Triveni Bio Doses First Patient in Phase 2 Trial of TRIV-509 for Atopic Dermatitis

Triveni Bio, Inc., a biotech company focused on innovative antibody therapies for inflammation and immunology disorders, announced the dosing of the first patient in its global Phase 2 proof-of-concept trial of TRIV-509.

TRIV-509 is a dual-specific monoclonal antibody targeting kallikreins 5 and 7 (KLK5/7), key enzymes implicated in moderate-to-severe atopic dermatitis (AD). Overexpression of KLK5/7 drives barrier dysfunction, inflammation, and itch in AD, making them validated therapeutic targets.

Advancing a Novel Mechanism

"The initiation of our Phase 2 study represents important progress toward breaking the existing AD treatment efficacy ceiling,"

• Vishal Patel, Ph.D., CEO of Triveni Bio.

• Up to two-thirds of AD patients experience suboptimal outcomes with current therapies.
• TRIV-509’s dual mechanism addresses barrier dysfunction, inflammation, and itch, offering potential to shift the therapeutic paradigm.
• This trial is the second of three TRIV-509 clinical trials planned for 2025.

Clinical Rationale Highlighted at EADV 2025

At the European Academy of Dermatology and Venereology (EADV) Congress in Paris, Triveni presented data from an ex vivo skin explant study:

• TRIV-509 normalized skin barrier function, reduced epidermal hyperproliferation, and decreased inflammatory cytokine release.
• Anti-inflammatory effects were observed across Th1, Th2, and Th17/22 pathways, which correlates with broader clinical efficacy.

"Our EADV data show KLK5/7 inhibition delivers rapid, marked improvements across multiple AD biomarkers. These findings strongly support TRIV-509 as a differentiated and potent treatment option."

• Bhaskar Srivastava, M.D., Ph.D., Chief Medical Officer.

Pipeline Expansion

Triveni is also advancing TRIV-573, a next-generation bispecific antibody combining KLK5/7 inhibition with IL-13 blockade, expected to enter clinical trials in first half of 2026.

TRIV-509 Key Highlights:

• Half-life extended monoclonal antibody for moderate-to-severe AD.
• Targets barrier dysfunction, inflammation, and itch.
• Demonstrated superior efficacy to IL-4R inhibition in preclinical models.
• Positioned for quarterly subcutaneous dosing.

TRIV-573 Key Highlights:

• Bispecific antibody combining TRIV-509 with potent IL-13 inhibition.
• IL-13 blockade has shown clinical improvement in AD patients.
• Currently in IND-enabling studies.

Recognition and Momentum

Triveni’s progress comes alongside its Fierce Biotech 2025 Fierce 15 award, highlighting its rapid growth and potential to deliver transformative therapies in areas of unmet need.

About Triveni Bio:

Triveni Bio is a biotechnology company developing novel antibody-based therapies for inflammatory and immunological disorders, with a focus on addressing unmet clinical needs through mechanistically differentiated approaches.

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