Amgen (AMGN) and Kyowa Kirin revealed encouraging top-line findings from the ASCEND Phase 3 long-term extension study for rocatinlimab, an experimental medication used to treat moderate-to-severe atopic dermatitis in adults and adolescents. The study showed that the T-cell rebalancing therapy had a steady safety profile and ongoing therapeutic efficacy.
The ASCEND trial is a component of the extensive ROCKET Phase 3 program, which aims to assess rocatinlimab’s long-term safety and effectiveness. Adult patients who had finished 24 weeks of treatment in a previous ROCKET program trial and continued treatment for an additional 32 weeks in the ASCEND research were the focus of the analysis.
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According to the study’s main conclusions, most patients who received rocatinlimab monotherapy at either an eight-week or four-week dosage reported long-lasting improvements in skin clearance, decreased itching, and a reduction in the overall severity and extent of their atopic dermatitis after a year of treatment.
Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies,
These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease and provide further information on rocatinlimab’s durability of response and long-term safety profile, which we will continue to monitor.
Jay Bradner
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An anti-OX40 monoclonal antibody called rocatinlimab is intended to suppress and lessen pathogenic T cells, which are a major contributor to atopic dermatitis. Rebalancing the immune system’s response could make the treatment a first-in-class treatment.
The ASCEND study’s rocatinlimab safety profile aligned with earlier results. Headache, influenza, cough, rhinitis, aphthous ulcers, and upper respiratory infections were the most frequent treatment-emergent side effects. Adverse event-related discontinuation rates were modest.
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Ten to fifteen percent of adults and up to ten percent of children suffer from atopic dermatitis, a chronic inflammatory skin condition. Dry, itchy skin that can be uncomfortable and interfere with day-to-day activities is its defining feature.
Amgen and Kyowa Kirin want to present the complete findings of the ASCEND trial in a peer-reviewed journal or at a future medical convention. With the exception of Japan, where Kyowa Kirin maintains all rights, Amgen is spearheading the businesses’ global development and marketing of rocatinlimab.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
