On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) revealed data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study evaluating the long-term efficacy and safety of Livdelzi.
The study showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression.
Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function.
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Livdelzi continues to appear generally well tolerated, with no new safety signals or change in frequency of adverse events (AEs) with up to three years of exposure.
In August, the FDA granted accelerated approval for Gilead's Livdelzi for primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
In addition to the ASSURE data, Gilead showcased findings from two oral presentations highlighting additional analyses from the Phase 3 RESPONSE trial:
- At Month 12, the adjusted mean change from baseline in ALP for participants with cirrhosis on Livdelzi was -121.4 U/L (a decrease of approximately 35% from baseline) versus 23.2 U/L (an increase of approximately 6.6%) on placebo.
- -134.8 U/L (down 43.5%) for Livdelzi versus -18.0 U/L (a decrease of approximately 5.8%) for placebo in participants without cirrhosis.
- A secondary analysis of pruritus in RESPONSE showed that among participants with a numerical rating score (NRS) of ≥4 and NRS ≥7 at baseline, Livdelzi led to near resolution (NRS of 0 or 1) of itch at Month 12 in 26.5% and 18.8% of participants, respectively, versus 0% of participants on placebo.
Price Action: GILD stock is down 3.48% at $88.90 at last check Friday.
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