Latest news with #DepartmentofDermatologyandAllergy
Business Insider
a day ago
- Health
- Business Insider
Celldex says Phase 2 Barzolvolimab study met primary endpoint
Celldex (CLDX) announced new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria, an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The data are being presented in a late breaking oral presentation at the EAACI Congress 2025. The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint-a significant improvement in UAS7 compared to placebo at 12 weeks-across all dose groups tested. Barzolvolimab also demonstrated rapid, profound complete response rates in up to 51% of patients at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. Seven months after completion of dosing, patients continue to experience profound clinical benefit, with up to 41% of patients reporting a complete response at 76 weeks and 48% of patients reporting that their disease no longer impacts their quality of life. Barzolvolimab demonstrated a well tolerated safety profile throughout the study. 'In this large Phase 2 study, patients on barzolvolimab experienced rapid, profound, durable complete response which correlated with meaningful improvements in quality of life-the goal of treatment for patients and physicians,' said Martin Metz, M.D., Professor, Department of Dermatology and Allergy, Head of Translational Research and Deputy Head of Clinical Trials at Charite – Universitatsmedizin in Berlin and the lead investigator of the study. 'By addressing the root driver of chronic spontaneous urticaria, the mast cell, barzolvolimab provided meaningful clinical benefit to more than 90% of the patients on study, including patients with severe disease refractory to omalizumab, and demonstrated a level of sustained complete response after the completion of active therapy that is unprecedented in CSU. Importantly, across this large, 76 week Phase 2 trial, barzolvolimab also presented a favorable safety profile, further supporting barzolvolimab's significant potential to become a transformative treatment option for patients suffering from this often very severe and debilitating disease.'
Yahoo
4 days ago
- Business
- Yahoo
Celldex Announces Upcoming Presentations of Barzolvolimab Phase 2 Data in Chronic Spontaneous Urticaria at EAACI 2025 Congress
Company to host webcast on Thursday, June 12 at 6:00 pm ET HAMPTON, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that data from the Company's Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland. Abstracts will be available on the meeting website Thursday, June 12th at 6:01 pm ET/ Friday, June 13th at 12:01 am CEST. Celldex will host a webcast on Thursday, June 12th at 6:00 pm ET to discuss the data. Phase 2 CSU 76 Week Efficacy and Tolerability Data Date & Time: Thursday, June 12th at 6:00 pm ET/11:00 pm BSTPresenters: Company representatives and Martin Metz, MD, Professor, Department of Dermatology and Allergy, Head of Translation Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin and lead investigator for the Phase 2 CSU studyWebcast Access: Please visit the Events section on the Investor Relations page of Celldex's website to register for the webcast. Parties interested in participating via telephone may register here to receive the dial-in numbers and unique PIN to seamlessly access the call. Date & Time: Friday, June 13th at 9:12 am BST/4:12 am ETLate Breaking Oral Presentation 100227: Sustained Disease Control Following Withdrawal of Barzolvolimab in Patients with Chronic Spontaneous UrticariaPresenting Author: Ana Maria Giménez-Arnau, MD, PhD, Associate Professor of DermatologyAutonomous University and Pompeu Fabra University Phase 2 CSU 52 Week Angioedema Data EAACI Session Date & Time: Saturday, June 14th at 3:48 pm BST/10:48 am ETOral Presentation 000588: Treatment with Barzolvolimab Leads to Sustained Improvement in Angioedema in Chronic Spontaneous Urticaria (CSU) patients: Results from 52 Weeks of TreatmentPresenting Author: Martin Metz, MD, Professor, Department of Dermatology and Allergy, Head of Translation Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin and lead investigator for the Phase 2 CSU study About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit Company ContactSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) 864-8337scavanaugh@ Patrick TillMeru Advisors(484) 788-8560ptill@
