Based on the latest data from the REZOLVE-AD Phase 2b study, the efficacy and safety of Rezpegaldesleukin (Rezpeg) has been highlighted in the treatment of atopic dermatitis (AD). The study, which lasted for 16 weeks, involved a total of 393 patients who were randomized into different treatment arms and received at least one dose of the study treatment or placebo.
One of the significant findings was the dose-dependent percentage improvement in the Eczema Area and Severity Index (EASI) at week 16. The study showed a clear separation from the placebo across all time points for the study treatment arms, with all dose arms meeting the primary endpoint with statistical significance (p-value <0.001). For instance, the highest dose arm (24 µg/kg, q2w) demonstrated a 61% improvement in EASI at week 16 compared to the placebo.
Furthermore, the study also evaluated key secondary endpoints at week 16, including the Validated Investigators Global Assessment for Atopic Dermatitis (vIGA-AD), itch and pain Numerical Rating Scales (NRS), and the Dermatology Life Quality Index (DLQI). It was observed that the high-dose arm met all key secondary endpoints, with response rates significantly higher than the placebo in multiple areas.
In addition to patient-reported outcomes, the study also examined the impact of Rezpeg on biomarkers associated with AD. It was found that there was a dose-dependent increase in regulatory T cells (Tregs) and a reduction in Th2 inflammation, demonstrating the potential of Rezpeg in restoring the balance in the immune system.
Moreover, the open-label escape arm results for patients who crossed over from placebo to Rezpeg at week 16 showed rapid efficacy through 16 weeks of dosing at 24 µg/kg q2w, indicating the potential for continued positive outcomes.
The market has reacted to these announcements by moving the company's shares 2.37% to a price of $51.07. For more information, read the company's full 8-K submission here.
