- Nektar Therapeutics NKTR announced topline data from a Phase 2 study of rezpegaldesleukin (LY3471851 or REZPEG) in adults with moderately-to-severely active systemic lupus erythematosus (SLE).
- Although the mid-dose level demonstrated a numeric improvement in SLEDAI-2K score compared to the placebo (with a placebo-adjusted response of 8.8% for the modified intent-to-treat (mITT) population and 13.9% for the per-protocol population), the primary endpoint was not met.
- SLEDAI-2K score stratifies the severity of systemic lupus erythematosus.
- The placebo-adjusted responses for the low- and high-doses were less than those of the mid-dose for both populations.
- The mid-dose level in the study also demonstrated consistent and potentially clinically meaningful improvements for most secondary endpoints in REZPEG-treated patients compared with placebo.
- Biomarker data demonstrated that REZPEG led to a dose-dependent proliferation of T regulatory cells, consistent with prior studies.
- Eli Lilly And Co LLY has notified Nektar that they do not intend to advance REZPEG to Phase 3 development for SLE.
- Nektar and Lilly plan to work together to determine the next steps for the planned Phase 2b study in atopic dermatitis.
- Nektar and Lilly collaborated in 2017 to develop and potentially commercialize REZPEG.
- Less than a year ago, Bristol Myers Squibb Co BMY ended the program for bempegaldesleukin in combination with Opdivo after failed study.
- Price Action: NKTR shares are down 40.20% at $1.77 during the premarket session on the last check Friday.
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