehmen glaubt, dass die Daten das Potenzial für subkutan verabreichtes lonigutamab unterstützen, um tiefgehende und nachhaltige Antworten mit einer praktischen, selbstverwalteten Dosierung zu bieten.
- Positive proof-of-concept data from Phase 1/2 clinical trial of lonigutamab for TED
- Potential for rapid suppression of IGF-1 receptor signaling with lonigutamab
- Possibility of achieving robust clinical responses with low drug exposures
- Potential for deep and durable responses with convenient, self-administered dosing
- None.
Insights
The preliminary data from ACELYRIN's Phase 1/2 trial of lonigutamab in thyroid eye disease (TED) shows promising results. The rapid suppression of IGF-1R signaling suggests potential for improved clinical outcomes with low drug exposures. This could be a significant advancement in TED treatment, offering deep and durable responses with convenient subcutaneous self-administration.
However, it's important to note that these are early-stage results. The efficacy, safety and quality of life outcomes need to be thoroughly evaluated in larger, late-stage trials. The potential for lonigutamab to outperform existing treatments or address unmet needs in TED management remains to be seen. Investors should closely monitor upcoming data presentations and future trial results to assess the drug's true potential in the competitive ophthalmology market.
While the announcement of positive proof-of-concept data is encouraging for ACELYRIN, it's important to temper expectations. This early-stage success doesn't guarantee approval or commercial viability. The TED market is competitive, with established treatments already available.
Investors should consider:
- The potential market size for TED treatments
- ACELYRIN's financial position and burn rate during clinical development
- The company's ability to advance lonigutamab through costly late-stage trials
- Potential partnerships or licensing deals that could offset development costs
Given the early stage of development, this news likely won't have an immediate significant impact on ACELYRIN's stock price. However, it does provide a positive signal for the company's pipeline and could attract investor interest in the long term.
Rapid-fire Oral Presentation to Highlight Efficacy, Safety, and Quality of Life Outcomes
LOS ANGELES, Sept. 10, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive data from its Phase 1/2 clinical trial of lonigutamab (an anti-insulin-like growth factor 1 receptor, or IGF-1R) in thyroid eye disease (TED) will be shared in a rapid-fire oral presentation at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery (ESOPRS) taking place from September 12-14, 2024 in Rotterdam, Netherlands. Details of the data presentation are as follows:
| Title: | “Preliminary Safety, Efficacy, and Quality of Life Outcomes of Subcutaneous Lonigutamab (Anti–Insulin-Like Growth Factor 1 Receptor [IGF-1R]) from a Phase 1/2 Proof of Concept Study in Patients with Thyroid Eye Disease (TED)” |
| Session Type: | Rapid-fire Oral Presentation |
| Abstract ID: | 24-330 |
| Date/Time: | Saturday, September 14, 2024; 3:45 – 3:50 PM CEST |
| Presenter: | Jwu Jin Khong, M.D. Ph.D., Clinical Senior Lecturer in the Department of Surgery at the University of Melbourne and Consulting Ophthalmologist at the Royal Victorian Eye and Ear Hospital and the Austin Hospital |
“The rapid suppression of IGF-1 receptor signaling observed with lonigutamab could potentially improve clinical outcomes for patients by achieving robust clinical responses with low drug exposures,” said Shephard (Shep) Mpofu, M.D., Chief Medical Officer of ACELYRIN. “Importantly, we believe these data are supportive of the potential for subcutaneously-delivered lonigutamab to provide deep and durable responses with convenient, self-administered dosing.”
About Lonigutamab
Lonigutamab is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes, and in preclinical binding and functional laboratory assays, it has been shown to be 75-fold more potent. The characteristics of lonigutamab that enable subcutaneous delivery also enable the potential for longer-term, convenient dosing, which can potentially improve depth and durability of clinical response.
About ACELYRIN, INC.
ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease.
For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding ACELYRIN’s ability to address unmet needs of patients, business plans and potential future benefits of our pipeline. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates, the risk that future results could differ materially and adversely from early clinical data, and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law.
ACELYRIN Contacts:
Tyler Marciniak
Vice President of Investor Relations and Corporate Affairs
investors@acelyrin.com
media@acelyrin.com
FAQ
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