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Triveni Bio Begins Phase 1 Clinical Trials for TRIV-509

Triveni Bio, Inc., a dynamic biotechnology firm dedicated to pioneering antibody therapies for inflammation and immunology disorders, has taken a significant leap with the initiation of its Phase 1 clinical trial for TRIV-509. This new treatment aims to address moderate-to-severe atopic dermatitis (AD), launching the company into a new phase of its research and development journey.

The Phase 1 trial involves dosing healthy volunteers to assess the safety and tolerability of TRIV-509, marking it as the first of three clinical studies planned for 2025 as the company seeks to refine its approach to treating AD. Bhaskar Srivastava, M.D., Ph.D., and Chief Medical Officer, emphasized the importance of TRIV-509 in the company's overall strategy. He stated, "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."

TRIV-509 operates on a mechanism meant to inhibit kallikreins 5 and 7 (KLK 5/7), presenting itself as a convenient and differentiated solution for treating AD and other similar inflammatory diseases. The clinical trial initiative follows the presentation of compelling preclinical data, showcasing the role of KLK5/7 in the underlying pathology of atopic dermatitis.

Recent scientific presentations at reputable events such as the Society for Investigative Dermatology (SID) 2025 Annual Meeting have reinforced the critical importance of KLK5 and KLK7 in skin barrier integrity and the overall pathway of AD. Jennifer Dovey, Ph.D., Chief Scientific Officer of Triveni Bio, shared vital findings, stating that the data demonstrated TRIV-509’s impact on significant markers related to skin barrier function and epithelial differentiation, showing promise for AD patients facing barrier-related challenges.

At SID, results demonstrated that TRIV-509 significantly enhanced skin barrier integrity and epidermal differentiation in patient explants. Remarkably, it also exhibited the capacity to reduce epidermal thickness and rectify abnormal maturation, thereby supporting the fundamental role of KLK5/7 in AD management.

Further building on this momentum, Triveni also presented data on its next-generation bispecific antibody, TRIV-573, at the PEGS (Protein Engineering and Cell Therapy Summit). This innovative treatment combines TRIV-509 with a potent anti-interleukin 13 mechanism (IL-13) aimed at boosting skin barrier repair while simultaneously minimizing Th2 inflammatory responses. Preclinical evaluations suggest that TRIV-573 possesses advantageous design characteristics such as high affinity and an extended half-life, making it an exciting addition to Triveni’s pipeline.

Dr. Srivastava expressed enthusiasm about the company’s developments, saying, "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."

What is TRIV-509?

TRIV-509 is a monoclonal antibody with an extended half-life specifically designed for the treatment of moderate-to-severe atopic dermatitis (AD). Its unique mechanism of action targets the three pivotal aspects of AD: barrier dysfunction, inflammation, and itch response. Preclinical data indicates that TRIV-509 has demonstrated superior efficacy in comparison to IL-4R inhibition across multiple AD models, yielding swift improvements in patient explants. This positions TRIV-509 as not just a clinical stage program but a transformative approach to managing AD.

About TRIV-573

The second product in the pipeline, TRIV-573, is a bispecific antibody developed to simultaneously inhibit both KLK5/7 and IL-13 pathways. The combination aims to harness the efficacy of TRIV-509 while benefiting from the established improvements in AD patient conditions associated with IL-13 inhibition. TRIV-573 is currently in IND-enabling studies, poised to make significant advancements in patient care and treatment outcomes in the near future.

About Triveni Bio

Triveni Bio is at the cutting edge of developing innovative antibody therapies aimed at addressing both immunological and inflammatory disorders. With a meticulous focus on genetics-informed precision medicine, the company strives to establish proof-of-concept early in the drug development process, leveraging profound insights into genetic and mechanistic biology to benefit patients globally. To dive deeper into their research and solutions, visit Triveni Bio’s website.