Triveni Bio Doses First Healthy Volunteers in Clinical Trial for TRIV-509, Coinciding with Preclinical Data Presentations Further Validating Novel Kallikrein 5/7 Biology in Atopic Dermatitis

-- Triveni Bio enters the clinic with TRIV-509 and plans to initiate two additional patient studies in the second half of 2025 --

-- Scientific presentations elucidate the importance of KLK5/7 in AD disease pathology and support advancement of second-generation bispecific antibody, TRIV-573, in IND-enabling studies --

WATERTOWN, Mass., May 21, 2025 /PRNewswire/ -- Triveni Bio, Inc., a biotechnology company focused on developing innovative antibody treatments for inflammation and immunology (I&I) disorders, today announced the initiation of dosing in healthy volunteers for its first-in-human Phase 1 clinical trial of TRIV-509. This study will assess the safety and tolerability of TRIV-509 and is the first of three clinical trials the company expects to begin in 2025 as Triveni advances its anti-kallikrein mechanism into patients with moderate-to-severe atopic dermatitis (AD).

"Triveni's transition into the clinic with TRIV-509 marks a significant milestone in our strategy to advance orthogonal mechanisms that deliver enhanced efficacy and convenience," stated Bhaskar Srivastava, M.D., Ph.D., Chief Medical Officer of Triveni Bio.

TRIV-509 inhibits kallikreins 5 and 7 (KLK 5/7) and is being positioned as a more convenient and differentiated treatment option for AD and other barrier-related diseases.

This milestone follows recent presentations at the Society for Investigative Dermatology (SID) 2025 Annual Meeting and the Protein Engineering & Cell Therapy Summit (PEGS).

"We are also pleased to share human ex vivo data which, alongside existing in vivo data, demonstrate TRIV-509's impact on key markers of barrier integrity and epidermal differentiation, further underscoring the critical role of KLK5 and KLK7 in AD pathogenesis," said Jennifer Dovey, Ph.D., Chief Scientific Officer of Triveni Bio.

TRIV-509 data presented at SID showed rapid improvement in skin barrier integrity and epidermal differentiation in AD patient explants. The data also showed that TRIV-509 significantly reduced epidermal thickness and abnormal maturation, markedly improved abnormal AD skin proliferation, and increased the presence of a key protein essential for skin barrier function. Collectively, these data support the significant role of KLK5/7 in AD.

Furthermore, Triveni presented data at PEGS on TRIV-573, a next-generation bispecific antibody that inhibits both KLK5/7 and IL-13. Building upon the TRIV-509 findings, this bispecific is designed to leverage the KLK5/7 mechanism to repair the skin barrier while further reducing Th2 inflammation. Preclinical data highlighted TRIV-573's favorable design characteristics, including high affinity and long half-life.

"We are highly encouraged by the progress of our first and potentially best-in-class pipeline and we look forward to initiating patient studies later this year," added Dr. Srivastava.

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.

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.

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.

Media Contact
Peg Rusconi, Deerfield Group
peg.rusconi@deerfieldgroup.com 

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SOURCE Triveni Bio