HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting (ACAAI) in Orlando, Florida by Dr. Steven Greenberg, Vice President of Clinical Sci ...

Core Insights - RAPT Therapeutics and Shanghai Jeyou Pharmaceutical announced positive topline data from a Phase 2 trial of RPT904 for chronic spontaneous urticaria, showing comparable efficacy and safety to omalizumab [1][4][5] Study Design and Results - The Phase 2 study enrolled 137 adult patients with chronic spontaneous urticaria inadequately controlled by H1 antihistamines, randomized into three arms: RPT904 Q8W, RPT904 Q12W, and omalizumab Q4W [2] - The primary endpoint was the change in the seven-day urticaria activity score (UAS7) at Weeks 8, 12, and 16, with key secondary endpoints including the proportion of patients achieving UAS7=0 [2] - RPT904 demonstrated numerically greater improvements in UAS7 scores and a higher proportion of patients achieving UAS7=0 compared to omalizumab at all time points [3] Efficacy Data - Mean baseline UAS7 scores were similar across treatment arms, with RPT904 Q8W showing a least squares mean change from baseline of -20.51 at Week 8, -22.14 at Week 12, and -23.20 at Week 16 [3] - The proportion of patients with UAS7=0 at Week 16 was 45.65% for RPT904 Q8W and 43.48% for Q12W, compared to 33.33% for omalizumab [3] Safety Profile - RPT904 was well tolerated, with no serious adverse events related to the study drug and no treatment-related discontinuations [3][4] Future Development Plans - Jeyou plans to advance RPT904 to Phase 3 development in China, while RAPT will discuss the Phase 3 development path with the FDA [4][5] - RAPT also aims to initiate a Phase 2b trial in food allergies by the end of the year [5] Background Information - Chronic spontaneous urticaria is characterized by sudden onset hives and intense itch, with a need for therapies targeting the underlying IgE-autoantibody pathology [7] - RPT904 is a novel anti-IgE monoclonal antibody designed to provide extended pharmacokinetics compared to omalizumab, targeting the same epitope [8]

Core Insights - Novartis announced FDA approval for Rhapsido® (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment, marking it as the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU [2][4][6] Group 1: Product Overview - Rhapsido is administered as a pill taken twice daily, offering a non-injection alternative that does not require lab monitoring [2][5] - The drug works by inhibiting the release of histamine and other proinflammatory mediators through targeting BTK, providing a novel approach to CSU treatment [2][4] - Clinical trials (REMIX-1 and REMIX-2) demonstrated that Rhapsido significantly improved symptoms such as itch and hives compared to placebo, with one-third of patients achieving complete absence of symptoms by Week 12 [3][5] Group 2: Market Context - Approximately 1.7 million people in the US suffer from CSU, with over half remaining symptomatic despite higher doses of antihistamines [4][5] - Current treatment options include antihistamines and injectable treatments, but less than 20% of eligible patients receive the latter [2][4] - The approval of Rhapsido is seen as a significant advancement in CSU care, providing patients with a convenient oral option that can be easily integrated into their daily routines [2][6] Group 3: Future Developments - Novartis is also exploring remibrutinib for other conditions such as chronic inducible urticaria, food allergy, and hidradenitis suppurativa, indicating a broader strategy to expand its immunology portfolio [4][6] - The company is committed to investing in innovative therapies aimed at improving care for immune-related conditions [6]

Core Insights - Celldex announced new data showing rapid and strong efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), regardless of baseline immunoglobulin E (IgE) levels [1][3][8] Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks; 41% of patients reported a complete response at 76 weeks [5][8] - The study demonstrated a well-tolerated safety profile throughout the treatment period [5] Mechanism of Action - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The data reinforces the role of mast cells as key drivers of CSU, indicating that barzolvolimab could be a meaningful treatment for all patients, including those with low IgE levels [3][8] Ongoing Research - Celldex is currently enrolling patients in a global Phase 3 Program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] About Chronic Spontaneous Urticaria (CSU) - CSU is characterized by hives or wheals lasting 6 weeks or longer without identifiable triggers, often resulting from mast cell activation [11]

Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Efficacy of Barzolvolimab - At Week 52, 71% of patients receiving 150 mg Q4W of barzolvolimab achieved a complete response in CSU, demonstrating the highest rate of complete response observed in a well-controlled study[16] - At Week 12, 51% of patients on the 150 mg Q4W dosage achieved complete response, compared to only 6% in the placebo group[16] - 7 months post-treatment (Week 76), 41% of patients in the 150 mg Q4W group sustained a complete response[16] - At Week 76, 47%-56% of barzolvolimab patients had well controlled disease[50] Safety and Tolerability - Barzolvolimab demonstrates a well-tolerated, long-term safety profile in Phase 2 trials[25] - Most adverse events are mild (Grade 1), KIT-mediated effects and reversible during follow-up period[27] - Localized hair color changes/lightening occurred in 48 patients through 52 weeks of treatment, with >90% already resolved at study closure[36] - Small areas of hypo-pigmentation occurred in 30 patients through 52 weeks of treatment, with >70% already resolved at study closure[36] Impact on Quality of Life - 92% of patients report moderate to high impact from CSU on their daily life[11] - At Week 76, 40%-48% of patients on barzolvolimab reported CSU had no impact (0-1) on their quality of life[53] - At Week 52, 82% of patients on the 150 mg Q4W dosage reported CSU had no impact (0-1) on their quality of life[57]

Summary of Celldex Therapeutics (CLDX) Conference Call Company Overview - **Company**: Celldex Therapeutics (CLDX) - **Focus**: Development of Barzolumab for chronic spontaneous urticaria (CSU) Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting chronic spontaneous urticaria (CSU) - **Current Treatment Landscape**: Existing treatments are inadequate for many patients, highlighting the need for new options Core Findings from the Conference Call 1. **Barzolumab Phase II Study Results**: - Barzolumab shows the highest reported complete response rate in CSU treatment at every time point [7][12][30] - Complete response rates reached 51% at 12 weeks and 71% at 52 weeks, with 41% maintaining a complete response at 76 weeks post-treatment [30][31] - 93% of patients experienced a clinically meaningful reduction in disease burden during the active treatment period [12] 2. **Patient Quality of Life**: - 92% of patients report CSU impacts all aspects of their daily lives, with significant correlations between complete response and improved quality of life [11][36] - 48% of patients reported no impact on their daily quality of life seven months after treatment [35] 3. **Safety Profile**: - Barzolumab has a well-tolerated safety profile with no new safety signals identified during the follow-up period [20][28] - Common adverse events include mild decreases in neutrophil counts and subtle pigmentation changes, which are reversible [21][24] 4. **Market Potential**: - The drug is positioned as a potential first-line treatment for patients with antihistamine-refractory moderate to severe CSU [39] - High excitement among physicians regarding Barzolumab's efficacy and safety profile, which may influence treatment decisions [39] 5. **Ongoing Research and Development**: - Phase III studies are underway, with enrollment expected to complete by summer 2026 [39] - The company is focused on confirming the efficacy and safety of Barzolumab in larger patient populations [39] Additional Important Insights - **Patient Demographics**: The study included patients with severe CSU, with 70% having a UAS7 score greater than 28 at baseline [17] - **Long-term Efficacy**: The sustained response after treatment cessation suggests potential normalization of mast cell activity in patients [44] - **Physician Perspectives**: Physicians are optimistic about the potential for Barzolumab to change treatment paradigms for CSU, particularly for patients who have not responded to existing therapies [42][46] Conclusion - Celldex Therapeutics is making significant strides in the treatment of chronic spontaneous urticaria with Barzolumab, demonstrating promising efficacy and safety data that could redefine treatment standards in this area. The ongoing Phase III studies will be crucial in validating these findings and expanding treatment options for patients suffering from this debilitating condition.

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]