Triveni Doses First Subject in Global Phase 2 Proof of Concept Study of TRIV-509 in Atopic Dermatitis, Presents Translational Data at 2025 EADV Congress Demonstrating Novel Biology in Patient Samples

-- Phase 2 atopic dermatitis (AD) study advances TRIV-509, a differentiated anti-KLK5/7 antibody with the potential to deliver a new level of clinical efficacy and a convenient quarterly subcutaneous dosing option --

-- Oral presentation at EADV Congress 2025 bridges preclinical and clinical findings in AD patient explants and further validates the novel KLK5/7 mechanism --

WATERTOWN, Mass., Sept. 23, 2025 /PRNewswire/ -- Triveni Bio, Inc., a biotechnology company focused on developing innovative antibody treatments for inflammation and immunology (I&I) disorders, today announced the dosing of the first patient in its global Phase 2 proof-of-concept trial of TRIV-509.

This marks a key step in advancing the company's lead clinical stage asset TRIV-509, a dual-specific, monoclonal antibody targeting kallikreins 5 and 7 (KLK5/7), into patients with moderate-to-severe atopic dermatitis (AD). Kallikreins 5 and 7 are validated targets in multiple diseases characterized by barrier dysfunction, including AD where their overexpression is central to disease pathology.

"The initiation of our Phase 2 study represents important progress toward our goal of breaking the existing AD treatment efficacy ceiling," said Vishal Patel, Ph.D., Chief Executive Officer of Triveni Bio. "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. Initiation of this trial is the second of three concurrent clinical trials for TRIV-509 planned for 2025."

Triveni recently highlighted the clinical rationale for TRIV-509 in an oral presentation at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. The presentation, titled, "TRIV-509, a dual inhibitor of KLK5 and KLK7, normalizes epidermal hyper-proliferation, improves barrier integrity and reduces secretion of inflammatory cytokines in atopic dermatitis (AD) skin explants," featured results from an ex vivo explant study in AD patient skin.

These data serve as a critical bridge between preclinical and clinical findings, demonstrating that TRIV-509 delivers rapid and substantial improvements in tissue-based hallmarks of AD, including normalization of skin barrier as well as reductions in epidermal thickness, skin cell hyperproliferation, and the release of pro-inflammatory markers. Importantly, the broad anti-inflammatory effect was observed across Th1, Th2, and Th17/22 cytokines – which has been previously associated with greater clinical efficacy.

"Our data presented at EADV demonstrate that KLK5/7 inhibition in AD patient skin explants leads to rapid, marked improvement in multiple markers associated with efficacy. These results provide strong support for the potential of TRIV-509 as a differentiated and potent option for patients," said Bhaskar Srivastava, M.D., Ph.D., Chief Medical Officer of Triveni Bio.

Triveni is advancing a broader pipeline alongside TRIV-509 that includes next-generation bispecific antibody TRIV-573, which combines KLK5/7 with IL-13 inhibition and is expected to be in the clinic in the second quarter of 2026.

The dosing of the first patient with TRIV-509 and EADV data readout come on the heels of Triveni's recognition as a Fierce Biotech 2025 Fierce 15 winner, further underscoring its rapid momentum and potential to deliver transformative treatments in landscapes with clear therapeutic gaps.

About TRIV-509
Triveni's lead program, TRIV-509 (anti-kallikreins 5 & 7), is a half-life extended monoclonal antibody being positioned for the treatment of moderate-to-severe atopic dermatitis (AD). Through its mechanism, TRIV-509 has demonstrated the ability to directly impact each key pillar of AD – barrier dysfunction, inflammation, and itch. TRIV-509 has demonstrated superior efficacy compared to IL-4R inhibition in multiple preclinical AD models and shown rapid improvement in AD patient explants. TRIV-509 is a clinical stage program being positioned for quarterly subcutaneous dosing.

About TRIV-573
TRIV-573 is a half-life extended second-generation bispecific antibody which combines TRIV-509 with a highly potent anti-interleukin 13 mechanism (IL-13). 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 be in the clinic in the first half of 2026.

About Triveni Bio
Triveni Bio is a biotechnology company at the forefront of novel antibody-based therapies for immunological and inflammatory disorders. Using a genetics-informed, precision medicine approach, the company seeks to establish proof-of-concept early in the drug development process by leveraging deep insights into genetic and mechanistic biology. To learn more, visit www.triveni.bio.

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SOURCE Triveni Bio