Clinical Trials
57
14 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1983
Active, not recruiting
13
22.8%
Completed
27
47.4%
Enrolling By Invitation
1
1.8%
No Longer Available
2
3.5%
Recruiting
5
8.8%
Terminated
9
15.8%
No approval data available
- Santa Ana Bio has dosed the first cohort in a first-in-human Phase 1 trial of SAB01, a bispecific antibody that co-engages KIT and Siglec-6 to selectively deplete mast cells. - The randomized, double-blind, placebo-controlled single ascending dose study (NCT07815561) evaluates subcutaneous and intravenous SAB01 in healthy adults, with primary objectives of safety, pharmacokinetics, and pharmacodynamics. - SAB01 is designed to uncouple mast cell depletion from broad KIT inhibition, potentially avoiding toxicities such as hematopoietic stem cell and melanocyte effects seen with existing KIT-targeted antibodies. - The Phase 1 start marks Santa Ana Bio's first entry into the clinic, while its CD40-targeted glucocorticoid antibody-drug conjugate SAB05 advances through IND-enabling studies toward a 2027 clinic entry.
- Celldex Therapeutics has issued a pipeline update that presents a mixed picture of its ongoing development programs. - The update has drawn attention from the investment community, with reactions varying based on existing narratives around the company. - The company's pipeline progress remains a key focus for stakeholders tracking its clinical and commercial trajectory. - The mixed nature of the update underscores the inherent uncertainty in biopharmaceutical pipeline development.
- Celldex Therapeutics has initiated EMBARQ-ColdU and SD, a global phase 3 program evaluating barzolvolimab in adults with cold urticaria and symptomatic dermographism who remain symptomatic despite antihistamine therapy. - The randomized, double-blind, placebo-controlled trial will enroll approximately 240 patients across 75 sites in seven countries, with the primary endpoint measuring complete response rates at week 12. - Previous phase 2 results showed up to 75% of cold urticaria patients and 67% of symptomatic dermographism patients achieved partial or complete response by week 12, with no advanced therapies currently approved for these conditions affecting over 533,000 patients in the US and Europe.
- Over 100 pharmaceutical companies are actively developing more than 100 pipeline drugs for eczema treatment, representing a significant expansion in therapeutic options for this chronic inflammatory skin condition. - Sanofi's Amlitelimab achieved all primary and key secondary endpoints in the Phase III COAST 1 study, demonstrating statistically significant skin clearance in patients with moderate-to-severe atopic dermatitis at Week 24. - The pipeline features diverse mechanisms of action including OX40 ligand inhibitors, interleukin receptor antagonists, and STAT6 transcription factor degraders, with approximately 10+ drugs in late-stage development. - Recent clinical milestones include positive Phase I results for Concerto Biosciences' ENS-002 topical biotherapeutic and FDA clearance for Sitryx Therapeutics' SYX-5219 Phase Ib trial.
- Celldex Therapeutics' Phase 2 study of barzolvolimab in eosinophilic esophagitis met its primary endpoint, achieving profound mast cell depletion with statistical significance (p<0.0001). - Despite achieving a 65% reduction in esophageal mast cells, the treatment failed to improve clinical symptoms or endoscopic disease measures compared to placebo. - The results provide direct evidence that mast cells are not primary drivers of EoE pathogenesis, leading Celldex to discontinue development in this indication. - Barzolvolimab demonstrated a favorable safety profile and continues development in other mast cell-driven conditions including chronic urticaria and atopic dermatitis.
- Avalo Therapeutics has appointed Rita Jain, M.D., a rheumatologist with over two decades of biopharmaceutical leadership experience, to its Board of Directors. - The appointment comes as the company advances AVTX-009, a high-affinity anti-IL-1β monoclonal antibody, through a Phase 2 LOTUS trial for hidradenitis suppurativa. - Dr. Jain previously served as Chief Medical Officer at ChemoCentryx, where she advanced Tavneos (avacopan), a first-in-class treatment for ANCA-associated vasculitis. - The Phase 2 LOTUS trial results for hidradenitis suppurativa are expected to read out in the middle of next year.
- Celldex Therapeutics reports significant progress in Phase 3 trials of barzolvolimab for chronic spontaneous urticaria (CSU), with active enrollment ongoing across 40 countries and 500 sites. - The company's Phase 2 CSU study demonstrated unprecedented efficacy with 71% of patients achieving complete response at Week 52, setting a new standard in disease treatment. - Celldex expands its portfolio by initiating Phase 2 trials in atopic dermatitis and launching CDX-622, their first bispecific antibody targeting inflammatory diseases.
• The global chronic spontaneous urticaria (CSU) market is projected to grow from $15.1 million in 2024 to $36 billion by 2035, driven by rising diagnosis rates and innovative biologic therapies. • Pharmaceutical giants including Novartis, Sanofi, Roche, and AstraZeneca are advancing promising treatments beyond traditional antihistamines, with BTK inhibitors like remibrutinib and rilzabrutinib showing significant potential in clinical trials. • Treatment paradigms are shifting from conventional approaches toward personalized medicine and targeted therapies, offering new hope for the approximately 2.8 million CSU patients across major markets who often experience inadequate symptom control.
- The ACTG has initiated the ACACIA (A5417) study, a Phase 2 trial, to assess the safety and efficacy of broadly neutralizing antibodies (bNAbs) in HIV treatment. - ACACIA will evaluate the combination of 3BNC117-LS and 10-1074-LS with antiretroviral therapy (ART) in adults living with HIV across four African countries. - The trial includes an analytic treatment interruption (ATI) phase to determine if the intervention can control HIV in the absence of ART, a key step in HIV cure research. - ACACIA aims to optimize the therapeutic benefit of bNAbs by administering them when viral load is high and assessing their long-lasting immunologic effects.
- Celldex Therapeutics has begun a Phase 2 clinical trial to evaluate barzolvolimab for treating moderate to severe atopic dermatitis, a chronic inflammatory skin condition. - Barzolvolimab, a humanized monoclonal antibody, targets mast cells implicated in atopic dermatitis, potentially offering a novel therapeutic approach. - The randomized, double-blind, placebo-controlled study will assess the efficacy and safety of barzolvolimab, with primary endpoint focused on pruritus reduction. - Positive clinical data from ongoing trials could position Celldex favorably in the dermatology market, addressing unmet needs in atopic dermatitis treatment.
