New long-term data for Gilead’s PBC programme lends support ahead of FDA decision
20 May 2024
Clinical ResultPhase 3Acquisition
Gilead’s primary biliary cholangitis (PBC) candidate – gained via its $4.3-billion acquisition of CymaBay Therapeutics – looks primed to succeed in a second Phase III trial, bolstering the argument that seladelpar could become one of the biopharma’s growth drivers in the years to come. Interim data from the long-term ASSURE study, presented this week at the Digestive Disease Week conference, show that the oral PPAR-delta agonistPPAR-delta agonist significantly improved several disease measures.
Seladelpar is currently under FDA review based on data from the Phase III RESPONSE study, with a decision expected by August 14.
For ASSURE’s composite endpoint, 70% of patients receiving seladelpar achieved an alkaline phosphatase (ALP) level
After two years, the responder rate held steady at 70% in 20 measurable patients, of which about 25% achieved ALP normalisation.
Gilead also reported that seladelpar led to a rapid and durable reduction in the moderate-to-severe pruritus symptoms reported by 60 patients at baseline. By month six, their itching improved by a mean Numerical Rating Scale (NRS) reduction of 3.5 points, which was sustained through month 12.
The open-label ASSURE study is enrolling up to 500 patients with PBC who have already participated in another clinical trial of seladelpar, with the majority having a gap of one year or more between trials. It is designed to evaluate the long-term safety and tolerability of the PPAR-delta agonistPPAR-delta agonist.
In the RESPONSE study, PBC patients who received seladelpar with pruritus reported a mean NRS reduction of 3.2 points at six months, versus 1.7 points for placebo. Additionally, 61.7% of patients in the intervention arm met the composite endpoint after one year, compared with 20% for placebo.
Before seladelpar’s potential August approval, however, the FDA will make a decision on Ipsen and Genfit’s oral PPAR-alpha/delta agonistPPAR-alpha/delta agonist elafibranor in PBC on June 10.
Both experimental treatments met the primary composite endpoint in their respective pivotal studies, but seladelpar was the only one to achieve statistically significant itch reduction. For more analysis, see KOL Views Q&A: Leading expert sizes up PPAR battle between elafibranor, seladelpar in PBC.
A marketing filing for seladelpar has also been submitted in Europe, where the assessment is estimated to be completed early next year.
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