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Triveni Bio Advances Atopic Dermatitis Research with TRIV-509 Phase 2 Trial

Triveni Bio, Inc., based in Watertown, Massachusetts, has made significant strides in the fight against atopic dermatitis (AD) with the initiation of its global Phase 2 proof-of-concept trial for TRIV-509. This innovative trial, which recently dosed its first patient, aims to assess the effectiveness of this dual-specific monoclonal antibody targeting kallikreins 5 and 7 (KLK5/7), both believed to play a critical role in the pathology of AD.

Understanding Atopic Dermatitis and KLK5/7

Atopic dermatitis is a chronic inflammatory skin condition that affects millions worldwide. Traditional treatments often fall short, with many patients, especially those with moderate-to-severe forms, experiencing inadequate results. KLK5 and KLK7 are proteolytic enzymes that, when overexpressed, contribute to the skin barrier dysfunction associated with AD. By targeting these enzymes, TRIV-509 aims to restore normal skin function and alleviate symptoms.

Dr. Vishal Patel, CEO of Triveni Bio, emphasized the need for innovative solutions in AD treatment, stating, "The initiation of our Phase 2 study signifies vital progress towards breaking the existing treatment efficacy ceiling. Currently, up to two-thirds of AD patients do not achieve satisfactory control with existing therapies. Our novel approach targets multiple disease mechanisms, including barrier dysfunction and associated inflammation."

Promising Data from EADV Congress

In a recent presentation at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, Triveni highlighted compelling data supporting TRIV-509’s mechanism in AD patient skin explants. The study, 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," demonstrated remarkable improvements in skin tissue characteristics related to AD.

The findings indicated that TRIV-509 effectively normalizes the skin barrier, reduces skin cell hyperproliferation, and limits the secretion of pro-inflammatory cytokines. Notably, this anti-inflammatory action was comprehensive, impacting cytokines across various pathways traditionally linked with clinical outcomes in AD, including Th1, Th2, and Th17/22 responses.

Dr. Bhaskar Srivastava, Chief Medical Officer of Triveni Bio, stated, "Our data spotlight the ability of KLK5/7 inhibition in AD patient skin explants to facilitate swift and significant improvements in critical efficacy markers. These findings reinforce our belief in TRIV-509 as a potent therapeutic option for patients."

Looking Ahead: Future Developments in Triveni’s Pipeline

Alongside TRIV-509, Triveni Bio is also advancing a broader portfolio aimed at treating various immunological and inflammatory disorders. Among these is TRIV-573, a next-generation bispecific antibody that combines KLK5/7 targeting with IL-13 inhibition, which is anticipated to enter clinical trials in the second quarter of 2026. This pipeline expansion underscores Triveni’s commitment to developing effective treatments for patients confronting significant unmet medical needs in skin care and beyond.

The recent dosing of the first patient in the TRIV-509 trial and the favorable data shared at the EADV congress come on the heels of Triveni being named a Fierce Biotech 2025 Fierce 15 winner, highlighting the company's rapid growth and potential to introduce transformative therapies in dermatology.

As we anticipate the results of this pivotal trial, TRIV-509 represents not just a hopeful option for AD patients, but also a testament to the innovation driving modern biopharmaceutical research.