Gilead touts more two-year data for seladelpar liver drug ahead of FDA verdict
05 Jun 2024
Clinical ResultPhase 3
Gilead Sciences dropped some more long-term data Wednesday bolstering seladelpar's benefit as a potential treatment for primary biliary cholangitis (PBC) ahead of a looming US approval decision in mid-August.
New data from the ASSURE trial being presented at the European Association for the Study of the Liver (EASL) congress indicate the oral PPAR-delta agonistPPAR-delta agonist, acquired through Gilead's recent $4.3-billion takeout of CymaBay, continued to show rapid and durable improvements across key markers of bile flow impairment.
"The data presented at EASL further support the sustained efficacy and safety profile of seladelpar observed across its development programme including a capacity to normalise ALP (alkaline phosphatase) values," said Timothy Watkins, head of clinical development for inflammation therapeutics at Gilead. "Seladelpar is a potential best-in-class therapy that could transform the treatment landscape for people living with PBC."
The open-label ASSURE study is enrolling up to 500 patients who have already participated in other clinical trials of seladelpar, including the pivotal RESPONSE trial. The two-year interim analysis is based on data from 179 participants as of a January 31 cut-off.
Steady improvement on composite goal
Out of 99 participants in previous studies who completed 24 months of treatment with seladelpar, the rate of those achieving target goals held steady at 70%. The same was true based on data from 20 patients that Gilead shared last month. The composite response endpoint includes having ALP levels below 1.67 times the upper limit of normal (ULN), reducing ALP levels by ≥15%, and having total bilirubin levels at or below ULN. In addition, 42% of these patients achieved ALP normalisation at 24 months.
Looking specifically at the 102 patients who completed the RESPONSE study and then went on to do six more months in ASSURE – for a total of 18 months of continuous seladelpar treatment – 62% achieved the composite response endpoint, and 33% reached normalised ALP levels. Among 29 who took seladelpar continuously for two years, 72% met the composite response endpoint, and 17% achieved normal ALP levels.
A subset of ASSURE patients also had compensated liver cirrhosis, and Gilead says they also saw clinically meaningful improvements in markers of cholestasis and liver injury after receiving seladelpar for a second year. Of 32 participants enrolled from legacy studies, 56% met the composite biochemical endpoint at 12 months and 47% saw their ALP levels normalise, without serious adverse events related to treatment.
Itch relief
Meanwhile, PBC patients who started with a baseline NRS≥4 level of pruritus continued to feel less itch over time. There was an average 3.8- and 3.1-point decrease in itch at 12 and 24 months, respectively, in participants from legacy studies. For RESPONSE participants, a mean reduction of 3.8 was observed in both continuous and former placebo participants at six months in the ASSURE study.
"Current medications fall short in about 40% of people. This is because many individuals continue to have abnormal liver tests on the current treatment options, and these treatments don't reduce one of the main relentless symptoms - pruritis," said presenter Palak Trivedi, adding that seladelpar "may meaningfully raise the bar in PBC." For more, see – KOL Views Q&A: Leading expert sizes up PPAR battle between elafibranor, seladelpar in PBC.
The FDA is also slated to decide on Ipsen and Genfit's oral PPAR-alpha/delta agonistPPAR-alpha/delta agonist elafibranor in PBC on June 10. New data presented at EASL from the Phase III ELATIVE trial show 70% of patients treated with elafibranor achieved composite endpoint of slowing disease progression measured by biochemical response after 78 weeks.
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