Celldex Announces Upcoming Late Breaking Oral Presentation of 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV Congress 2024
Celldex Therapeutics (NASDAQ:CLDX) has announced that 52-week results from their Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) will be presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. The study includes patients refractory to antihistamines and biologic treatments. The presentation, titled 'Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria,' will be given by Dr. Martin Metz on September 25th. Additionally, an e-Poster showcasing 12-week data on quality of life improvements will be available at the congress.
Celldex Therapeutics (NASDAQ:CLDX) ha annunciato che i risultati a 52 settimane del loro studio clinico di Fase 2 su barzolvolimab in pazienti con orticaria spontanea cronica (CSU) da moderata a grave verranno presentati al Congresso 2024 dell'Accademia Europea di Dermatologia e Venereologia (EADV). Lo studio include pazienti refrattari agli antistaminici e ai trattamenti biologici. La presentazione, intitolata 'Barzolvolimab mostra un'alta efficacia e una sicurezza favorevole per 52 settimane in pazienti con Orticaria Spontanea Cronica,' sarà tenuta dal Dr. Martin Metz il 25 settembre. Inoltre, un e-Poster che illustra i dati di 12 settimane sui miglioramenti della qualità della vita sarà disponibile al congresso.
Celldex Therapeutics (NASDAQ:CLDX) ha anunciado que los resultados a 52 semanas de su ensayo clínico de Fase 2 sobre barzolvolimab en pacientes con urticaria espontánea crónica (CSU) de moderada a severa se presentarán en el Congreso 2024 de la Academia Europea de Dermatología y Venereología (EADV). El estudio incluye pacientes refractarios a antihistamínicos y tratamientos biológicos. La presentación, titulada 'Barzolvolimab demuestra una eficacia profunda y una seguridad favorable durante 52 semanas en pacientes con Urticaria Espontánea Crónica,' será realizada por el Dr. Martin Metz el 25 de septiembre. Además, un e-Poster que presenta datos de 12 semanas sobre las mejoras en la calidad de vida estará disponible en el congreso.
셀렉스 테라퓨틱스(Celldex Therapeutics) (NASDAQ:CLDX)는 52주 결과를 발표할 것이라고 발표했습니다. 바르졸 볼리맙(barzolvolimab)의 2상 임상 시험 결과로, 중등도에서 중증의 만성 자발 두드러기(CSU)를 앓고 있는 환자들에 대한 연구입니다. 이 연구는 항히스타민제와 생물학적 치료에 저항성을 가진 환자들을 포함합니다. 제목은 '바르졸 볼리맙은 만성 자발 두드러기 환자에서 52주 동안 깊은 효능과 우호적인 안전성을 보여준다'며, 발표자는 마틴 메츠(Martin Metz) 박사입니다. 발표는 9월 25일에 진행됩니다. 추가로, 12주 간의 삶의 질 향상 데이터를 보여주는 e-포스터도 이번 학회에서 제공됩니다.
Celldex Therapeutics (NASDAQ:CLDX) a annoncé que les résultats sur 52 semaines de leur essai clinique de Phase 2 sur barzolvolimab chez des patients souffrant d'urticaires chroniques spontanées (UCS) modérées à sévères seront présentés au Congrès 2024 de l'Académie Européenne de Dermatologie et de Vénéréologie (EADV). L'étude inclut des patients réfractaires aux antihistaminiques et aux traitements biologiques. La présentation, intitulée 'Barzolvolimab montre une efficacité profonde et une sécurité favorable sur 52 semaines chez des patients souffrant d'Urticaires Chroniques Spontanées,' sera donnée par le Dr. Martin Metz le 25 septembre. De plus, un e-poster présentant des données de 12 semaines sur l'amélioration de la qualité de vie sera disponible au congrès.
Celldex Therapeutics (NASDAQ:CLDX) hat angekündigt, dass die Ergebnisse nach 52 Wochen aus ihrer Phase-2-Studie zu Barzolvolimab bei Patienten mit mäßiger bis schwerer chronischer spontaner Urtikaria (CSU) auf dem Europäischen Kongress für Dermatologie und Venerologie (EADV) 2024 präsentiert werden. Die Studie umfasst Patienten, die resistent gegenüber Antihistaminika und biologischen Therapien sind. Die Präsentation mit dem Titel 'Barzolvolimab zeigt tiefgreifende Wirksamkeit und günstige Sicherheit über 52 Wochen bei Patienten mit chronischer spontaner Urtikaria' wird von Dr. Martin Metz am 25. September gehalten. Darüber hinaus wird ein e-Poster, das Daten zu Lebensqualitätsverbesserungen nach 12 Wochen zeigt, auf dem Kongress verfügbar sein.
- Phase 2 trial results of barzolvolimab in CSU patients to be presented at a major dermatology congress
- Study includes 52-week data, indicating long-term efficacy and safety assessment
- Trial includes difficult-to-treat patients refractory to antihistamines and biologics
- Abstract title suggests 'profound efficacy and favorable safety' of barzolvolimab
- None.
HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Amsterdam on September 25-28, 2024.
Abstracts will be available on the EADV Congress website at the start of the meeting. Presentation details are as follows:
Abstract Title: Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria
Presenting Author: Martin Metz, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin
Session: D1T01.2: Late breaking news
Date/Time: Wednesday, September 25th at 16:45-17:00 CEST (10:45 – 11:00 am ET)
In addition, an e-Poster (#P3596) entitled “Barzolvolimab treatment improves quality of life and urticaria control in patients with chronic spontaneous urticaria (CSU): Results from a Phase 2 trial” will be available at EADV in the e-poster area and on the online EADV platform. These data are from the 12 week analysis.
About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.
Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com
Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com
FAQ
What are the key findings of Celldex's barzolvolimab Phase 2 study in CSU?
When and where will Celldex (CLDX) present the 52-week results for barzolvolimab in CSU?
What patient population was included in Celldex's (CLDX) barzolvolimab Phase 2 study?
Will Celldex (CLDX) present any additional data at the EADV Congress 2024?
