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

Triveni Bio recently announced the dosing of the first patient in its global phase 2 proof-of-concept trial evaluating TRIV-509 in moderate to severe atopic dermatitis (AD). TRIV-509 is a dual-specific monoclonal antibody targeting kallikreins 5 and 7 (KLK5/7), which are related to barrier dysfunction and inflammatory signaling central to AD pathophysiology.¹

“The initiation of our phase 2 study represents important progress toward our goal of breaking the existing AD treatment efficacy ceiling,” said Vishal Patel, PhD, Chief Executive Officer of Triveni Bio, in the news release. “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.”

The clinical rationale for TRIV-509 was recently highlighted at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, where investigators shared results from an ex vivo explant study using AD patient skin.

These data demonstrated that TRIV-509 rapidly improved barrier integrity, reduced epidermal thickness, normalized keratinocyte proliferation, and decreased the release of pro-inflammatory cytokines. Notably, broad anti-inflammatory effects were observed across Th1, Th2, and Th17/22 cytokine pathways, which Triveni noted have been associated with improved clinical efficacy in AD.

“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, MD, PhD, Chief Medical Officer of Triveni Bio, in the news release.

TRIV-509 is Triveni’s lead clinical-stage program and is designed for quarterly subcutaneous dosing. Preclinical studies have shown superior efficacy compared with IL-4R inhibition, along with rapid improvement in explant models of AD.

The company is also advancing TRIV-573, a next-generation bispecific antibody that combines KLK5/7 inhibition with IL-13 blockade. TRIV-573 is expected to enter clinical development in 2026.

Triveni first dosed healthy volunteers in its phase 1 trial in May 2025 after preclinical data supporting TRIV-509’s ability to restore skin barrier function and downregulate inflammatory processes seen in AD.²

Data presented at the 2025 Society for Investigative Dermatology Annual Meeting highlighted TRIV-509’s ability to reverse key pathological features of AD in human skin explants. In the study, skin biopsies from 3 patients with moderate to severe AD (IGA >2) were treated ex vivo with TRIV-509 for 72 hours.²

Key findings from the analysis include:

Epidermal thickness reduction: TRIV-509 reduced epidermal hyperplasia by 14% to 28% in 2 of the 3 patient samples.

Decreased keratinocyte proliferation: A marked 80% reduction in Ki-67 positive basal keratinocytes was observed, indicating significant downregulation of epidermal turnover.

Improved epidermal differentiation: Parakeratosis, a hallmark of aberrant epidermal maturation, was reduced by 31% in 1 patient’s sample.

Restoration of barrier protein DSG1: Treated samples showed up to a 313% increase in desmoglein-1–positive cells, re-establishing proper cell-cell adhesion and barrier architecture.

References

1. 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. News release. Triveni Bio. September 23, 2025. Accessed September 25, 2025. https://triveni.bio/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/
2. Mateer E, Asp E, e Sousa MS, et al. TRIV-509, a dual inhibitor of KLK5 and KLK7, rapidly improves barrier integrity and markers of epidermal differentiation in atopic dermatitis skin explants. Poster presented at: Society for Investigative Dermatology Annual Meeting; May 7-10; San Diego, California.