Priovant’s brepacitinib is a dual inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1). Image credit: eamesBot / Shutterstock.

Priovant Therapeutics has high expectations for its lead candidate brepocitinib and plans to evaluate the therapy in multiple autoimmune indications.

In 2025, the company is expecting topline data from two Phase III trials, the VALOR trial (NCT05437263) and CLARITY trial (NCT06431373), evaluating the therapy in dermatomyositis and non-anterior non-infectious uveitis indications, respectively.

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Priovant’s CEO Benjamin Zimmer, in an interview with the Clinical Trials Arena, highlighted that brepocitinib’s ability to inhibit tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) allows for a “unique” cytokine suppression profile. Thereby, allowing the therapy to suppress several cytokines that are linked to several different autoimmune diseases.

Zimmer said brepocitinib showed efficacy in seven different indications including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease, in Phase II trials. However, the company prioritised the therapy’s development in dermatomyositis and uveitis citing the “transformative” potential of brepocitinib in these indications.

TYK2/JAK1 inhibitors have been an area of interest for multiple autoimmune indications such as inflammatory bowel disease, psoriasis, psoriatic arthritis, and atopic dermatitis. Whilst most of the autoimmune space is dominated by monoclonal antibodies like AbbVie’s Humira (adalimumab), GlobalData estimates that there are currently 58 TYK2/JAK1 inhibitors in development.

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The placebo-controlled Phase III VALOR trial has enrolled 241 patients with dermatomyositis. The study’s primary endpoint of total improvement score at 52 weeks, is a resignation endpoint according to Zimmer. The endpoint is a composite that includes six measures of dermatomyositis disease activity.

Secondary endpoints include steroid-sparing effect of brepocitinib, and individual measurements of skin and muscle disease and activity and other organs, even beyond those in the total improvement score.

Zimmer notes that Priovant is also looking to evaluate brepocitinib other conditions but did not disclose any specific indications. Last month, the US Food and Drug Administration (FDA) granted a fast track designation to brepocitinib as a treatment for non-infectious uveitis, based on positive data from the Phase II NEPTUNE trial (NCT05523765). Concurrently, Pirovant also started enrolment in Phase III CLARITY trial, which consists of two sub-studies each enrolling g 150 patients with non-anterior non-infectious uveitis.