Triveni Bio Initiates Phase 2 Trial of Novel Anti-KLK5/7 Antibody TRIV-509 for Atopic Dermatitis
核心洞察
Triveni Bio (搜索) has dosed the first patient in a global Phase 2 proof-of-concept study of TRIV-509, a dual-specific monoclonal antibody targeting kallikreins 5 and 7 for moderate-to-severe atopic dermatitis (搜索) treatment.
The company presented translational data at the 2025 EADV Congress showing TRIV-509 rapidly improved multiple disease markers in AD patient skin explants, including barrier function and inflammatory cytokine reduction.
TRIV-509 demonstrated superior efficacy compared to IL-4R (搜索) inhibition in preclinical models and is positioned for convenient quarterly subcutaneous dosing to address treatment gaps for up to two-thirds of AD patients.
Triveni Bio (搜索) has achieved a significant milestone by dosing the first patient in its global Phase 2 proof-of-concept trial of TRIV-509, a dual-specific monoclonal antibody targeting kallikreins 5 and 7 (KLK5 (搜索)/7) for the treatment of moderate-to-severe atopic dermatitis (搜索) (AD). This advancement represents the second of three concurrent clinical trials for TRIV-509 planned for 2025.
The biotechnology company simultaneously presented compelling translational data at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, demonstrating the novel mechanism's potential to address current treatment limitations. According to Vishal Patel, Ph.D., Chief Executive Officer of Triveni Bio (搜索), "Current AD treatments fall short for up to two-thirds of patients. Our novel mechanism hits barrier dysfunction, inflammation, and itch and has the potential to fundamentally shift today's therapeutic paradigm."
Novel Mechanism Targets Multiple Disease Pathways
TRIV-509 represents a differentiated approach to atopic dermatitis (搜索) treatment by targeting kallikreins 5 and 7, validated targets in multiple diseases characterized by barrier dysfunction. These proteases are overexpressed in AD and central to disease pathology. The half-life extended monoclonal antibody has demonstrated the ability to directly impact each key pillar of AD: barrier dysfunction, inflammation, and itch.
The company's oral presentation at EADV, titled "TRIV-509, a dual inhibitor of KLK5 (搜索) and KLK7 (搜索), normalizes epidermal hyper-proliferation, improves barrier integrity and reduces secretion of inflammatory cytokines in atopic dermatitis (搜索) (AD) skin explants," featured results from an ex vivo explant study using AD patient skin. These data serve as a critical bridge between preclinical and clinical findings.
Promising Translational Data in Patient Samples
The EADV presentation revealed that TRIV-509 delivers rapid and substantial improvements in tissue-based hallmarks of AD. In patient skin explants, the treatment demonstrated normalization of skin barrier function, reductions in epidermal thickness, decreased skin cell hyperproliferation, and reduced release of pro-inflammatory markers.
Particularly noteworthy was the broad anti-inflammatory effect observed across Th1, Th2, and Th17/22 cytokines, which has been previously associated with greater clinical efficacy. "Our data presented at EADV demonstrate that KLK5 (搜索)/7 inhibition in AD patient skin explants leads to rapid, marked improvement in multiple markers associated with efficacy," said Bhaskar Srivastava, M.D., Ph.D., Chief Medical Officer of Triveni Bio (搜索).
Superior Preclinical Performance and Convenient Dosing
TRIV-509 has demonstrated superior efficacy compared to IL-4R (搜索) inhibition in multiple preclinical AD models. The clinical stage program is being positioned for quarterly subcutaneous dosing, offering a potentially convenient treatment option for patients with moderate-to-severe atopic dermatitis (搜索).
Expanding Pipeline with Next-Generation Bispecific
Triveni is advancing a broader pipeline alongside TRIV-509, including the next-generation bispecific antibody TRIV-573. This half-life extended second-generation therapy combines the KLK5 (搜索)/7 mechanism with a highly potent anti-interleukin 13 (IL-13 (搜索)) mechanism. IL-13 inhibition has been demonstrated in humans to improve outcomes in AD patients. TRIV-573 is currently in IND-enabling studies and is expected to enter clinical trials in the second quarter of 2026.
Recognition and Future Outlook
The dosing milestone and EADV data presentation follow Triveni's recognition as a Fierce Biotech 2025 Fierce 15 winner, underscoring the company's rapid momentum and potential to deliver transformative treatments in therapeutic areas with clear unmet medical needs. The company uses a genetics-informed, precision medicine approach to establish proof-of-concept early in the drug development process by leveraging deep insights into genetic and mechanistic biology.